Prospective Randomized Evaluation of the Effect of Avance® Solo Negative Pressure Wound Therapy System or Optifoam® Gentle Post-Op Dressing on "High Risk" Closed Surgical Incisions; Freedom From Wound Complication Study
Phase: NA
Conditions: Diabetes, Morbid Obesity, Lymphedema, Orthopedic Disorder
Sponsor: Icahn School of Medicine at Mount Sinai

Prospective Randomized Evaluation of the Effect of Avance® Solo Negative Pressure 
Wound Therapy System or Optifoam® Gentle Post-Op Dressing on "High Risk" Closed 
Surgical Incisions; Freedom From Wound Complication Study
PI: John Lantis, MD
NCT05427916
Document Date: 05/10/2022

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CLINICAL IN MARKET 
EVALUATION PROTOCOL 
EVALUATION NUMBER: 
CINPWT 
EVALUATION TITLE: 
Prospective randomized evaluation of the effect of  
Avance® Solo Negative Pressure Wound Therapy System 
or Optifoam® Gentle Post-Op Dressing on “high risk” closed 
surgical incisions; freedom from wound complication study 
PRODUCT: 
Avance® Solo Negative Pressure Wound Therapy System 
(Best Practices – Optifoam® Gentle Post-Op) 
SPONSOR: 
Investigator Initiated 
Postal address: 
Mount Sinai West 
 
 
 
New York, NY 10019 
Telephone: 212-523-4797 
AUTHOR: 
John C Lantis II, MD 
CENTER SPECIFIC DETAILS 
EVALUATION CLINICIAN NAME:     
John C Lantis II 
CENTRE NAME: 
Mount Sinai Department of Surgery 
CENTRE ADDRESS: 
 
 New York, NY 10019 
CO-ORDINATOR NAME: 
Denise Alabi 
TELEPHONE NUMBER: 
212 523 5915 
FAX NUMBER: 
212 523 1645 
E-MAIL:
Denise.Alabi@mountsinai.org 
DOCUMENT CONTROL 
THIS ISSUE: 
Draft 5 
05/10/2022 
PREVIOUS ISSUES: 
Draft 4 
Draft 3 
Draft 2 
Draft 1 
04/05/2022 
03/21/2022 
03/14/2022 
02/01/2022 
DOCUMENT CIRCULATION 

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THIS IS THE PROPERTY OF THE INVESTIGATOR  AND SHOULD NOT BE REPRODUCED 
IN WHOLE OR IN PART OR CIRCULATED WITHOUT PRIOR AUTHORISATION FROM THE 
INVESTIGATOR . 

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APPROVAL AND AGREEMENT 
I confirm that the evaluation product will be used in accordance with its licensed 
instructions for use 
.................. 
 ........................................................ 
 ........................................................ 
Date 
Evaluation Clinician Signature 
Name (Printed) 
The evaluation Clinician confirms that IRB opinion has been sought and approval is: 
•
Full approval has been obtained
r 
…………… 
 ……………………………………. 
 ……………………………  
Date 
 Evaluation Clinician Signature 
 Name (Printed) 
If IRB approval is required, the evaluation clinician must submit the evaluation 
protocol to the IRB. If approval is required, the first patient will not be enrolled into the 
Clinical In-Market Evaluation until the local Molnlycke evaluation coordinator has 
been sent a copy of the approval letter in which the protocol are mentioned by name 
and number. 

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1 
INTRODUCTION 
1.1 
RATIONALE 
To determine if “high risk” surgical incisions develop healing complications 
within 21 days of surgery.  High risk is defined as a standard incision in the “ high risk 
patient” (diabetes, obesity, poor anatomy, malnutrition).  Or a “high risk incision” such 
as a foot and ankle incision, flap incision or major soft tissue resection with a large 
amount of dead space.  
A healing complication is defined as the presence of at least one of these 
clinical scenarios: infection (superficial or deep), (evidenced by the prescription of 
oral antibiotics,(partial, superficial, or deep), or delayed healing (incision not 100% 
closed within 7 days of the first surgical procedure). Ongoing wound drainage from 
the incision after 96 hours, periwound erythema, minor dehiscence or major 
dehiscence. 
The purpose of this study is to assess the efficacy of the FDA cleared device, 
Avance® Solo, an device that delivers negative pressure wound therapy to closed 
incisions  (NPWTi), and to assess the number of healing complications that result 
from its use1, 2, compared to the current hospital standard Optifoam® Gentle Post op 
Dressing (a silicone backed foam that is conformable, with a border that is 
waterproof, flexible and breathable for increased comfort, with a wear time of up to 
seven days).  This foam is currently stocked by the operating rooms at Mount Sinai 
hospital and indicated for use in high risk wounds (although there is no data to 
support its usage). 
Historically, the use of negative pressure wound therapy for surgical incisions 
can assist in the management of surgical incisions.  There are thought to be at least 
6 positive mechanisms of action; protects the incision from the external environment, 
removes surface drainage and lymphatic drainage, resists gaping through application 
of lateral tension, increase breaking strength of healed incisions, reduces seroma 
and haematoma fluid collections, reduces edema, improves perfusion compared to 
area not treated with NPWT. 
Many papers (primarily single center, single arm and or underpowered 
studies have supported the use of closed incisional NPWT. Previous basic science 
research has shown that NPWTi has a significant impact on improved incisional 
outcomes. Some have been small studies such as Pachowsky et al (2011) 
Nuremberg, Germany, who ultrasounded total hip arthroplasty: 9 patients with 
iNPWT in place for 5 days vs. 10 patients with standard dressings. He showed a 
reduction in volume of periwound seromas.3 
The largest study to date randomized the effect of NPWTi in 249 patient with 
263 fractures. Groups were matched for different types of fracture. The average use 
of NPWT was for just 2.5 days and a statistically significant reduction in deep 
infection: 19.0 v 10.0% P = 0.049; and dehiscence  was observed 16.5 v 8.6% 
P=0.044.4  
Please note for greater than 15 years there has been wide usage of the 
NPWTi by the investigator.  The evidence supporting the theoretical use of this 
device is beyond the scope of this protocol. 

