Multicenter, Randomised in Parallel Groups, Controlled Study to Compare Performance and Safety of Suprasorb®X+PHMB Pro With Suprasorb® X+PHMB Dressing in Treatment of Infected Venous Leg Ulcers
Phase: NA
Conditions: Venous Leg Ulcer
Sponsor: Lohmann & Rauscher

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Multicenter, randomised in parallel groups, controlled study to compare 
performance and safety of Suprasorb®X+PHMB Pro with 
Suprasorb® X+PHMB dressing in treatment of infected venous leg ulcers 
 
Protocol number: 2024-07 
 
 
 
Post-Market Clinical Follow-up Plan 
Final Version 1.1 
14 August 2025 
 
Sponsor: 
Lohmann & Rauscher GmbH & Co. KG 
Irlicher Str. 55 
56567 Neuwied  
Germany 
 
 

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Document history 
Protocol version  
Amendment reference  
N°  
Date of approval/notifica-
tion 
Number 
Classification 
1.0  
21 May 2025 
---  
---  
1.1  
14 August 2025  
1  
Administrative 
incorporating 
also 
changes introduced by Memorandum 
no 1 version 1.0 dated 13.08.2025 
 
 

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Signatures 
Sponsor  
Lohmann & Rauscher GmbH & Co. KG 
Irlicher Str. 55 
56567 Neuwied 
 
On behalf of the sponsor 
Daria Trofimenko, MD 
04-Sep-2025 
 
(Senior Manager Clinical Regulatory Affairs) 
 
 
 
Date 
Signature 
 
 
 
Dr Martin Abel 
04-Sep-2025 
i.V. 
(Head of Clinical Regulatory Affairs) 
 
 
 
Date 
Signature 
 
 
 
Oliver Opitz 
04-Sep-2025 
ppa. 
(Director Quality & Regulatory Affairs) 
 
 
 
Date 
Signature 
 
 
 
Alexandra Jaszyk 
04-Sep-2025 
ppa. 
(Director of Legal Affairs and Insurance) 
 
 
 
Date 
Signature 
 
CRO 
AXCELLANT, Patrycja Buczak-Kula 
ul. Elektoralna 11/17, 
00-137 Warszawa, 
Poland 
 
On behalf of the CRO 
 
Patrycja Buczak-Kula 
 
 
Project Director 
 
 
 
Date 
Signature 
 

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Investigator‘s Agreement 
I hereby certify that I have read the present study protocol and agree to conduct the study in accord-
ance with the provisions of this study protocol. 
 
Investigator 
 
________________________________________ 
 
 
                                            
Name (print) 
 
 
 
 
 
 
____________________   
_______________________________  
 
                                            
Date 
 
 
 
Signature 
 

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1. Table of contents 
1. 
Table of contents ............................................................................................................................ 5 
2. 
Synopsis .......................................................................................................................................... 8 
3. 
Introduction and Justification ....................................................................................................... 12 
3.1 
Medical and scientific background ........................................................................................ 12 
3.2 
Current clinical and preclinical data for both products ......................................................... 12 
3.3 
Justification of the study design ............................................................................................ 13 
3.4 
Study related risks ................................................................................................................. 15 
3.5 
Benefit-risk ratio of the study ............................................................................................... 15 
4. 
Study devices ................................................................................................................................ 16 
4.1 
Suprasorb® X+PHMB Pro Antimicrobial HydroBalance wound dressings/ packing rope ...... 16 
4.2 
Reference therapy ................................................................................................................. 18 
4.3 
Additional measures .............................................................................................................. 18 
5. 
Study Details ................................................................................................................................. 20 
5.1 
Study Design .......................................................................................................................... 20 
5.2 
Study endpoints..................................................................................................................... 21 
5.2.1 
Primary endpoint ............................................................................................................. 21 
5.2.2 
Secondary endpoints ....................................................................................................... 21 
5.3 
Study Population ............................................................................................................. 21 
5.3.1 
Inclusion criteria .............................................................................................................. 21 
5.3.2 
Exclusion criteria .............................................................................................................. 22 
5.4 
Study methods ................................................................................................................. 22 
5.4.1 
Modified CDC definition and TILI Score ........................................................................... 22 
5.4.2 
Grade of wound exudate ................................................................................................. 23 
5.4.3 
Assessment of vascular status ......................................................................................... 23 
5.4.4 
Maceration score ............................................................................................................. 23 
5.4.5 
NRS................................................................................................................................... 24 
5.4.6 
Wound-QoL-17 ................................................................................................................ 24 
5.4.7 
Wound Photos ................................................................................................................. 24 
5.4.8 
Pressure measurement ................................................................................................... 24 
5.4.9 
WHAT Tool ....................................................................................................................... 25 
6. 
Study conduct ........................................................................................................................ 26 
6.1 
Study duration and time plan ................................................................................................ 26 
6.2 
Patient recruitment ............................................................................................................... 26 
6.3 
Randomisation procedure ..................................................................................................... 26 
6.4 
Visit schedule ......................................................................................................................... 26 
6.4.1 
Screening visit (V0, Day -7) .............................................................................................. 28 
6.4.2 
Baseline visit (V1, Day 0) .................................................................................................. 28 
6.4.3 
Interim visit (V2, D10 ±2) ................................................................................................. 29 

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6.4.4 
Additional visits (VA1, VA2, etc., at each dressing change) ............................................ 30 
6.4.5 
Final Visit (V3, Day 21±2 or the day the complete healing is achieved or Early Termination)
 
30 
6.5 
Termination Criteria .............................................................................................................. 31 
6.5.1 
Individual ......................................................................................................................... 31 
6.5.2 
Centre-specific ................................................................................................................. 31 
6.5.3 
General ............................................................................................................................ 31 
7. 
Data Management ........................................................................................................................ 32 
7.1 
Data Management procedures ............................................................................................. 32 
7.2 
Procedures for data retention ............................................................................................... 32 
8. 
Statistical Considerations ............................................................................................................. 33 
8.1 
Biometrical aspects of trial design ........................................................................................ 33 
8.2 
Measures against Bias ........................................................................................................... 33 
8.3 
Primary Endpoint ................................................................................................................... 33 
8.4 
Secondary endpoints ............................................................................................................. 33 
8.5 
Sample size calculation .......................................................................................................... 33 
8.6 
Analysis population ............................................................................................................... 34 
8.7 
Subgroups .............................................................................................................................. 34 
8.8 
Statistical Analysis ................................................................................................................. 34 
8.9 
Handling of missing data ....................................................................................................... 35 
8.10 
Interim analysis ..................................................................................................................... 35 
8.11 
Final analysis .......................................................................................................................... 35 
9. 
Safety and Event Handling ............................................................................................................ 36 
9.1. 
Definitions ............................................................................................................................. 36 
9.2. 
Documentation of AEs/SAEs, device deficiencies and (serious) incidents ............................ 37 
10. Monitoring .................................................................................................................................... 40 
11. Deviations from the study investigation plan............................................................................... 41 
11.1 
Major deviations.................................................................................................................... 41 
12. Regulatory and Ethical Considerations ......................................................................................... 42 
13. Study Report and Publication Policy ............................................................................................. 43 
14. Contact Information ..................................................................................................................... 44 
15. References and appropriate standards ........................................................................................ 45 
 
 
 

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List of Abbreviations 
ABPI 
Ankle brachial pressure index 
ADE 
Adverse device effect 
AE 
Adverse event 
BC 
Bacterial cellulose 
CDC 
Centres for Disease Control and Prevention 
e-CRF 
Electronic Case report form 
FAS 
Full analysis set 
ICF 
Informed consent from 
IFU 
Instruction for use 
NRS 
Numeric rating scale 
PMCF 
Post-market Clinical Follow-up 
PPS 
Per protocol set 
PHMB 
Polyhexamethylene biguanide, Polyhexanide  
QoL 
Quality of Life 
SADE 
Serious adverse device effect 
SAE 
Serious adverse event 
SAP 
Statistical Analysis Plan 
SAS 
Safety analysis set 
TILI 
Therapeutical Index for Local Infections 
VLU 
Venous leg ulcer 
 
 
 

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2. Synopsis 
Name of the 
sponsor 
Lohmann & Rauscher GmbH & Co. KG 
Title of the study 
Multicentre, randomised in parallel groups, controlled study to compare per-
formance and safety of Suprasorb® X+PHMB Pro with Suprasorb® X+PHMB 
dressing in treatment of infected venous leg ulcers 
Protocol number 
2024-07 
Version and date 
Version 1.1, 14 Aug 2025 
Study description 
This clinical investigation will be conducted as a multicentre, open-label, ran-
domised in parallel groups, controlled study on patients with infected venous 
leg ulcers. 
During the screening, all patients will be assessed for inclusion and exclusion 
criteria and wound exudation status. Eligible patients with slight or moderate 
wound exudation will be randomly assigned to treatment with either Supra-
sorb®X+PHMB Pro or Suprasorb®X+PHMB.  
The patients who fulfil all other eligibility criteria but have high level of wound 
exudation will enter a 7-days run-in period, during which they will receive su-
perabsorbent dressing (e.g. Vliwazell® Pro, Vliwasorb® Pro) and monitored com-
pression therapy with Rosidal® 1C. During the run-in period they should receive 
appropriate treatment including systemic antimicrobial drug therapy if re-
quired. After this time, these patients should be re-assessed and in case they 
still fulfil all eligibility criteria, and the exudation decreased at least to a mod-
erate level, they will be randomised to Suprasorb®X+PHMB Pro or Supra-
sorb®X+PHMB. In case the exudation would not decrease within this period or 
other eligibility criteria are not met anymore, they will be screened out. 
Day -7 
 
Screening  
infection, exu-
dation status 
 
 
 
↙ 
 
↘ 
 
 
Slight to moder-
ate exudation  
 
High exudation 
 
 
 
↓ 
 
Run-in 7 days 
Exudation and infection re-as-
sessment 
 
↓ 
↓ 
 
Slight to moder-
ate exudation  
High exuda-
tion and / or 
no more infec-
tion signs 
 
↓ 
↓ 
Day 0 
Randomisation 
Screen-out 
 
↙ 
 
↘ 
 
Day 10 
Supra-
sorb®X+PHMB Pro 
Treatment 3 
weeks,  
interim control 
Supra-
sorb®X+PHMB 
 