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1.2 
OBJECTIVE(S) 
The primary objective is to assess the frequency of a wound healing complication, in 
a closed incisional wound in a “high risk”  surgical incision when treated with NPWTi 
versus a highly absorbent antimicrobial post – operative absorbent dressing. 
(HAAMPOD). 
A healing complication is defined as presence of at least one of the following 
conditions: infection (superficial or deep), dehiscence (partial, superficial, or 
deep), or delayed healing (incision not 100% closed within 7 days of the first 
surgical procedure), drainage form the wound after 96 hours post operatively. 
The secondary objectives are to assess any changes in the following assessments of 
the surgical incision weekly over the treatment period:  
•
Surrounding skin condition
•
Incision complications, infection or clinical signs of infection
▪
to assess the number and type of these complications individually
including other postsurgical complications: skin necrosis, cellulitis,
abscess, suture abscess, seroma, periwound edema or hematoma
occurring within 21, 42, and 90 days postoperatively
•
Pain during dressing changes
Assessment of the following at dressing changes: 
•
Duration/wear time
•
Ease of use; difficulty with sleep
•
Damage to surrounding skin on removal
•
Assessment of re-epithelialization/closure
•
Patient comfort during wear; ease of ambulation
•
Conformability of dressing
•
Exudate management
•
Reasons for removal
To assess the overall comparison of Avance® Solo to the HAMMPOD. 
2 
EVALUATION DESIGN 
2.1 
EVALUATION DESIGN 
Open label, two armed, prospective, single center, quality equivalency assessment. 
Immediate post operative application of Avance® Solo Negative pressure wound 
therapy on “high risk” closed surgical incisions.  Versus the hospital best clinical 
practice dressing HAAMPOD. (Please note there is no prospective clinical data 
driven data, the hospital purchasing department develops and indicates the brand 
based upon cost). 
The patient will be undergoing: 

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•
Foot and ankle surgery
•
Vascular groin incision, vascular axillary incisions
•
Long leg vein harvest incision
•
Closed forefoot and major amputation surgery
•
Possibly: breast augmentation and reduction surgery
*Note: The surgical indication is chosen based upon previously published data of
high risk incisions. (It is beyond the scope of a protocol to educate the IRB in regards
to the full definitions of high risk surgical inicisions)
Patients will participate in the study for 4 applications or up to 2 weeks 
treatment, whichever comes first. During this time clinicians will be asked to complete 
questions pertaining to the incision and to the performance and overall acceptability 
of Avance®Solo or the HAAMPOD. 
Throughout the evaluation patients will be treated according to the product 
instructions for use for either product.  
3 
EVALUATION PRODUCT(S) 
3.1 
DESCRIPTION OF EVALUATION PRODUCT(S) 
Avance® Solo will include the collective description for a complete device capable of 
delivering negative pressure to the incision site and managing exudate generated by 
the incision. It comprises: 
“This investigation pertains to Avance®Solo, a single use battery powered negative 
pressure system, with Mölnlycke as the legal manufacturer with its headquarter 
located in Gothenburg, Sweden. Avance®Solo consists of different products that are 
FDA compliant, which together form a system for wound management via the 
application of negative pressure (Figure 2). Avance®Solo maintains negative 
pressure nominally at -125 mmHg on low and moderately exuding wounds. The 
pump is pocket sized and can be carried in a pocket or attached to a belt with a belt 
clip that is assembled with the pump. To maintain the pressure, there is a recycling 
sound. To reduce the sound of cycling, a night case can be used to facilitate comfort 
during sleep.” 
A proprietary Controlled Fluid Management (CFM) technology, the Avance® Solo 
single use negative pressure system shares fluid management between an 
absorptive multi-layered dressing and a 50ml canister, reducing the potential for 
dressing saturation.  This technology is theoretically designed to reduce the potential 
loss of therapy arising from dressing saturation. 
•
The addition of a canister to the absorptive dressing ensure the dressing does
not become overwhelmed with draining and therapy will continue to be
delivered regardless of dressing saturation

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•
Sharing fluid management between an absorptive dressing and canister can
reduce the frequency of dressing changes
•
Avance® Solo NPWT system continues to deliver negative pressure to the
wound site, even with low to moderate amounts of fluid saturation in the
dressing
•
Avance® Solo features both audible and visual alarms so therapy can be
restored in an efficient timely manner
•
Avance Solo Border dressings Safetac® adhesive has been proven to
minimise trauma to wound site and surrounding skin upon dressing removal
•
-125mmHg continuous negative pressure
The pump is a controllable vacuum pump apparatus, which can be left to operate 
automatically, delivering continuous negative pressure (nominally -125mmHg) to the 
incision site.  The pump’s lifetime is 14 days and is powered with 2 lithium batteries 
specific to the pump. Batteries shall be replaced once pump alarms for Low battery 
or after 7 days. 
The control product (HAAMPOD) has not undergone any prospective randomized 
controlled trial. (Optifoam® Gentle Post-Op).  It has been deemed equivalent and 
acceptable therapy for the Mount Sinai West Operating room, by equivalency data by 
the Mount Sinai purchasing group.  
Precautions: 
The use of anticoagulants does not deem a patient inappropriate for treatment with 
the Avance® Solo, however, haemostasis must be achieved before applying the 
dressing and continued frequent assessment must be maintained and considered 
throughout the therapy.  
Avance® Solo must not be placed over exposed arteries, veins or organs. Greater 
care should be taken with respect to weakened, irradiated or sutured blood vessels 
or organs.  
Avance® Solo is contraindicated for patients with malignancy in the incision site or 
margins of the incision (except in palliative care to enhance quality of life), previously 
confirmed and untreated osteomyelitis, non-enteric and unexplored fistulaes, sinus 
tracts and areas of tunnelling or necrotic tissue with eschar or exposed anastomotic 
sites, use over exposed blood vessels, nerves or organs or use on exposed bone or 
tendon unless a non-adherent dressing is used to protect the exposed areas. 
Avance® Solo is registered in the country of use (CE marked for Europe and 510k 
approved for the US). 
A number of different dressing sizes are produced by the sponsor, Molnlycke (shown 
in Table 1).   
Table 1: Molnlycke dressing sizes 
Dressing size 
Effective pad size 
Pad Area (cm2) 

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10cm x 20cm 
5cm x 15cm 
75 
10cm x 30cm 
5cm x 25cm 
125 
10cm x 35cm 
5cm x 30cm 
150 
15cm x 15cm 
10cm x 10cm 
100 
15cm x 20cm 
10cm x 15cm 
150 
15cm x 30cm 
10cm x 25cm 
250 
20cm x 20cm 
15cm x 15cm 
225 
25cm x 25cm 
20cm x 20cm 
400 
The dressing and pad sizes that will be used for the closed incision wounds in this 
study are listed below (shown in Table 2).  
Table 2: Dressing sizes to be used in the study 
Dressing size 
Effective pad size 
Pad Area (cm2) 
10cm x 20cm 
5cm x 15cm 
75 
10cm x 30cm 
5cm x 25cm 
125 
10cm x 35cm 
5cm x 30cm 
150 
15cm x 20 cm 
10cm x 15cm 
150 
15cm x 30cm 
10cm x 25cm 
250 
3.2 
OPTIFOAM® GENTLE POST-OP – (MEDLINE IN, NORTHFIELD IL) – IS  A 
“SILICONE FACED AND BORDERED POST OPERATIVE FOAM AND 
SUPERABSORBENT CORE AND FLEXIBLE DESIGN.” (PER PACKAGE 
INSERT) THIS PRODUCT IS DEEMED ADEQUATE FOR HIGH RISK 
SURGICAL INCISIONS PER MOUNT SINAI VALUE ANALYSIS/ (NOT 
SUBJECT TO IRB APPROVAL NOR REVIEW)/PURCHASING. WHICH WILL 
BE KEPT IN PLACE FOR UP TO 7 DAYS  (PER PACKAGE INSERT), 
ALTHOUGH DRESSING CHANGES UP TO 4 PER 14 DAYS WILL BE 
ALLOWED. *NOTE THIS PRODUCT IS SUBJECT TO CHANGE BASED UPON 
MOUNT SINAI PURCHASING CONTRACTS. 
Dressing size 
Effective pad size 
Pad Area (cm2) 
10.2 x 20.3 cm 
5.1 cm x 15.2 cm 
77.5 
10.2 x 25.4 cm 
5.1 cm x 20.3 cm 
103.5 
10.2 x 30.5 cm 
5.1 cm x 25.4 cm 
129.5 
a. PACKAGING AND LABELLING
2. All evaluation products will be supplied in standard packaging.  No additional
labelling will be appended to the evaluation products.
 