 
↓ 
 
↓ 
 
Day 21 (±2) 
Final assessment 
 

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Upon randomisation, all patients will receive the assigned dressing for 21 (±2) 
days, or till the complete epithelialization, if it occurs earlier. The patients 
should also continue to receive adequate compression and, if necessary, sys-
temic antimicrobial drug therapy.   
During the study participation, selected parameters of the wound will be as-
sessed at Baseline, Interim Visit, and EOT visit. In addition, dressing changes 
may be performed in-between on as needed basis.   
After 3 weeks of treatment with Suprasorb®X+PHMB Pro or Supra-
sorb®X+PHMB, all patients will complete the study. Their further treatment (if 
necessary), will not be the part of the study.  
Objectives 
Evaluation of performance and safety of Suprasorb®X+PHMB Pro in the treat-
ment of infected venous leg ulcers in comparison to Suprasorb®X+PHMB. 
Endpoints 
Primary endpoint: 
Rate and severity of maceration after 3 weeks of treatment with 
Suprasorb®X+PHMB (Pro) (by the investigators’ assessment as well as by an 
independent assessment of the wound photos) 
Secondary endpoints:  
− Wound area changes over time (by the investigators’ assessment as well 
as by an independent assessment of the wound photos) 
− Change of necrotic & fibrinous / granulation tissue rate in the wound 
bed (by an independent assessment of the wound photos) 
− Change of wound infection status during the study (by a modified CDC 
definition, confirmed by a TILI score) 
− Product safety (assessed by rate of product-related complications)  
− Change of wound exudation and presence of peri-wound oedema (by 
the investigators’ assessment) 
− Change in patient’s pain (measured by NRS scale)  
− Product usability (assessed by means of user and patient questionnaire 
for both Suprasorb®X+PHMB (Pro) and Rosidal 1C) 
− Change in patient’s quality of life (assessed by means of Wound QoL-17 
scale) 
− Oedema reduction (by measurement of limb circumference) 
− Sub-bandage pressure levels retention (difference of the pressure levels, 
measured at the time of application and before the next dressing 
change)  
Study population 
Adult patients with infected venous leg ulcer.  
150 patients will be randomised in the study (75 in each group), a drop-out 
rate of 5% is expected. To get this number, screening and inclusion of up to 
200 patients is planned. 
Study phase 
IV (Post-marketing surveillance) 

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Study centres 
6-8 sites in Poland 
Study duration 
Set up and preparation 3 months, recruitment 12 months, treatment 1 month, 
study closure and data analysis 9 months. Overall duration 24 months. 
Participation 
duration 
Each patient will participate for at least 21 (±2) days, or till the complete epi-
thelialization, if it occurs earlier. In case a run-in period is necessary for a pa-
tient, maximal participation time will be 28 (±2) days.  
Interim analysis 
Planned upon randomisation of 75 patients (50% of the study population) 
Inclusion criteria 
− Age ≥ 18 years 
− Infected* venous** leg ulcer 
− Slightly to moderately exuding wound*** 
− Patient has signed informed consent 
* as per CDC definition, also TILI score ≥ 5 (see section 5.4.1) 
** ABPI > 0.8 and < 1.2 (see section 5.4.2) 
*** patients with highly exuding wounds may be screened for a 7 days run-in period 
to receive superabsorbent dressing and monitored compression therapy and re-con-
sidered for enrolment in case the exudation level decreases (see section 5.4.3) 
Exclusion criteria 
− Participation in other interventional clinical trial that could interfere 
with the present study within 4 weeks of the randomisation and during 
the whole duration of this study  
− Wounds with exposed cartilage tissue (hyaline cartilage) 
− Contraindications to compression therapy (e.g.: advanced peripheral ar-
terial occlusive diseases, decompensated cardiac insufficiency, septic 
phlebitis, phlegmasia coerulea dolens, sensation disorders of the skin) 
− Known allergy and/or hypersensitivity to any components of the study 
product or concomitant products (e.g. compression bandage) 
− Any other medical condition, which, by opinion of the investigator, may 
have impact of the success of the study treatment and / or interpreta-
tion of the study results. 
Statistical 
methods 
Study will be descriptive in nature. Outcome measures will be summarized us-
ing descriptive statistics by study arm, no formal comparisons between study 
arms will be performed. In assessment of primary endpoint (maceration at end 
of treatment, measured on 4-point scale) percentage of patients with macera-
tion at each of 4 levels of the scale will be reported, by study arm, with corre-
sponding two-sided 95% confidence intervals. 
A level of statistical significance alpha is set at 0.05, what corresponds to the 
two-sided 95% confidence intervals. 
Sample size 
calculation 
Enrolment of 150 patients, under assumption of 5% drop-out rate, will allow 
to estimate the percentage of patients with selected level of maceration at the 
end of treatment by the study arm with precision equal or greater (i.e. width 
of 95% confidence interval less than or equal to) 24 percentage points for 

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percentage of 50% and increasing (i.e. decreasing width of 95% confidence in-
terval) for percentages lower than and higher than 50%. 
Insurance 
Sponsor of the study will take over the insurance in accordance with the Polish 
Law. 
Ethical 
considerations 
Approval of the Ethics Committee(s) and the Regulatory Authority of Poland 
will be obtained before the study start. 
 
 

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3. Introduction and Justification 
3.1 
Medical and scientific background 
Production of bacterial cellulose (BC) for the specific purpose of wound dressing dates back to the early 
1980s. BC is a polymer produced by several bacteria species and its unique mechanical characteristic 
is a high surface area, which provides a great liquid loading capacity: water absorbency of BC was found 
to be more than 30% greater than for cotton gauze, and the drying time 33% longer.1 BC also demon-
strates high tensile strength, flexibility, pronounced permeability to gases and liquids, and a good skin 
compatibility.1-4 
BC itself does not have antimicrobial properties to prevent infection in-growth and represents just a 
physical barrier against bacterial invention. One of the most actively utilized approaches used to intro-
duce antimicrobial properties is impregnation of the BC with polyhexamethylene biguanide (PHMB).1 
PHMB is effective in both decreasing bacterial load and preventing bacterial penetration of the dress-
ing, has low toxicity to human tissue and does not promote bacterial resistance.5-7 
Suprasorb® X+PHMB Pro Antimicrobial HydroBalance wound dressing and its predecessor Suprasorb® 
X+PHMB Antimicrobial HydroBalance wound dressing are representatives of PHMB-impregnated BC 
dressings. Both dressings consist of cellulose, water and 0.3% polyhexamethylene biguanide 
(PHMB/polyhexanide), and the only difference is that the new (Pro) version is covered by a blue per-
forated polyethylene film on the side facing away from the wound, which acts as a moisture barrier 
during use and significantly slows down the evaporation of the fluid in comparison to the previous 
dressing version. This additional measure was intended to reduce the risk of wound dressing drying-
out and attachment to the wound bed, which might cause wound bed injury by the dressing change. 
In the same time, it may be debated, if such change in the fluid management might potentially increase 
the risk of maceration. Possible effect of this difference on the maceration rate will be the main area 
of investigation within this clinical study. 
3.2 
Current clinical and preclinical data for both products 
Suprasorb® X+PHMB Antimicrobial HydroBalance wound dressing and packing rope has been on a mar-
ket since 2006 and demonstrated acceptable safety profile, also regarding maceration. Lenselink and 
Andriessen8 do not report any cases of maceration for their cohort study of Suprasorb X+PHMB for the 
eradication of biofilms in non-healing wounds (28 adult patients suffering from non-healing locally in-
fected and/or critically colonised wounds of various aetiologies. Eberlein and al.9 compared treatment 
with Suprasorb X+PHMB versus silver dressings in patients with painful, critically colonised (wound-at-
risk) or locally infected wounds (38 adult patients) and observed slight maceration in the Supra-
sorb®X+PHMB group at day 7 (mean score=1.2), which decreased during the study period to a mean 
score of 0.8 by day 28. Wild et al.10 do not report cases of maceration in their study comparing Poly-
hexanide-Containing Cellulose Dressing (Suprasorb X+PHMB) with Polyhexanide Swabs in Eradication 
of Methicillin-Resistant Staphylococcus aureus in pressure ulcers; however, authors make a statement 
that “with the use of the HydroBalance dressing, changes to the wound edges may occur, which may 
be misinterpreted as maceration by less experienced clinicians. These whitish coatings on the peri-
wound skin, however, can be easily removed by gentle wiping with a moist swab. Underneath it, the 
epidermis is intact and appears to be soft and more delicate as compared with the patient’s normal 

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skin (the ‘‘wipe’’ or ‘‘wave’’ effect). Therefore, effective monitoring of the wound bed evolution and 
peri-wound skin condition is required.” In the study by Nielsen and Andriessen11 comparing Suprasorb 
X+PHMB and hydrophobic dressing with dialkylcarbamoyl-chloride (60 adult patients with surgical 
wounds healing by secondary intention), maceration of the peri-wound skin occurred by only 6% 
(n=2/30) patients in Suprasorb X+PHMB group vs 17% (n = 5/30) patients in comparator group.  
Suprasorb X+PHMB Pro is not yet on the market but has been CE marked since 2018 and clinical data 
has been collected in the course of the pilot PMCF study12 that has been conducted in 2019 / 2020 and 
an observational, international, multi-centric, 1-arm marketing study.13 
- 
Pilot PMCF study: the acceptance criterion ‘vital without maceration for more than 75%’ was 
met; namely, 90.6% of the wounds demonstrated absence of maceration at V2. Only 5 cases 
of newly occurred maceration were recorded in the study totally by investigators and inde-
pendent reviewer (the cases did not match), with 4 cases in the diabetic ulcer group and one 
case in the VLU group (rate 1/18 = 0,06). 
- 
Observational, international, multi-centric, 1-arm marketing study: regarding maceration, 
mostly positive answers were received for retrospective comparison of Suprasorb X+PHMB 
Pro with Suprasorb X+PHMB (7 users were interviewed): 
 
Much better  
Better 
Similar 
Worse 
Much worse 
Prevention of maceration 
2  
2 
1 
2 
0 
It appears that the risk of maceration of the peri-wound skin after use of Suprasorb X+PHMB Pro is not 
significantly different to that of Suprasorb X+PHMB. However, both studies involved only a limited 
population which does not allow to collect a statistically significant information, thus more investiga-
tion in clinical setting is necessary. 
3.3 
Justification of the study design  
3.3.1 Primary study endpoint and selection of comparator 
Due to the outer blue film of Suprasorb X+PHMB Pro dressing the drying of the product is slowed by a 
factor 10 in comparison to Suprasorb X+PHMB wound dressing. This additional measure was intended 
to reduce the risk of wound dressing drying-out and attachment to the wound bed, which might cause 
wound bed injury by the dressing change. In the same time, it may be debated, if such change in the 
fluid management might potentially increase the risk of maceration. Thus, this study was planned to 
investigate the performance and safety of Suprasorb®X+PHMB Pro, with a specific focus on the peri-
wound skin maceration (both rate and severity of maceration will be evaluated). 
Randomised controlled trial (RCT) design was selected as it represents the current standard of quality 
for the clinical trials, with randomisation allowing to reduce bias and to balance characteristics of the 
patients in the intervention and the control groups.14-16  
Since the main focus of the study is the maceration risk change, which might be connected to the 
design change in comparison with the predecessor product Suprasorb®X+PHMB, the latter  was se-
lected as a comparator (control group). 
 