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a. METHOD OF DISTRIBUTION
3. Delivery of product and will be arranged and agreement between Molnlycke
and the center.
3.3 
RECONCILIATION 
All evaluation products, which have not been used by the end of the evaluation, must 
be returned to Molnlycke. The clinician will maintain an inventory, which will include 
details of receipt, use and return of all evaluation products (Appendix 1). The control 
product will be managed by the Mount Sinai West operating room product acquisition 
supply system.  
4 
EVALUATION PATIENT POPULATION 
4.1 
NUMBER OF PATIENTS 
30 patients in each arm meeting the inclusion criteria 
4.2 
PATIENT SOURCES 
Patients will be recruited from the Mount Sinai West Hospital general (includes 
Plastic surgery as a Division of Plastic Surgery) and orthopedic surgery practices of 
foot and ankle surgery, vascular surgery, general surgery, and Plastic surgery.  
These practices have a similar location for outpatient follow-up of 
 
 New York New York, 10019. USA. 
4.3 
SELECTION CRITERIA 
Patients with an incision deemed suitable for treatment with Avance® Solo or 
HAAMPOD will be screened against the inclusion and exclusion criteria. Only 
patients who meet the eligibility criteria will be included in the evaluation. For patients 
with more than one incision, only the largest or most suitable of their incisions will be 
included in the evaluation and will need to be in line with the instructions for use and 
contraindication instructions and will be an incision which fits the dressing sizes 
included. 
Only 1 dressing per incision must be used on an incision and this incision will 
be referred to as the reference incision. Any other incisions the patient may have will 
be treated in accordance with standard local procedures.  The 1st dressing will be 
placed immediately upon completion of the operation 

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4.3.1 
Inclusion Criteria 
The following criteria must be met before a patient is recruited to the evaluation: 
•
The patient must be at least 18 years of age
•
Males and females - provided they are not pregnant and if of reproductive age
are using contraception.
•
Have a closed surgical incision post-surgery/closure (<24 hours after).
•
The patient is able to understand the evaluation and is willing to consent to
the evaluation.
•
Undergoing appropriate: wound “high risk” surgery
•
Foot and ankle surgery
•
Vascular groin incision
•
Long leg vein harvest incision
•
Closed forefoot and major amputation surgery
•
Breast augmentation and reduction surgery
•
Patient on metabolic agent, immunosuppressants, or steroid therapy will
not be excluded from this study
• 
4.3.2 
Exclusion Criteria 
•
Incisions in excess of effective dressing pad size provided.
•
Patients with a known history of poor compliance with medical treatment.
•
Patients who have participated in this trial previously and who were
withdrawn.
•
Patients with known allergies to product components (silicone adhesives and
polyurethane films (direct contact with incision), acrylic adhesives (direct
contact with skin), polyethylene fabrics and super-absorbent powders
(polyacrylates) (within the dressing).
•
Incisions where daily inspection is required underneath the dressing.
•
Incisions which have an infection which is not being treated with systemic
antibiotics.
•
Incisions which are actively bleeding.
•
Exposure of blood vessels, organs, bone or tendon at the base of the
reference incision.
4.3.3 
Manufacturers recommended use will be adhered to: 
•
Before starting therapy, evaluate the patient’s nutritional status and address
severe malnutrition.
•
Signs of possible infection or complications must be addressed immediately.
Monitor the device, wound, surrounding skin, and patient status accordingly to
ensure effective and safe treatment and patient comfort.
•
For patients with ischemic condition or at application of a circumferential
dressing, extra monitoring of wound status is required to avoid risk of
compromised circulation.