 

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3.3.2 Target study population 
Venous leg ulcer (VLU) is the most common type of chronic wound.17 The Society for Vascular Surgery 
and the American Venous Forum defines VLU as an open skin lesion of the leg or foot that occurs in an 
area affected by venous hypertension.18 VLUs are caused by sustained venous hypertension, which 
results from chronic venous insufficiency or an impaired calf muscle pump. Risk factors include obesity, 
immobility, varicose veins, and deep vein thrombosis.19, 20 Venous leg ulcers can also occur spontane-
ously or after minor trauma.21 
Most venous leg ulcers produce large amounts of exudate. This fluid contains high concentrations of 
proteases and inflammatory cytokines that may damage surrounding healthy skin. Removal of wound 
drainage from the wound bed will reduce the inflammatory environment that prohibits wound healing. 
Even if there is insufficient evidence suggesting that a specific primary dressing that contacts the 
wound can result in a higher rate of wound closure, the Clinical Practice guidelines of the Society for 
Vascular Surgery and the American Venous Forum recommend use of dressings that will manage 
wound exudate and maintain a moist wound bed at the same time.18 Primary dressings with high ab-
sorptive capabilities, including foams, alginates, and other specialty dressings, are often selected for 
the primary coverage layer for heavily exudative VLUs.18 PHMB-impregnated BC dressings, such as Su-
prasorb X+PHMB (Pro) may also be recommended for treatment of VLUs since they can help managing 
wound exudate and decrease bacterial load at the same time. 
Infected venous leg ulcer was selected as a target group for the study, since a) VLU is an indication 
prone to maceration due to generally high exudation level, especially if they are infected, and b) VLU 
is the most common type of chronic wound and thus the evidence collected on this etiology is of a 
great importance for the healthcare16. 
3.3.3 Secondary study endpoints and treatment duration 
Twenty one day (3 weeks ±2 days window for possible logistic adjustments) seems to be enough to 
detect appearance and grade of maceration which may be reliably attributed to the use of the study 
dressing or comparator. Additional run-in period of seven days may be implemented for the patients 
with high levels of wound exudation to minimise the exudation and oedema levels. During this period, 
the patients will not receive the investigative product or comparator, but a superabsorbent dressing 
(e.g. Vliwazell® Pro, Vliwasorb® Pro) and monitored compression therapy with Rosidal® 1C. 
It is generally not expected that venous leg ulcer will heal within 3 weeks. In the retrospective study of 
Läuchli et al.22 healing rate, assessed for 355 patients with VLU composed 45.5% and 63.0% after 3 and 
6 months, respectively. Kruszewska et al.23 analysed the average ulcer healing time for 30 patients with 
VLU receiving antibiotic therapy, and it consisted 163.4 ± 97.1 (range 51.0 to 426.0) days and increased 
by 28 days with each additional bacterial strain in the ulcer (p = 0.041). Thus, in this study the wound 
area change will be assessed as a secondary endpoint, which, however, in combination with the level 
of pain and wound-related quality of life may represent an important patient-relevant benefit of the 
treatment.16 

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3.4 
Study related risks 
During the study participation the patients will be treated with CE-certified products within the in-
tended purpose in both treatment arms. Also, only CE-certified products will be used as additional 
measures. Therefore, no additional study-related risks are expected for the participating patients.  
3.5 
Benefit-risk ratio of the study 
All known potential risks that may occur during the study have been assessed. Suprasorb® X+PHMB 
Antimicrobial HydroBalance wound dressing and packing rope has been on a market since 2006 and 
demonstrated acceptable safety profile. Suprasorb® X+PHMB Pro is not yet on the market but has been 
CE marked since 2018. Clinical safety data on Suprasorb® X+PHMB Pro have been generated and are 
held by the manufacturer as part of a PMCF study, an observational study as well as usability (ac-
ceptance) tests. Also, PHMB-containing biocellulose dressings in general are clinically well-established 
dressings for infected wounds. 
The study will not require any additional invasive tests or procedures, compared to the ones the pa-
tients would normally receive. There will be additional burdensome but non-invasive procedures: like 
continuous pressure measurement with a wireless pressure sensor; photographic wound documenta-
tion; completion of paper scales / wound questionnaires. In rare cases, continuous pressure measure-
ment might cause non-severe and reversible skin irritation, local discomfort and / or pain. Other two 
procedures do not pose any additional risk to patients’ health. Therefore, the benefit / risk ratio for 
this study may be assessed as positive. 

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4. Study devices 
4.1 
Suprasorb® X+PHMB Pro Antimicrobial HydroBalance wound dressings/ packing rope 
Suprasorb® X+PHMB Pro Antimicrobial HydroBalance wound dressings consist of cellulose, water and 
0.3% polyhexamethylene biguanide (PHMB/polyhexanide) and on the side facing away from the 
wound is covered by a blue perforated polyethylene film, which acts as a moisture barrier during use. 
Suprasorb® X+PHMB Pro Antimicrobial HydroBalance packing rope consists of cellulose, water and 
0.3% polyhexamethylene biguanide (PHMB/polyhexanide). Both dressing and rope are additionally 
covered by arrow-printed release film made of PP. This protective sheet should be peeled off prior to 
the use of the devices. 
The product is available in different sizes (5 × 5 cm, 9 × 9 cm, and 14 × 20 cm for the dressing, 2 × 21 
cm for the rope), and can be additionally cut to size. 
Due to the porous structure of the biocellulose and the content of water, Suprasorb X+PHMB Pro can 
absorb exudate and donate moisture. The principle of action of the HydroBalance effect is exchange 
of moisture: when the wound contains more moisture than the wound dressing, moisture migrates 
into the dressing. When there is more moisture in the wound dressing than in the wound (low level of 
exudation) the wound dressing can donate moisture to the wound. Water evaporates from the wound 
dressing into the surrounding air. The HydroBalance effect is therefore limited. Due to the outer blue 
film of Suprasorb X+PHMB Pro dressing the drying of the product is slowed by a factor 10 in comparison 
to Suprasorb X+PHMB wound dressing (predecessor product).  
In addition to this PHMB inhibits microbial activity through specifically destroying bacterial cell mem-
branes. Thus Suprasorb® X+PHMB Pro Antimicrobial HydroBalance wound dressings / packing rope 
have an antimicrobial effect against a broad spectrum of pathogens (see Table 1). A very rapid and 
almost complete release of polyhexanide (PHMB) from the dressing after 24 h has been demonstrated 
in vitro.  
Table 1: Pathogen spectrum detected in vitro 
Bacteria 
Fungi 
Anaerobe Organism 
Bacillus subtillis 
Aspergillus niger 
Bacteroides fragilis 
Enterobacter cloacae 
Trichophyton mentagrophytes 
Clostridium perfringens 
Proteus vulgaris 
Yeasts 
Peptostreptococcus prevotii 
Pseudomonas aeruginosa 
Candida albicans 
 
Pseudomonas putida 
Rhodotorula rubra 
 
Salmonella choleraesius 
Saccharomyces cerevisiae 
 
Salmonella Typhimurium 
 
 
Staphylococcus aureus 
 
 
Staphylococcus aureus (MRSA) 
 
 
Enterococcus faecalis (VRE) 
 
 
Streptococcus lactis  
 
 
Escherichia coli 
 
 
Klebsiella pneumoniae 
 
 
Proteus mirabilis 
 
 
Serratia marcescens 
 
 
Staphylococcus epidermis 
 
 
Streptococcus pyogenes 
 
 

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Changing the dressing is atraumatic. The material makes it easy to conform to the wound’s particular 
shape and depth. The products are therefore especially suitable for areas of the body which are diffi-
cult to dress. The positive properties of the dressing resist adhesion to the wound or to the secondary 
dressing. The moist environment with a cooling effect is perceived by patients as pleasant and pain-
relieving. 
The products are packed individually and sterilised by irradiation. 
Intended purpose 
Antimicrobial HydroBalance Bio-Cellulose wound dressings / packing rope aid wound healing by do-
nating moisture and absorbing exudate from lightly to moderately exuding superficial or deep, infected 
wounds or wounds at risk of infection, inhibiting microbial activity. 
Indications 
Suprasorb® X+PHMB Pro Antimicrobial HydroBalance wound dressings / packing rope are suitable for: 
• 
arterial and venous ulcers 
• 
diabetic ulcers 
• 
pressure sores  
• 
superficial 2nd degree burns 
• 
postoperative surgical wounds 
• 
skin grafts 
• 
skin graft donor sites 
• 
abrasions, lacerations 
Contraindications 
• 
3rd degree burns  
• 
wounds with exposed cartilage tissue (hyaline cartilage) 
• 
known allergy and/or hypersensitivity to any of the product components 
Side effects: 
In very rare cases skin irritations and/or allergies may occur. 
Isolated cases of anaphylactic shock or pain at the beginning of treatment have been described.  
Warnings and precautions  
Do not use if package is damaged or accidentally opened. 
The continuation of treatment must be decided upon by a healthcare professional if any of the follow-
ing symptoms should occur:  
• change in colour and/ or odour of the wound 
• stagnant wound healing 
• clinical signs of infection 
When treating infected wounds, the wound dressing should not be the only therapeutic measure used, 
but rather should be supplemented by drug therapy at the discretion of the treating physician in ac-
cordance with local clinical protocols. 

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Note that there might be interactions between cationic PHMB and anionic hyaluronic acid, as well as 
other anionic products, as the antimicrobial effect of the PHMB can be reduced by the binding of the 
ions. 
Application during pregnancy, on breastfeeding women, and children up to two years of age is decided 
on by the treating physician. However, this is not recommended, as no documented clinical experience 
with the product in such cases is available.  
Manufacturer 
Lohmann & Rauscher International GmbH & Co. KG 
Westerwaldstrase 4, 56579 Rengsdorf, Germany 
4.2 
Reference therapy 
Suprasorb® X+PHMB Antimicrobial HydroBalance wound dressing and packing rope (predecessor prod-
ucts) will be used as a reference therapy. The only difference between the two dressings is that the 
new (Pro) wound dressing is covered by a blue perforated polyethylene film on the side facing away 
from the wound, which acts as a moisture barrier during use. Suprasorb® X+PHMB Pro Antimicrobial 
HydroBalance packing rope and Suprasorb® X+PHMB Antimicrobial HydroBalance packing rope (pre-
decessor) are fully identical.  
According to MDCG 2020-5 Suprasorb® X+PHMB Pro can be considered equivalent to Suprasorb 
X+PHMB regarding clinical, biological, and technical parameters. The main performance characteristics 
of the new (Pro) dressing are comparable to the predecessor product, with the exception of the drying 
out, which is slowed in Suprasorb X+PHMB Pro wound dressing by a factor 10 in comparison to Supra-
sorb X+PHMB wound dressing due to presence of the outer PE film. Possible effect of this difference 
of the change of maceration rate will be the main area of investigation within this clinical study. 
Manufacturer 
Lohmann & Rauscher International GmbH & Co. KG 
Westerwaldstrase 4, 56579 Rengsdorf, Germany 
4.3 
Additional measures  
Both Suprasorb® X+PHMB Pro and Suprasorb® X+PHMB should be additionally secured in place. The 
following options are proposed in the IFU of the products: 
Suprasorb® X+PHMB Pro:24 
“Secure the wound dressing with a suitable secondary dressing (Suprasorb® F film dressing, Curapor® 
sterile surgical wound dressing). For patients with lightly exuding wounds, other types of secondary 
dressings are not recommended (risk of drying out). For patients with moderately exuding wounds and 
a high risk of maceration, other types of secondary dressings (Suprasorb® P sensitive border foam 
dressing) should be used. Protruding edges in the combined dressing (blue perforated film and wound 
dressing) are not a matter for concern. The size of the secondary dressing should be big enough to 
overlap the wound dressing.” 
Suprasorb® X+PHMB:25 
“Secure with a suitable secondary dressing (Suprasorb® F film dressing, Suprasorb® P foam dressing).” 

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In addition, for both products controlled compression should be applied. Compression therapy is the 
most widely used treatment for venous leg ulcer.26 Compression applied to the calf raises the local 
interstitial pressure and decreases the superficial venous pressure, thereby reducing the leak of solutes 
and fluid into the interstitial space. It also improves the venous return, which leads to decrease in 
venous hypertension and subsequently potentiates healing process.27, 28, 29 According to Okan et al.,30 
clinicians must always remember to remove the causes of increased production of exudate through 
compression and elevation for venous and lymphoedematous leg ulcers.  
Compression therapy (preferably multilayer) is directly recommended by the Society for Vascular Sur-
gery and the American Venous Forum (SVS-AVF)31 (See Table 2).  
Table 2: Recommendations of Society for Vascular Surgery and the American Venous Forum for com-
pression therapy by VLU 
Treatment modality – compression therapy 
SVS-AVF 
guideline 
recommendation 
Compression therapy recommended over no compression in active VLU 
GRADE 1A 
Compression therapy to prevent recurrence in those with healed VLU 
GRADE 2B 
Multi-component or multilayer compression recommended over the use of 
single-component bandage for the treatment of active VLU 
GRADE 2B 
To unify the impact of compression on the study results, similar compression regime should be used 
for all study patients. One-component short-stretch bandage Rosidal® 1C should be used in combina-
tion with multi-point wireless pressure sensor (MPS) which allows to measure and control sub-band-
age pressure during and after application.  
Rosidal 1C bandage is a one-component system which includes short-stretch compression side and a 
soft side for padding. The bandage has a cross-elasticity of approx. 50%, which allows a comfortable 
application around joints, and a maximum lengthwise elongation of 100%, which ensures desired com-
pression without a risk of excessive pressure ("safe-loc system"). For the application technique, please 
refer to the Instruction for use.32 Recommended pressure levels at measurement point B1 (approxi-
mately 10 cm above the inner ankle, where the tendon merges into the calf muscle) lay between 40 
and 60 mmHg.33  
To additionally control the level of sub-bandage pressure, a small portable device (Tight Alright) will 
be used. Device consists of a pressure sensor and a battery-powered transmitter which wirelessly 
transfer the pressure data to a special software. The device should be applied above a non-compres-
sive stockinette and appropriate padding, fixed by the included adhesive sheath, and then covered by 
the compression bandage. It should stay in place till the next dressing change or compression bandage 
adjustment. For the application technique, please refer to the Instruction for use.34 
Systemic antimicrobial drug therapy is generally used by treatment of the infected VLUs.23, 35 The se-
lection of the exact treatment scheme should be done at the discretion of the treating physician in 
accordance with the local clinical protocols. 
 
 

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5. Study Details 
5.1 Study Design 
This clinical investigation will be conducted as a multicentre, randomised in parallel groups, controlled 
study on patients with infected venous leg ulcer.  
During the screening, all patients will be assessed for inclusion and exclusion criteria and wound exu-
dation status. Eligible patients with slight or moderate wound exudation will be randomly assigned to 
treatment with either Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB.  
The patients who fulfil all eligibility criteria but have high level of wound exudation will enter a 7-days 
run-in period, during which they will receive superabsorbent dressing (e.g. Vliwazell® Pro, Vliwasorb® 
Pro) and monitored compression therapy with Rosidal® 1C. During the run-in period patients with in-
fected venous leg ulcers should receive appropriate treatment including systemic antimicrobial drug 
therapy if required. After this time, these patients should be re-assessed and in case they still fulfil all 
eligibility criteria, and the exudation decreased at least to a moderate level, they will be randomised 
to Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB. In case the exudation would not decrease within 
this period or other eligibility criteria are not met anymore, they will be screened out. 
Day -7 
 
Screening 
infection, exudation 
status 
 
 
 
↙ 
 
↘ 
 
 
Slight to moderate 
exudation 
 
High exudation 
 
 
↓ 
 
Run-in 7 days 
Exudation and infection re-assessment 
 
↓ 
↓ 
 
Slight to moderate 
exudation 
High exudation and / 
or no more infection 
signs 
 
↓ 
↓ 
Day 0 
Randomisation 
Screen-out 
 
↙ 
 
↘ 
 
Day 10 
Suprasorb®X+PHMB 
Pro 
Treatment 3 weeks, 
interim control 
Suprasorb®X+PHMB 
 
 
↓ 
 
↓ 
 
Day 21 (±2) 
Final assessment 
 
Upon randomisation, all patients will receive the assigned dressing for 21 (±2) days, or till the complete 
epithelialization, if it occurs earlier. The patients should also continue to receive adequate compression 
and, if necessary, systemic antimicrobial drug therapy.   
During the study participation, selected parameters of the wound will be assessed at Baseline, Interim 
Visit, and EOT visit. In addition, dressing changes may be performed in-between on as needed basis.   
After 3 weeks of treatment with Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB, all patients will com-
plete the study. Their further treatment (if necessary), will not be a part of the study. 

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5.2 Study endpoints 
5.2.1 Primary endpoint  
− Rate and severity of maceration during 3 weeks of treatment with Suprasorb®X+PHMB 
(Pro) (by the investigators’ assessment as well as by an independent assessment of the 
wound photos) 
5.2.2 Secondary endpoints  
− Wound area change over time (by the investigators’ assessment as well as by an inde-
pendent assessment of the wound photos) 
− Change of necrotic & fibrinous / granulation tissue rate in the wound bed (by an inde-
pendent assessment of the wound photos) 
− Change of wound infection status during the study (by CDC definition and a TILI score) 
− Product safety (assessed by rate of product-related complications) 
− Change of wound exudation and presence of peri-wound oedema (by the investiga-
tors’ assessment) 
− Change in patients’ pain (measured by NRS scale) 
− Product usability (assessed by means of user and patient questionnaire for both Su-
prasorb®X+PHMB (Pro) and Rosidal 1C) 
− Change in patient’s quality of life (assessed by means of Wound QoL-17 scale) 
− Oedema reduction (by measurement of limb circumference) 
− Sub-bandage pressure levels retention (difference of the pressure levels, measured at 
the time of application and before the next dressing change) 
5.3 
Study Population 
Adult patients with infected venous leg ulcer. 150 patients will be included in the study (75 in each 
group), a drop-out rate of 5% is expected. To get this number, screening and inclusion of up to 200 
patients is planned. 
5.3.1 Inclusion criteria 
− Age ≥ 18 years 
− Infected* venous** leg ulcer 
− Slightly to moderately exuding wound*** 
− Patient has signed informed consent 
* as per CDC definition, also TILI score ≥ 5 (see section 5.4.1) 
** ABPI > 0.8 and < 1.2 (see section 5.4.2) 