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•
Avance Solo Pump is equipped with visual and audible notifications and
alarms. Ensure that carrying or placement of the pump allows the user to
detect audible and visual notifications and alarms.
•
When Avance Solo Pump battery low alarm is triggered, replace the batteries
in the pump. Only use the type and model of lithium batteries specified for this
product by Mölnlycke Health Care, see section 8.
•
Fixation strips provided with the dressing shall only be applied on dressing
borders. Do not apply fixation strips, or other occlusive dressings, across the
dressing wound pad due to the risk of low breathability leading to maceration.
•
Application of certain skin protection products or using cleansing products
prior to the application of the dressing, can affect the ability of the dressing
and fixation strips to adhere securely and create sufficient sealing.
•
Do not use the products on patient and/or user with known hypersensitivity to
the ingoing materials/components of the products.
•
Ingrowth of tissue may occur if the dressing or wound filler is not changed in
accordance with recommendations or as appropriate for the wound condition
of the individual patient (See Section 6.6).
•
Consider use of non-adherent wound contact layer (Mepitel) to protect fragile
tissue.
•
Do not place the pump with canister in water or other liquids. Disconnect the
pump and canister if the ingress of water is observed.
•
For daily hygiene routines do not expose the pump with canister or dressing
to extensive contact with water.
•
Avance Solo Border Dressing should only be applied and changed by
healthcare professional.
•
No modification of this device (pump, canister, tubing, dressing, foam) is
allowed as modifications may significantly compromise the ability of the
system to deliver therapy.
•
Do not disassemble the pump.
•
Products in Avance Solo NPWT System should not be used with products
from other NPWT systems.
•
Do not cut the tubing or detach tubing from the canister.
•
Do not cut the dressing.
•
For CT scans and X-ray investigations, keep the pump out of the X-ray or
scanner range. In the event that the pump is within a CT-scan or X-ray range,
ensure to check that the pump functions correctly after the procedure.
•
Avance Solo Pump is not intended for use aboard aircraft. Remove batteries
during air travel.
•
Avance Solo NPWT System products are provided sterile. Do not use if the
sterile barrier is damaged or has been opened prior to use. Do not re-sterilize.
•
Avance Solo Pump is for single patient use.
•
Avance Solo Border Dressing, Avance Solo Foam and Avance Solo Canister
50 ml are single use.
•
Do not reuse Avance Solo NPWT System products. If reused, performance of
the product may deteriorate, cross contamination may occur.
•
HAAMPOD will be placed via commercially available dressing instructions.
Ensure that the battery lid on the Avance Solo Pump is closed during therapy. 

 
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4.4 
WITHDRAWAL 
Any patient who interrupts the evaluation treatment for longer than 3 days will be 
withdrawn from the evaluation. 
Patients who do not respond to therapy should be withdrawn from the evaluation only 
at the point where it becomes necessary to change the treatment on clinical grounds. 
Patients may drop out or be withdrawn for the following reasons:- 
• 
at their own request* 
• 
at the discretion of the clinician (because of lack of response, an adverse 
incident, poor compliance etc.). 
• 
as their incision is no longer suitable for treatment with Avance® Solo  
* Although patients need not give a reason for requesting withdrawal from the 
evaluation, the Clinician should make a reasonable effort to ascertain the reason(s), 
while fully respecting the patient's rights. 
Patients who drop out or who are withdrawn from the evaluation will not be replaced 
if they have been entered onto the study and have received evaluation treatments. 
Patients who drop out or who are withdrawn or whose wound heals will not be re-
entered into the evaluation at a later date. 
 
5 
TREATMENT PLAN 
5.1 
TREATMENT REGIME 
Patients will be informed of the evaluation requirements and asked to give informed 
consent prior to any evaluation activities taking place.  
Patients meeting the eligibility criteria and agreeing to consent to their participation in 
this evaluation will receive treatment with Avance® Solo for a maximum of 2 kits or up 
to a maximum of 2 weeks treatment, whichever comes first. If randomized to 
HAAMPOD the patient will have a dressing applied per manufacturers guidelines. Up 
to 4 dressings will be applied over 14 days. Treatment will commence on Day 0 and 
dressing changes will take place as deemed necessary by the evaluation Clinician.  
Avance® Solo should be applied in accordance with standard protocols and the 
product instructions for use. 
The following table details the treatment regime for participation patients in the study. 
 
Pre-Trial 
Investigator discusses evaluation with the patient 
and provides the patient with a centre consent form 

 
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for use of their data and photographs.  
Patient provides informed consent                
Complete eligibility checklist and medical history     
Maximum of 2  weeks Treatment 
First Dressing 
Application (Day 0) 
 
Incision assessment                                          
Incision photograph                                               
First dressing application                                    
Video recording may be carried out 
Second Dressing 
Application 
First dressing removal                                      
Incision assessment                                         
Incision photograph                                           
Second dressing application                               
Video recording may be carried out 
Third Dressing 
Application 
Second dressing removal                                 
Incision assessment                                         
Incision photograph                                              
Third dressing application                                   
Video recording may be carried out                              
Fourth Dressing 
Application 
Third dressing removal                                     
Incision assessment                                         
Incision photograph                                             
Fourth dressing application                                
Video recording may be carried out                              
 
Post Study 
A patient interview may be carried out  
 
 
 
At each dressing change the following will be assessed: 
 
• 
Duration/wear time 
• 
Ease of use; 
• 
Difficulty with sleep  
• 
Damage to surrounding skin on removal 
• 
Assessment of re-epithelialization/closure 
• 
Patient comfort during wear 
• 
Ease of ambulation  
• 
Conformability of dressing 
• 
Exudate management  
• 
Reasons for removal 
 
5.2 
FURTHER POST OPERATIVE EVALUATION  
The patient will be seen on day 21 (±3), 42 (± 5) and 90 (± 7) at all time points the 
wounds will be assessed for:  