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*** patients with highly exuding wounds may be screened for a 7 days run-in period to receive superabsor-
bent dressing and monitored compression therapy and re-considered for enrolment in case the exudation 
level decreases (see section 5.4.3) 
5.3.2 Exclusion criteria 
− Participation in other interventional clinical trial that could interfere with the present 
study within 4 weeks of the randomisation and during the whole duration of this study 
− Wounds with exposed cartilage tissue (hyaline cartilage) 
− 
Contraindications to compression therapy (e.g., advanced peripheral arterial occlusive 
diseases, decompensated cardiac insufficiency, septic phlebitis, phlegmasia coerulea 
dolens, sensation disorders of the skin) 
− Known allergy and/ or hypersensitivity to any of the study product or concomitant 
products (e.g. compression bandage) components 
− Any other medical condition, which, by opinion of the investigator, may have impact 
of the success of the study treatment and / or interpretation of the study results. 
5.4 
Study methods 
5.4.1 Modified CDC definition and TILI Score 
To confirm the infection status of the wounds and its’ change during the study, modified CDC SSI cri-
teria,36 confirmed by a TILI score,37, 16 will be used.  
Modification of the criteria implied exclusion of the “time after operative procedure” criteria since it 
is not relevant for the chronic wound, and change of the term “incision” to the term “wound”. Other-
wise, the criteria remained unchanged. To be included in the study, the patient /wound has to demon-
strate at least one of the following criteria:  
- a. purulent drainage from the wound;  
- b. organism(s) identified from an aseptically-obtained specimen from the superficial 
incision or subcutaneous tissue by a culture or nonculture based microbiologic testing 
method which is performed for purposes of clinical diagnosis or treatment (for example, 
not Active Surveillance Culture/Testing [ASC/AST])  
- c. if culture or non-culture based testing of the superficial incision or subcutaneous 
tissue is not performed: patient has at least one of the following signs or symptoms: lo-
calized pain or tenderness; localized swelling; erythema; or heat  
- d. diagnosis of a wound infection is confirmed by a physician or physician designee 
Moreover, the infection should be confirmed by the TILI (Therapeutical Index for Local Infections) 
score, which is an objective scale considering six indirect signs of local wound infection:  
- erythema to surrounding skin,  
- heat,  
- oedema, induration or swelling, 

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- spontaneous pain or pressure pain, 
- stalled wound healing, 
- increase and/ or change in colour or smell of exudate. 
Each parameter costs 1 point and the score is a sum of the present points. TILI < 5 indicates a wound 
without infection, whereas TILI ≥ 5 means a local wound infection. 
5.4.2 Grade of wound exudate 
Suprasorb®X+PHMB (Pro) is intended for wounds with light to moderate exudation level. For the exu-
dation grade, the following definition from the WUWHS Consensus Document38 should be followed: 
- 
None: Wound tissues are dry 
- 
Light: Wound tissues are moist; no measurable exudate 
- 
Moderate: Wound tissues are wet; moisture evenly distributed in wound; drainage 
involves <25% dressing 
- 
High: Wound tissues are saturated; drainage may or may not be evenly distributed in 
the wound; the drainage involves > 25% to <75% dressing 
- 
Very high: Wound tissues are bathing in fluid; drainage freely expressed; may or may 
not be evenly distributed in wound; drainage involves > 75% of dressing. 
5.4.3 
Assessment of vascular status 
Before inclusion in the study, vascular status should be assessed by determination of the Anke Brachial 
Pressure Index (ABPI) which is the quotient of the highest blood pressure in the foot on which the 
ulceration exists divided by the highest blood pressure on any arm. Only patients with an ABPI > 0.8 
and < 1.2 can be enrolled into the study.  
5.4.4 Maceration score 
Maceration score, proposed by Dini et al.39 will be used in the study. This scoring system is based on 
the clinical degree of skin whiteness/redness and the numerical value of area involved in surrounding 
skin to the ulcer evaluated: 
Clinical score 
Degree of Surrounding Skin maceration, area, cm2  
0=absent 
0 
1=minimal 
< 0,5 
2=moderate 
0,5 - 2 
3=severe 
> 2 
This scoring will be done by the investigators and also confirmed by an independent review of the 
wound photos. 

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5.4.5 NRS  
NRS (numeric rating scale) is a pain screening tool, commonly used to assess pain severity at that mo-
ment in time using a 0–10 scale, with zero meaning “no pain” and 10 meaning “the worst pain imagi-
nable”.  
According to Breivik at al.,40 the NRS and the VAS have been shown to give almost identical values in 
the same patient at various times after surgery, whereas NRS is more practical than a VAS, easier to 
understand for most people, and does not need clear vision, dexterity, paper, and pen. 
5.4.6 Wound-QoL-17 
The Wound-QoL-17 is a clinical tool, which allows to measure the disease-specific, health-related qual-
ity of life (HRQoL) of patients with chronic wounds.41 It was developed on the basis of three validated 
instruments assessing HRQoL in chronic wounds: the Freiburg Life Quality Assessment for wounds 
(FLQA-w),42 the Cardiff Wound Impact Schedule (CWIS),43 and the Würzburg Wound Score (WWS).44 
The Wound-QoL is filled in by the patients themselves. The questionnaire is self-explanatory; yet, pa-
tients can be supported if they are not able to fill it in by themselves. In this case, the support has to 
be documented.  
Validated translation of the Wound-QoL-17 in Polish will be used within this study. 
5.4.7 Wound Photos 
As the wound photos will be used for an independent assessment of the primary endpoint, as well as 
for the assessment of some secondary endpoints, their appropriate quality is crucial. The following 
rules should be considered by taking the wound photos for the study: 
- photos are taken without wound dressing, after the wound cleaning, if necessary, but 
before debridement,  
- uniform, bright illumination is necessary (flash may be used in case of insufficient room 
illumination, but there should be no glare on the photo), 
- wound should cover at least 1/3 of the picture, pictures from the same wound should 
be done from the same angle, 
- single use paper-based wound ruler should be present on every picture, it has to be 
placed on the same level as the wound itself. The square on the wound scale is used for 
later digital evaluation (the software recognizes the square and calculates the wound size 
and colour of the wound), hence, the square needs to be clearly visible on a photo and 
remain blank, 
- all photos should be saved with patient’s number and date. Patient’s name or initials 
should NOT be visible anywhere on a photo or used in the file naming. 
5.4.8 Pressure measurement 
Tight Alright system consisting of wearable pressure sensing device and associated software programs 
(mobile app and web app) furnished by FeelTect Limited, will be used to measure and indicate the 

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pressure exerted by compression bandage. For the application technique, please refer to the Instruc-
tion for use.34 
5.4.9 WHAT Tool 
W.H.A.T. (Wound Healing Analysing Tool)45 is a program for assessment of the wound photos, which 
allows objective evaluation and comparison over time. It is designed as a web-based documentation 
platform and needs only several simple and transparent steps (i.e. uploading an image, calibration with 
the calibration square and wound border tracing manually with the mouse) to obtain automatically-
calculated results, such as circumference, area, dimensions, % of granulation or necrosis. 
 
 

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6. Study conduct 
6.1 
Study duration and time plan 
The expected investigation duration is 24 months. Duration of the study active phase (from the first 
ICF till the closure of the last participating site – 18 months). Estimated enrolment period is 12 months. 
The expected participation duration for each patient is maximum 3 weeks (21±2 days). In case a run-
in period is necessary for a patient, maximal participation time will be 28 (±2) days (1 week of a run-in 
period and 3 weeks of the study treatment). 
6.2 
Patient recruitment 
The investigator will inform all potentially eligible patients about the possibility to participate in the 
study. The study will be explained to interested patients in detail by the investigator. The patients will 
get ample time to consider their participation. By signing the informed consent form the patient is 
enrolled in the study.  
6.3 
Randomisation procedure 
A computer-generated random sequence will be used to assign patients in a 1:1 ratio to the treatment 
arm. Randomisation will be stratified by maceration grade at the study entry. Block randomisation with 
randomly varying block sizes (2-6) will be employed to maintain allocation concealment and balance 
the number of patients across groups. 
6.4 
Visit schedule 
During the screening, all patients will be assessed for inclusion and exclusion criteria and wound exu-
dation status. Eligible patients with slight or moderate exudation will be randomly assigned to treat-
ment with either Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB.  
The patients who fulfil all eligibility criteria but have high level of wound exudation will enter a 7-days 
run-in period, during which they will receive superabsorbent dressing (e.g. Vliwazell® Pro, Vliwasorb® 
Pro) and monitored compression therapy with Rosidal® 1C. After this time, these patients should be 
re-assessed and in case they still fulfil all eligibility criteria, and the exudation decreased at least to a 
moderate level, they will be randomised to Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB. In case the 
exudation would not decrease within this period or other eligibility criteria are not met anymore, they 
will be screened out.  
Upon randomisation, all patients will receive the assigned dressing for 21 (±2) days, or till the complete 
epithelialization, if it occurs earlier. There will be a Baseline visit (V1, D0), Interim visit (V2, D10±2) and 
a Final visit (V3, D21±2 or at the moment of the complete healing, if it occurs earlier). In addition, 
dressing changes may be performed in-between the study visits on as needed basis. 
 
 

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Table 3: Schedule of procedures and assessments 
Procedure / Task 
Screening 
Baseline 
Interim 
visit 
Additional visits 
(VA1, VA2, etc.) 
Final Visit / 
Early Termi-
nation Visit* 
Timeline 
(Day – 7) 
Day 0 
Day 10 ± 2 
Each dressing 
change 
Day 21 ± 2 
Inclusion/exclusion criteria 
✓ 
✓ 
 
 
 
Informed consent 
✓ 
 
 
 
 
Assessment of wound exuda-
tion status ** + 
✓ 
✓ 
✓ 
 
✓ 
Measurement of leg circumfer-
ence ** 
✓ 
✓ 
✓ 
✓ 
✓ 
Optional, in case of a high-ex-
uding wound: start of 7 days 
run-in period 
✓ 
 
 
 
 
Pressure data read-out **  
✓ 
✓ 
✓ 
✓ 
✓ 
Demographics 
 
✓ 
 
 
 
Medical history 
 
✓ 
 
 
 
Wound history and previous 
treatment 
 
✓ 
 
 
 
Infection signs assessment (TILI 
and CDC score) **+ 
✓ 
✓ 
✓ 
 
✓ 
Maceration grade assessment 
# 
 
✓ 
✓ 
 
✓ 
Pain assessment (NRS) after 
dressing removal + 
 
✓ 
✓ 
 
✓ 
Wound cleaning / debridement 
**  
✓ 
✓ 
✓ 
✓ 
✓ 
Wound photograph # 
 
✓ 
✓ 
 
✓ 
Wound size and depth # 
 
✓ 
✓ 
 
✓ 
Wound bed status # 
 
✓ 
✓ 
 
✓ 
Surrounding skin assessment # 
 
✓ 
✓ 
 
✓ 
Randomisation 
 
✓ 
 
 
 
Application of assigned study 
dressing 
 
✓ 
✓ 
✓ 
 
Adverse events  
✓ 
✓ 
✓ 
✓ 
✓ 
Concomitant treatment*** 
✓ 
✓ 
✓ 
✓ 
✓ 
Device deficiency 
✓ 
✓ 
✓ 
✓ 
✓ 
Wound Quality of Life ** 
✓ 
✓ 
✓ 
 
✓ 
Complete healing assessment 
 
 
✓ 
 
✓ 
Global assessment investiga-
tor**** 
 
 
 
 
✓ 
Global assessment patient 
 
 
 
 
✓ 
* Some of the activities may be not applicable for patients who have complete epithelialization 
** If screening and baseline visits are performed on the same day, the procedure to be completed only once  
*** Only concomitant medication which is prescribed for the wound treatment or may have effect on the wound treatment 
in general should be recorded (see Annex 1) 
**** By an on-line questionnaire upon completion of the last patient at each site (see Annex 2) 
+ To be assessed just after taking out the wound dressing  
# To be assessed after wound cleaning but before debridement  

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6.4.1 Screening visit (V0, Day -7) 
During the screening visit, inclusion and exclusion criteria and wound exudation status should be as-
sessed. The patients who fulfil all eligibility criteria (inclusion criterion “wound exudation level” may 
be not met at this time) will receive complete information about the investigation and will be provided 
with the informed consent form (ICF) for the familiarization. Patients should give their written in-
formed consent prior to any further study activities. Upon ICF signature the patient is considered in-
cluded into the trial.  
Upon this, for the patients with light or moderate exudation the procedures of Baseline visit (Day 0) 
should be performed (see section 6.4.2).  
The patients with high levels of wound exudation will enter the 7-days run-in period, during which they 
will receive superabsorbent dressing (e.g. Vliwazell® Pro, Vliwasorb® Pro) and monitored compression 
therapy with Rosidal® 1C. During this period, dressing changes and compression adjustment should be 
done by the investigator’s discretion but following the IFU of Rosidal® 1C32 and FeelTect.34 Before ap-
plication of the wound dressing leg circumference should be measured and saved in the application. 
Sub-bandage pressure data should be read-out in supine and standing position and saved in the appli-
cation.  
Registration of (S)AEs/ (S)ADEs/ device deficiencies /incidents for this study starts from the moment 
of the informed consent signature. Since the investigator product or comparator are not used during 
the run-in period, causal relationship to the study product should always be assessed as “unlikely” at 
this timepoint. However, assessment of possible causal relationship with actually used products / pro-
cedures should be provided.  
6.4.2 Baseline visit (V1, Day 0) 
Patients with run-in period after V0: before taking out the compression bandage at baseline visit, sub-
bandage pressure data should be read-out and saved in the application.  
Patients with light or moderate exudation: at the baseline visit wound type*, location and infection 
status will be assessed, and the patients, fulfilling the inclusion criteria without having any of the ex-
clusion criteria will be randomly assigned to treatment with either Suprasorb®X+PHMB Pro or Supra-
sorb®X+PHMB.  
* only venous leg ulcer should be included in the study, i.e. with an ankle brachial pressure index (ABPI) > 0.8 and < 1.2. 
The following procedures will be performed on this day: 
− 
Just after taking out the existing wound dressing should be assessed:  
✓ pain level by NRS;  
✓ signs of infection (TILI and CDC score); 
✓ grade and character of exudation; 
− 
Documentation of patient demographics, medical history, information about intake of rele-
vant concomitant medications.  
− 
Wound cleansing and debridement, according to the local standards. 

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− 
Documentation of wound type, location, history and local status, measurement of leg circum-
ference. In case the patient has several wounds, only one of them should be described within the 
study. The following parameters should be assessed (after wound cleaning but before debridement, 
if necessary): 
✓ size (length, width, depth); 
✓ presence and grade of maceration; 
✓ wound bed status (% of necrotic & fibrinous tissue / granulation); 
✓ surrounding skin status; 
✓ wound photograph (see Section 5.4.7). 
− 
Quality of life assessed by Wound QOL-17. 
− 
Randomisation (including allocation of the study number). 
− 
Application of the assigned study dressing, appropriate secondary dressing and controlled 
compression. Sub-bandage pressure data in supine and standing position should be read-out and 
saved in the application. 
− 
Registration of (S)AEs / (S)ADEs / device deficiencies / incidents, if any should occur.  
6.4.3 Interim visit (V2, D10 ±2) 
During this visit, the dressing change should be performed. Before taking out the compression band-
age, sub-bandage pressure data in supine and standing position should be read-out and saved in the 
application. Just after the removal of the study / comparator product, to be assessed: pain level as-
sessment by NRS, signs of infection (TILI and CDC score) plus grade and character of exudation. Also, 
the main wound parameters should be assessed (after wound cleaning but before debridement, if 
necessary): 
✓ presence of complete healing: in case the complete healing occurred, further data 
should be entered in the Final Visit (V3) form. If the wound is not healed yet: 
✓ size (length, width, depth); 
✓ presence and grade of maceration; 
✓ wound bed status (% of necrotic & fibrinous tissue / granulation); 
✓ surrounding skin status; 
✓ wound photograph (see Section 5.4.7). 
Also, any change in intake of relevant concomitant medications, as well as any (S)AEs / (S)ADEs / device 
deficiencies / incidents should be recorded. Before application of the wound dressing leg circumfer-
ence should be measured and saved in the application. 
The investigator should ensure that the patient receives the same study product as allocated at the 
Baseline visit (i.e. Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB). Appropriate secondary dressing and 
compression should be applied. Sub-bandage pressure data should be read-out in supine and standing 

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position and saved in the application. At the end of the visit, patient should also complete QoL-17 
questionnaire. 
6.4.4 Additional visits (VA1, VA2, etc., at each dressing change) 
In-between the regular study visits, additional visit for dressing change should be performed. The num-
ber and frequency of such visits may vary depending on the wound condition, but it should be taken 
into account that both the study product and the comparator should not stay in a wound for more 
than 7 days. Thus, minimum 2 such visits (between V1 and V2 and V2 and V3) should be performed.  
During these visits, dressing change (including wound cleansing and debridement, if necessary) should 
be performed. Before taking out the compression bandage, sub-bandage pressure data should be 
read-out in supine and standing position and saved in the application. Patient should also be asked 
about occurrence of any (S)AEs, device deficiencies plus any change in intake of relevant concomitant 
medications. Before application of the wound dressing leg circumference should be measured and 
saved in the application. The investigator should ensure that the patient receives the same study prod-
uct as allocated at the Baseline visit (i.e. Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB), appropriate 
secondary dressing and compression. Sub-bandage pressure data should be read-out in supine and 
standing position and saved in the application. 
6.4.5 Final Visit (V3, Day 21±2 or the day the complete healing is achieved or Early Termi-
nation) 
This visit should be conducted after 3 weeks of treatment, or on the day the complete healing is 
achieved, if it occurs earlier.  
During this visit, the following activities should be performed: 
− 
Before taking out the compression bandage, sub-bandage pressure data should be read-out 
in supine and standing position and saved in the application. 
− 
Just after the study dressing / comparator removal to be assessed:  
✓ 
pain level assessment by NRS;  
✓ 
signs of infection (TILI and CDC score); 
✓ 
grade and character of exudation; 
− 
Leg circumference should be measured and saved in the application. 
− 
Documentation of wound status: presence of complete healing should be assessed. 
If the wound is not healed yet: wound cleansing and debridement should be done, if necessary, ac-
cording to the local standards. The following wound parameters should be assessed (after wound 
cleaning but before debridement, if necessary): 
- 
size (length, width, depth); 
- 
presence and grade of maceration; 
- 
wound bed status (% of necrotic & fibrinous tissue / granulation); 
- 
surrounding skin status 

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- 
wound photograph (see Section 5.4.7) should be taken and saved (also in case of com-
plete wound healing). 
− 
Any change in intake of relevant concomitant medications, as well as any (S)AEs / (S)ADEs / 
device deficiencies / incidents should be recorded. 
− 
Also, the patient should complete QoL-17 questionnaire and the questionnaire about the 
product. 
Further therapy, if still necessary, may now be selected by the investigator according to the local stand-
ards of the centre, the type of this therapy should be recorded. 
No further patient data will be collected from this point on, except of the final data regarding SAEs/ 
SADEs which remained unresolved by the time the patient completed participation in the study. Such 
cases should be, whenever possible, followed up upon resolution or till the moment no further follow 
up is possible. 
In case the patient has terminated the study participation earlier by any reason, the parameters listed 
above should be collected, whenever possible. 
Also, the investigator should complete the on-line questionnaire about the study product and the com-
pression bandage after the last patient at the site completed their participation (see Annex 2). 
6.5 
Termination Criteria 
6.5.1 Individual 
Patients may terminate their participation in the study at any time without providing reasons and with-
out any disadvantages for their care. However, it is recommended to collect the reason for voluntary 
discontinuation in case the patient is ready to provide it. 
Patients may be excluded from the study participation if violation of an inclusion or exclusion criteria 
is discovered after the enrolment (will be decided on a case-by-case basis, considering patient’s safety).  
Patients may be excluded from the investigation by the investigator if they violate the clinical investi-
gation plan and if they are not compliant to treatment procedures. 
6.5.2 Centre-specific 
Centres may be excluded from the investigation by the sponsor if repeated major protocol deviations 
(see chapter 11.1) are observed at the site after re-training and reminder to stick to the protocol. 
6.5.3 General 
If unacceptable risks, or incidents leading to an unacceptable benefit-risk assessment are identified 
during the conduct of the PMCF, the study will be terminated immediately by the study sponsor. 