 
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Healing complications,  defined as presence of at least one of the following: 
• 
infection (superficial or deep) 
• 
dehiscence (partial, superficial, or deep) 
• 
delayed healing (incision not 100% closed within 7 days of the first surgical 
procedure).  
• 
Ongoing wound drainage > 7 days post operatively 
Secondary objectives are to assess the number and type of these complications 
individually including:  
• 
wound drainage, type and amount;  
• 
wound margin and periwound areas;  
• 
and other aspects including but not limited to odor, pain, and need for 
debridement.   
• 
skin necrosis, incisional pain, cellulitis, abscess, suture abscess, or 
hematoma occurring within 21, 42, and 90 days postoperatively. 
5.3 
RESTRICTIONS 
In the event that defibrillation is required, disconnect the pump from the dressing 
prior to defibrillation.  Remove the dressing if it is positioned in a location that will 
interfere with defibrillation.     
Avance® Solo is not MRI compatible.  Do not take Avance Solo into the MRI suite. 
Avance® Solo has not been studied on paediatric patients.  Patient size and weight 
should be considered when prescribing this therapy. 
Avance® Solo is unsuitable for use in areas where there is a danger of explosion 
(e.g. hyperbaric oxygen unit). 
Avance® Solo is not suitable for use in the presence of a flammable anaesthetic 
mixture or with oxygen or nitrous oxide. 
The use of anticoagulants does not deem a patient inappropriate for treatment with 
Avance® Solo , however haemostasis must be achieved before applying the 
dressing and continued frequent assessment must be maintained and considered 
throughout the therapy. 
At all times care should be taken to ensure that the pump and tubing does not: 
• 
Lie in a position where it could cause pressure damage to the patient. 
• 
Trail across the floor where it could present a trip hazard or become 
contaminated. 
• 
Present a risk of strangulation or a tourniquet to patients. 
• 
Rest on or pass over a source of heat. 
• 
Become twisted or trapped under clothing or bandages so that the negative 
pressure is blocked.  
    

 
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6 
EVALUATION METHODOLOGY 
6.1 
ASSESSMENT TIME-POINTS AND DATA RECORDED 
Patients will have 2 Avance® Solo kits available (each with 2 dressings) and data 
will be captured on all dressing changes conducted with these 2 kits.  No 
additional procedures will be carried out, outside of the patient’s standard 
treatment. (for batteries are provided with each pump, additional battery should 
not be required). For the control arm up to 4 products per 14 day period will be 
provided.  
 
At baseline assessment the following parameters will be requested prior to 
application of dressings: 
• 
Treatment setting (Operating room/hospital bed) 
• 
Dressing routinely used (Foam, Film, non-woven, hydrocolloid, alginate, 
other) 
• 
Patient demographics (Age, gender) 
• 
Size of dressing used Type of surgery Date of surgery 
• 
Location of surgical incision site (Left or right side, head/neck, chest, 
back, abdomen, retroperitoneal, groin, upper or lower arm, upper or lower 
leg, other) 
• 
Risk factors for a surgical incision healing complication (obesity, smoker, 
low vascularity, diabetes, radiotherapy, immuno-compromised patient, or 
other) 
• 
Length of incision (cm) 
• 
Method of closure (Sutures, staples, tissue adhesive/glues, skin closure 
tape, other) 
• 
Exudate level (None, slight, moderate, heavy) 
• 
Drain present (yes/no) 
• 
Condition of surrounding skin (Healthy, inflamed, macerated, dry and 
flaky, other) 
• 
Assessment of infection (yes/no)  
• 
Any incision complications and / or clinical signs of infection present 
(None, incision site static or deteriorating, dehiscence, increased 
exudate/secretion levels, increased pain, increased temperature around 
the wound, discolouration of granulation tissue, friable granulation, tissue 
necrosis, local erythema, oedema, purulent drainage, odour, other) 
Photographs (yes/no) 
 
 
At all dressing change assessments the following information will be requested  
• 
Conformability of dressing (yes/no) 
• 
Treatment setting (Operating room, hospital bed, clinic, home, other) 
• 
Size of dressing used  
• 
Photographs (yes/no) 
• 
Pain on application of dressing (None, mild, moderate, severe)  
• 
Ease of use at this assessment 
 