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7. Data Management 
Clinical data will be collected via the certified eCRF System ResearchManager. Patient data will be en-
tered into the electronic case report form (eCRF) directly at the study site. Data will be collected in 
pseudonymized way, patients that are enrolled in the study are assigned to an individual patient ID. 
The sites have to complete a patient identification log to ensure a secure assignment of data. By signing 
the informed consent form, the patient agrees with the collection of specified data during the study 
conduct and transmission of these data to the responsible clinical research organization Axcellant and 
the e-CRF provider ResearchManager.  
7.1 Data Management procedures  
The ResearchManager clinical database is qualified as certified clinical database to record clinical study 
data according to all regulatory requests (ICH E6 Good Clinical Practice (GCP), EU Annex 11, General 
Data Protection Regulation (GDPR), HIPAA (US) , ISO 27001, NEN 7510 and 21 CFR Part 11 compliant). 
ResearchManager allows the direct entry of the patient data at the site via a secure internet connec-
tion (using a registration request document with associate profile). Only authorized users with fixed 
roles have access to the clinical database. The access is controlled and maintained by the Data Man-
agement. Every access is automatically logged and changes of the clinical data are recorded in inde-
pendent audit trails. Any changes of the data entries can be followed by reviewing the audit trails.  
Validation procedures will be established as defined by the Data Validation Plan. Plausibility checks will 
be implemented to avoid or minimize data entry errors. Data cleaning will be performed prior to data 
transfer. 
7.2 
Procedures for data retention 
After the last study activities have been completed the original study documents and their electronic 
copies will be stored in the archive of Lohmann & Rauscher GmbH & Co. KG for a period of 10 years 
(longer archiving periods for patient files as specified by legal regulations have to be observed if appli-
cable). The archive provides storage conditions free from risk of fire, flood, theft and vermin. Access 
to the files is controlled. 

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8. Statistical Considerations 
8.1 
Biometrical aspects of trial design 
This randomised double arm trial is designed to confirm the performance and safety of Supra-
sorb®X+PHMB Pro in comparison to the former product.  
8.2 
Measures against Bias 
To avoid selection bias and to ensure structural comparability of groups the patients will be random-
ised in a 1:1 ratio to each treatment group. Block randomisation with randomly varying block sizes (2-
6) will be employed to maintain allocation concealment and balance the number of patients across 
groups. 
8.3 
Primary Endpoint 
Change in the grade of maceration during 3 weeks of treatment with Suprasorb®X+PHMB (Pro) (by the 
investigators’ assessment as well as by an independent assessment of the wound photos). 
8.4 
Secondary endpoints 
The secondary endpoints are: 
• 
Wound area changes over time (by the investigators’ assessment as well as by an independent 
assessment of the wound photos) 
• 
Change of necrotic & fibrinous / granulation tissue rate in the wound bed (by an independent 
assessment of the wound photos) 
• 
Change of wound infection status during the study (by a TILI and CDC score) 
• 
Product safety (assessed by rate of product-related complications)  
• 
Change of wound exudation and presence of peri-wound oedema (by the investigators’ as-
sessment) 
• 
Change in patients’ pain (measured by NRS scale)  
• 
Product usability (assessed for both Suprasorb®X+PHMB (Pro) and Rosidal 1C by means of user 
and patient questionnaire) 
• 
Change in quality of life (assessed by means of Wound-QoL-17 scale) 
• 
Oedema reduction (by measurement of limb circumference) 
• 
Sub-bandage pressure levels retention (difference of the pressure levels, measured at the time 
of application and before the next dressing change) 
8.5 
Sample size calculation 
Enrolment of 150 patients, under assumption of 5% drop-out rate, will allow to estimate the percent-
age of patients with selected level of maceration at the end of treatment by the study arm with 

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precision equal or greater (i.e. width of 95% confidence interval less than or equal to) 24 percentage 
points for percentage of 50% and increasing (i.e. decreasing width of 95% confidence interval) for per-
centages lower than and higher than 50%. 
8.6 
Analysis population 
Data will be evaluated according to the full analysis set, safety analysis set and per protocol set. 
The full analysis set (FAS) includes all patients randomised independently of the real treatment they 
got – following the intent-to-treat principle.  
The safety analysis set (SAS) includes all patients randomised and treatment started. 
The per protocol set (PPS) includes all patients who were compliant to the procedures as defined by 
the PMCF plan. 
The following patients will be excluded from the per-protocol analysis:  
• 
Patients not meeting the inclusion/ exclusion criteria 
• 
Initiation of study procedure prior to obtaining informed consent 
• 
No available measurements of the primary variable/ endpoint 
• 
Incomplete treatment, i.e. if treatment is discontinued due to complications or an undesirable 
event or for other medical reasons 
• 
Change of assigned treatment to the other group without medical reason 
8.7 
Subgroups 
As a part of exploratory analyses, efficacy analyses will be performed in subgroups by maceration grade 
at the study entry. 
8.8 
Statistical Analysis 
All data available in the CRF and signed by the investigator will be transferred for analysis. Statistical 
analysis will be performed using descriptive and confirmatory statistical methods and no format com-
parisons between study arms will be performed. Statistical analyses will be described in detail in a 
separate document (SAP – Statistical Analysis Plan) once the study plan and the CRF are finalized. 
All efficacy statistical analyses will be conducted for FAS and PP sets separately, and safety analyses 
will be conducted for SAS set. 
The categorical data will be presented as number of non-missing observations, absolute and relative 
frequency, and count of missing observations. All results for continuous variables will be expressed as 
number of non-missing observations, count of missing observations, mean and standard deviation, 
median with range (min./max.).  
Outcome measures will be summarized using descriptive statistics by study arm and by time point of 
assessment. If applicable, changes in relevant parameters (e.g. pain or questionnaires for user satis-
faction) from baseline will be calculated.  

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In assessment of primary endpoint (maceration at end of treatment, measured on 4-point scale) per-
centage of patients with maceration at each of 4 levels of the scale will be reported, by study arm, with 
corresponding two-sided 95% confidence intervals. 
Reported adverse events / incidences and known side effects will be summarized and presented as 
count of events and incidence per event type. 
A level of statistical significance alpha is set at 0.05, what corresponds to the two-sided 95% confidence 
intervals 
The analysis will be performed using the R version 4.1.3 or later (R Core Team (2022). R: A language 
and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. 
URL https://www.R-project.org/.) 
8.9 
Handling of missing data 
Missing data will be listed and documented in the final analysis. 
8.10 
Interim analysis 
An interim analysis is planned upon inclusion of 75 patients (50% of the study population). The exact 
list of the analysed parameters will be described in the Statistical Analysis Plan (SAP). 
8.11 
Final analysis 
The final analysis will be conducted after the end of study, when all observations of all sites were gath-
ered, all data management procedures were completed and widely consistent data without discrep-
ancies are available. The exact details of the final analysis will be described in the Statistical Analysis 
Plan (SAP).  

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9. Safety and Event Handling 
9.1. Definitions 
During the conduct of the PMCF adverse events as defined in ISO 14155:2020 shall be documented by 
the investigators. All adverse events will be evaluated by a medical expert with regard to device rela-
tion. If supplemental information is needed for the evaluation the investigators might be asked to pro-
vide further details. Any adverse event for which relation to the medical device cannot be excluded 
will be included in the safety assessment. 
The following definitions on the basis of ISO 14155:2020 will be used: 
Adverse event (AE) 
Untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including ab-
normal laboratory findings) in subjects, users or other persons, whether or not related to the investi-
gational medical device. 
Note 1 to entry: This definition includes events related to the investigational medical device or the comparator. 
Note 2 to entry: This definition includes events related to the procedures involved. 
Note 3 to entry: For users or other persons, this definition is restricted to events related to the use of investiga-
tional medical devices. 
Adverse device effect (ADE) 
Adverse event related to the use of an investigational medical device. 
Note 1 to entry: This definition includes adverse events resulting from insufficient or inadequate instructions for 
use, deployment, implantation, installation, or operation, or any malfunction of the investigational medical de-
vice. 
Note 2 to entry: This definition includes any event resulting from use error or from intentional misuse of the 
investigational medical device. 
Serious adverse event (SAE) 
adverse event that led to any of the following 
a) death, 
b) serious deterioration in the health of the subject, users or other persons as defined by one or more 
of the following: 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function including chronic diseases, or 
3) in-patient or prolonged hospitalization, or 
4) medical or surgical intervention to prevent life-threatening illness or injury or permanent im-
pairment to a body structure or a body function, 
c) foetal distress, foetal death or a congenital abnormality or birth defect including physical or mental 
impairment 

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Note 1 to entry: Planned hospitalization for a pre-existing condition, or a procedure required by the CIP, without 
serious deterioration in health, is not considered a serious adverse event. 
Serious adverse device effect (SADE) 
Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse 
event. 
Device deficiency 
inadequacy of a medical device with respect to its identity, quality, durability, reliability, usability, 
safety or performance 
Note 1 to entry: Device deficiencies include malfunctions, use errors, and inadequacy in the infor-
mation supplied by the manufacturer including labelling. 
Note 2 to entry: This definition includes device deficiencies related to the investigational medical de-
vice or the comparator. 
Also, the following definitions on the basis of MDR EU Regulation 2017/745 and German MPDG (Mediz-
inprodukte-Durchführungsgesetz), as well as the German MPAMIV (Medizinprodukte-Anwender-
melde- und Informationsverordnung): 
(Serious) Incidents 
− 
‘Incident’ means any malfunction or deterioration in the characteristics or performance of a 
device made available on the market, including use-error due to ergonomic features, as well 
as any inadequacy in the information supplied by the manufacturer and any undesirable side-
effect; 
− 
‘Serious incident’ means any incident that directly or indirectly led, might have led or might 
lead to any of the following: (a) the death of a patient, user or other person, (b) the temporary 
or permanent serious deterioration of a patient's, user's or other person's state of health, (c) 
a serious public health threat 
All SAEs, SADEs, device deficiencies with suspected SADE potential or suspected serious incidents 
according to MDR EU Regulation 2017/745 and national law have to be immediately reported to 
Lohmann & Rauscher GmbH & Co.KG  
• 
by fax at +49 2631 99 1566 or  
• 
by e-mail at Vigilance.int@de.LRMed.com, Martin.Abel@de.LRmed.com (Vigilance Officer 
L&R) and Daria.Trofimenko@de.LRMed.com (L&R Project Manager for the study) 
9.2. Documentation of AEs/SAEs, device deficiencies and (serious) incidents 
All AEs will be documented in the CRF including all information listed below. Exempted are the follow-
ing conditions, which will be documented in other CRF sections: 
• 
Occurrence or increase of infection signs  
• 
Wound size increase  
• 
Signs of maceration  