 
At dressing removals the following information will be requested 

 
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• 
Dressing changed since last assessment (yes/no) (if yes how many times has 
the dressing been changed). 
• 
Dressing in place (yes/no) – obtain photograph 
• 
Damage to surrounding skin (none, mild, moderate, severe) 
• 
Level of damage to the reference wound on removal (none, slight, moderate, 
severe) 
• 
Level of damage to the surrounding skin on removal (none, slight, moderate, 
severe) 
• 
Condition of surrounding skin on removal (Healthy, fragile, inflamed, 
macerated, dry and flaky, other)  
• 
Assess closure/ re epithelialisation of the incision 
• 
Patient comfort during wear (Very comfortable, comfortable, acceptable, 
uncomfortable, very uncomfortable) 
• 
Exudate level (None, slight, moderate, heavy) 
• 
Assessment of infection (yes/no) 
• 
Any incision complications and / or clinical signs of infection present (None, 
incision site static or deteriorating, dehiscence, increased exudate/secretion 
levels, 
increased 
pain, 
increased 
temperature 
around 
the 
wound, 
discolouration of granulation tissue, friable granulation, tissue necrosis, local 
erythema, oedema, purulent drainage, odour, other) 
• 
Photographs (yes/no)  
• 
Pain on removal of dressing (None, mild, moderate, severe)  
• 
Reasons for removal (Dressing saturated, strike through, leakage, pain, Fell 
off, removed by patient, suture/staple removal, patients own request, 
inspection prior to patient discharge, other) 
• 
Ease of use at this assessment (only at final removal)  
• 
Occurrence of any product related adverse events will be documented at any 
point during the evaluation if required 
• 
Is another dressing being applied at this assessment (yes / no?) 
 
 
 
At end of evaluation  
• 
Reason for discontinuation (end of evaluation, wound closed, treatment 
interrupted for more than 3 days, Wound progressed sufficiently to 
warrant a change in treatment, patient withdrawn) 
• 
Reason for patient withdrawal (product related adverse event, lack of 
response, poor compliance, patients own request, other) 
• 
Overall acceptability of Avance®Solo to clinicians for indicated use 
(yes/no) 
• 
Whether the clinicians were sufficiently satisfied with the following 
properties of the product overall in terms of: 
 
• 
Exudate management 
• 
Conformability 
• 
Number of dressing changes, strips, pumps, canisters and batteries used 
• 
Barrier to infection 
• 
Condition of surrounding skin 
• 
General (Ease of use, Dressing retention, durability, patient comfort & 
convenience) 

 
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• 
Pain on application of dressing (0-10 SCALE) 
• 
Pain on removal of dressing (0-10 SCALE) 
• 
Overall performance of dressing (1-5) 
• 
Freedom from re-admission 
• 
The use of post operative antibiotics 
• 
The duration of post operative antibiotics if used 
 
 
Comparison of Avance®Solo with HAAMPOD, whether the clinicians were 
satisfied with Avance®Solo compared to HAAMPOD: 
 
• 
Exudate management 
• 
Conformability 
• 
Number of dressing changes 
• 
Barrier to infection 
• 
Condition of surrounding skin 
• 
General (Ease of use, Dressing retention, durability, patient comfort & 
convenience) 
• 
Pain on application of dressing 
• 
Pain on removal of dressing 
• 
Overall performance of dressing 
• 
Use of post operative oral antibiotics 
 
6.2 
PHOTOGRAPHS 
• 
Photographs will be taken with de-indentified periwound stickers;  the patient 
number, date, dressing change number and protocol reference number should be 
entered. The label should be placed so that it lies flat along one of the borders of 
the incision site and not covering any part of the incision.  
• 
When taking photographs ensure that the label details and wound are clearly 
visible and that the wound takes up the majority of the photograph area. 
 
 
7 
ADVERSE EVENTS 
This evaluation is being conducted on a product which is available commercially and 
which is being used within its licensed indications, according to its instructed method 
of use.  In addition, the patient is being treated according to normal practice and no 
invasive or non-routine assessments are being taken.    Therefore, only adverse 
events that are related to the evaluation product are to be reported.  
Adverse Event Reporting. Throughout the Study, Sponsor Investigator agrees to 
procure that any Device Deficiency (“DD”), Adverse Device Effect (“ADE”) and 
Serious Adverse Device Effect (“SADE”) (all as further described in Exhibit A) that 
are considered as being related to the use of the medical device Avance Solo is 
reported in accordance with applicable local and/or regulatory requirements and, in 
addition thereto, be communicated in connection to the regular reports as described 
in clause Error! Reference source not found.. Institution shall ensure that it and the 

 
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Sponsor-Investigator respond promptly to all requests for follow-up information from 
Molnlycke. Institution shall ensure that it and Sponsor-Investigator inform IRB of any 
adverse event, in accordance with the policies and procedures of IRB.” 
A product related adverse event is any untoward medical occurrence which was 
possibly, probably or highly probably caused by the use of the evaluation product.  If 
a product related adverse event occurs the evaluation clinician should complete the 
Clinical Evaluation Adverse Event Form and fax it to the Mӧlnlycke. 
 