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• 
Injury to the wound ground during dressing change  
• 
Increase of pain or exudation. 
Also, pre-existing diseases and conditions (already present before the first application of the medical 
device) are not documented as adverse events but as concomitant diseases.  
The AEs should be documented in the CRF including the following information: 
• 
Date and time of onset and resolution 
• 
Severity 
• 
Causal relationship with a medical device / procedure 
• 
Seriousness 
• 
Measures taken in respect to AE, including interruption or withdrawal of investigation treat-
ment  
• 
AE status at the end of study 
The investigator will classify the severity of AEs as follows: 
• 
Mild: clinical symptoms or signs that are well tolerated and do not interfere with everyday 
activities 
• 
Moderate: clinical symptoms or signs that are enough to impair everyday activities 
• 
Severe: clinical symptoms or signs that markedly impair the trial subject and result in an ina-
bility to work or go about everyday activities 
The investigator will assess for every AE whether a causal relationship with the medical device / study 
procedure can be assumed or not. The assessment includes consideration of the nature and type of 
reaction, the temporal relationship with the medical device, the clinical status of the trial subject, con-
comitant medication and other relevant clinical factors. If the event is considered to appear due to lack 
of efficacy or as a symptom or sign of the underlying disorder, no causal relationship should be as-
sumed. 
The following definitions are used to assess the causal relationship between all AEs and the medical 
device: 
• 
Certain: clinical event, including laboratory test abnormality, occurring in a plausible time re-
lationship to medical advice application or procedure, and which cannot be explained by con-
current disease or other measurements/ procedures. If the event disappears after interruption 
of treatment with the study product (or comparator) and reappears after its re-application 
(satisfactory rechallenge procedure), this event is to be regarded as certainly related to the 
product.  
• 
Probable/likely: clinical event, including laboratory test abnormality, with a reasonable time 
sequence to medical advice application or procedure, unlikely to be attributed to concurrent 
disease or other measurements/procedures, and which follows a clinically reasonable re-
sponse on withdrawal (rechallenge). Rechallenge information is not required to fulfil this def-
inition. 

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• 
Possible: clinical event, including laboratory test abnormality, with a reasonable time se-
quence to medical advice application or procedure, but which could also be explained by con-
current disease or other measurements/procedures. Information on withdrawal of the study 
product (or comparator) may be lacking or unclear. 
• 
Unlikely: clinical event, including laboratory test abnormality, with a temporal relationship to 
medical device application or procedure which makes a causal relationship improbable, and 
for which other drugs, measurements/procedures or underlying disease provide plausible ex-
planations. 
• 
Conditional/unclassified: clinical event, including laboratory test abnormality, reported as an 
adverse reaction, for which more data is essential for a proper assessment or the additional 
data are under examination. 
• 
Unassessable/unclassifiable: report suggesting an adverse reaction which cannot be judged 
because information is insufficient or contradictory, and which cannot be supplemented or 
verified. 
Regardless of the assumed causal relationship, every SAE that occurs during the investigation (from 
the moment of ICF signature by the patient) must be documented in the appropriate part of the AE-
CRF and sent to the sponsor within 24 hours. Non-serious AEs will be processed after the AE-CRF is 
collected and forwarded to the sponsor. 
Regardless of whether a causal relationship between a SAE and the medical device is suspected, trial 
subjects who develop serious adverse events must be monitored until all symptoms have been sub-
sided, pathological laboratory values have returned to pre-event levels, a plausible explanation is 
found for the SAE, the trial subject has died, or the investigation has been terminated for the trial 
subject concerned.  
All device deficiencies and (suspected serious or serious) incidents, revealed during the study, should 
be directly reported to the sponsor’s vigilance team. Prior to the reporting, the investigator should 
preliminary assess the event for the presence of seriousness criteria, according to MDR EU Regulation 
2017/745 and the German and Polish law. In case the deficiency / incident met one of such criteria, 
expedited reporting (within 24 hours) is required. Also, in case the event is related to the study patient, 
corresponding SAE form should be completed and sent within 24 hours. Assessment and processing of 
the adverse events, device deficiencies and (suspected serious or serious) incidents will be performed 
by the sponsor. 

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10. 
Monitoring 
During the conduct of the PMCF monitoring will be performed. A monitor will have regular contacts 
with the investigation sites.  
A risk-based monitoring approach will be utilized for the study data.  
It has to be verified that the study is conducted according to the study plan, subsequent amendments, 
and the applicable legal requirements. 
The following visits will be performed during the study: 
- Site qualification / selection visit; 
- Initiation visit; 
- Routine monitoring visits for data review and ongoing sites’ assistance; 
- Close out visit after the end of the documentation. 
Detailed information about the amount and the scope of the monitoring will be presented in the mon-
itoring plan.  

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11. 
 Deviations from the study investigation plan  
Protocol deviation is any noncompliance with the study protocol or requirements laid down in the EN 
ISO 14155:2020 (Clinical investigation of medical devices for human subjects — Good clinical practice). 
The noncompliance may be either on the part of the study patient, or the investigator / study site staff. 
As a result of deviations, corrective actions are to be developed by the site and implemented promptly. 
It is the responsibility of the investigator to identify and report deviations within 5 working days of the 
identification. All deviations must be addressed in study source documents and reported to the re-
sponsible LEC(s), if required by their policies. The site investigator is responsible for knowing and ad-
hering to the reviewing LEC requirements.  
11.1 
Major deviations 
The following deviations will be considered major deviations and will lead to the exclusion of the pa-
tients from the PP population: 
• 
No informed consent form available for a patient or informed consent form was not signed by 
a patient themselves; 
• 
Initiation of any study procedure prior to obtaining informed consent; 
• 
Inclusion of non-eligible patient (deviation of the inclusion / exclusion criteria); 
• 
Change of the initially assigned study product during the course of treatment. 
Further major protocol deviations may be defined during the conduct of the trial, if deemed relevant. 
The list of major protocol deviations will have to be finalized and documented (for example, in the data 
review minutes) prior to the database lock. 
In case of repeated major protocol deviations at the site, study sponsor may make a decision of its 
closure.  

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12. 
 Regulatory and Ethical Considerations 
To fulfil requirements on medical device manufacturers, Lohmann & Rauscher GmbH & Co. KG con-
ducts this multicentre, randomised in parallel groups, controlled study within the framework of Post-
Market Clinical Follow-up (PMCF) in accordance with MEDDEV 2.12/2 rev. 2 and MDR EU Regulation 
2017/745. Compliance with the applicable Polish legislation (Medical Devices Act of 7 April 2022 ) and 
MEDDEV 2.12-1 will be ensured. 
The post-CE-mark randomised controlled study allows a continuous assessment of the benefit-risk pro-
file for the given intended use with selection of patients according to the provided indications. Since 
additional examinations, which may be burdensome to the patients, are planned (continuous pressure 
measurement with a wireless pressure sensor; photographic wound documentation; completion of 
paper scales / wound questionnaires), the study will require notification to  the Polish competent au-
thority: The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products . 
Sponsor of the study will take over the insurance in accordance with the Polish Law. 
The PMCF study will be conducted in accordance with the World Medical Association Declaration of 
Helsinki (Fortaleza, Brazil, October 2013), and as far as applicable with ISO 14155:2020 Clinical Inves-
tigation of Medical Devices for human subjects - Good Clinical Practice.   
According to their professional regulations, consultation of the competent ethics committees is re-
quired by the participating physicians.   

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13. 
Study Report and Publication Policy 
The data resulting from this study will be collected on behalf of L&R and will be analysed after all 
patients have completed the study, and all data validation checks have been performed. The results 
will be provided in a study report, which will be submitted to the involved ethics committee(s). 
It is planned to publish the trial results in a scientific journal and to present them at German and / or 
international congresses. The order of authorship will be determined by the sponsor and will be based 
in part on the number of qualified and completing patients at each site.  
Publication will be compliant with the document titled “Guidance on the publication of the clinical 
investigation reports and their summaries in the absence of EUDAMED”- MDCG 2024-15 dated No-
vember 2024. 
Sponsor of the study will also fulfil Article 77 of Regulation (EU) 2017/745 titled “Information from the 
sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination”. 
Any published data will observe data protection legislation covering the study patients and investiga-
tors. Success rates or individual findings at individual trial sites will be known to the sponsor only. By 
signing the contract to participate in this trial, the investigator declares agreement to submission of 
the results of this trial to national and international authorities for approval and surveillance purposes, 
and to the Federal Physicians Association, the Association of Statutory Health Fund Physicians and to 
statutory health fund organizations, if required. At the same time, the investigator agrees that their 
name, address, qualifications, and details of their involvement in the clinical trial may be made known 
to these bodies. 
The publication or presentation of the results of a single study centre requires prior notice and prior 
review and approval from the sponsor. 
The support by L&R is to be mentioned in any publication. L&R staff will be included as co-authors as 
applicable. A copy of all publications should be sent to L&R. 
 
 

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14. 
Contact Information 
Sponsor 
Lohmann & Rauscher GmbH & Co. KG 
Irlicher Straße 55 
56567 Neuwied, Germany 
 
Project Manager 
Dr Daria Trofimenko 
Senior Manager Clinical Regulatory Affairs 
Lohmann & Rauscher GmbH & Co. KG 
Phone:  0049 2631 99 6385 
Fax: 
0049 2631 99 1385 
Email: daria.trofimenko@de.lrmed.com 
 
Vigilance Officer 
Dr Martin Abel 
Head of Clinical Regulatory Affairs and Vigilance Officer 
Lohmann & Rauscher GmbH & Co. KG 
Phone:  0049 2631 99 6566 
Fax: 
0049 2631 99 1566 
Email: martin.abel@de.lrmed.com 
 
CRO 
Patrycja Buczak-Kula 
Project Director  
AXCELLANT 
Phone:  0048 608577557 
Email: pkula@axcellant.com 
 
 
 

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15. 
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28. de Moraes Silva, M. A., Nelson, E. A., Bell-Syer, S. E., Jesus-Silva, S. G., & Miranda, F. Jr. (2024). 
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