8 
STATISTICAL CONSIDERATIONS 
A Chi squared evaluation of the data will be carried out in regard to the 
dichotomous yes/ no variable of post operative wound complication of not.  The two 
groups will be randomized based upon a computer generated randomization 
schedule.  Due to the small numbers the randomization will not be controlled for the 
surgical type.  
 Based upon the current literature the expected wound complication rate of 
the associated wound complication rate would be 16% (or 5/30), based upon best 
treatment effect of NPWTi the rate of wound complication would be 8% or (2/30). 
While this is a clinically significant and cost significant difference, in order to show a 
statistically significant difference at these levels, with an Pβ of 0.8 and a Pα of 0.05, 
the study would have to enroll a cohort of 324 patient with 162 patients in each. To 
date no study of post operative wound dressings has approached this level of 
statistical validity. Prior to embarking on any such study, a pilot study such as this 
needs to be undertaken to validate the basic assumptions. 
Cost analysis of post operative wound complications will not be collected as a portion 
of this data, although LOS and freedom from readmission will be assessed. The data 
set is seen as exploratory and is not powered to find statistical significance.  
9 
ADDITIONAL INFORMATION 
9.1 
RECORD KEEPING 
9.1.1 
Questionnaires 
The questionnaires provided created by the investigator team, and will be 
used to document all findings related to the evaluation. Please complete all questions 
legibly in ink. Where possible  please write any text in English.   
9.1.2 
Evaluation File 
The evaluation file provided by the information technology services at Mount 
Sinai healthcare system, it is a fire wall protected HIPPA.  Evaluation files will not be 
kept on personal computers, thumb drives and will only be used on hospital based IT 
supported systems.  
 

 
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9.2 
EVALUATION PROGRESS UPDATES 
This sponsor can ask for appropriate progress updates during the course of the 
evaluation 
9.3 
USE OF EVALUATION FINDINGS 
The investigator will not use the results of this evaluation without the written consent 
of the Mӧlnlycke, for the purposes of this document e-mail communication is 
equivalent to written consent. 
The goal of the evaluation will be a minimum of an abstract submission at a mutually 
agreed upon national and/or international meeting. 
Secondary goal of the evaluation will be to provide a nidus for publication in and 
national or international journal. 
10 
 
ETHICAL AND LEGAL ISSUES 
10.1 
DECLARATION OF HELSINKI 
The evaluation will be performed in accordance with the guidelines of the Declaration 
of Helsinki (1964) and subsequent revisions.  A copy of the current Declaration of 
Helsinki will be provided if requested by the evaluation Clinician. 
 
10.2 
CONFIDENTIALITY 
The patient will be identified throughout the evaluation and documentation by the 
number allocated to them during the evaluation.  The sponsor will therefore not 
receive any information that could be used to identify patients participating in the 
evaluation. 
 
 
10.3 
INSURANCE 
Product Liability Insurance has been purchased by Mӧlnlycke.  
 
10.4 
 PATIENT CONSENT 
Patients will be screened by the PI, study investigators, and coordinators 
through a medical record review in order to identify potentially eligible patients. Study 
personnel conducting a medical record review for potential subjects will look for 
elements of PHI that will help research personnel determine eligibility (based on the 
inclusion and exclusion criteria listed earlier) and enable them to inform study 
physicians of eligible participants. These identifiers include the following: Names, all 
geographic subdivisions smaller than a state, all elements of dates (except year) for 

 
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dates directly related to an individual, telephone numbers, social security numbers, 
medical records numbers, photographic images and videos of the study wound 
(these images will not contain identifiers). Only these identifiers will be shared with 
the study physicians via email from research personnel to determine if it is 
appropriate to approach the patient about the study. These candidates will be 
identified by study investigators.  
Before being admitted to the clinical evaluation, the patient must have 
consented to the collection of their data during their participation in the evaluation, 
after the nature, scope and possible consequences of the evaluation have been 
explained in an understandable form. Candidates will be consented in a private 
setting and their information will be kept confidential, as only de-identified information 
will be collected from their for the purpose of the study. Subjects will consent to the 
indefinite retention of their de-identified data.  
Although a specific consent form is not being provided for this evaluation, the 
questionnaires contain a space for the evaluation Clinician to sign to confirm that 
they have explained the evaluation to the patient and that the patient has agreed to 
take part.  
For markets or centres where ethics or IRB approval is not required consent 
will still be required.  Where ethics or IRB is required an approved consent form will 
be used. 
The Clinician will not undertake any measures relating to the evaluation until consent 
has been obtained. 
After consent is obtained, data will be collected from the EMR, study specific 
procedures, and the patient to complete screening, follow-up and final visit 
documentation, as well as the patient satisfaction questionnaire.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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References 
1. Horch RE. Incisional negative pressure wound therapy for high-risk wounds. J 
Wound Care. 2015 Apr;24(4 Suppl):21-8. doi: 
10.12968/jowc.2015.24.Sup4b.21. PMID: 25853645. 
 
2. Brandon T. A portable, disposable system for negative-pressure wound 
therapy. Br J Nurs. 2015 Jan 22-Feb 11;24(2):98, 100-6. doi: 
10.12968/bjon.2015.24.2.98. PMID: 25615995. 
 
3. Pachowsky, M., Gusinde, J., Klein, A., Lehrl, S., Schulz-Drost, S., 
Schlechtweg, P., Pauser, J., et al. (2011). Negative pressure wound therapy 
to prevent seromas and treat surgical incisions after total hip arthroplasty. 
International orthopaedics. doi:10.1007/s00264-011-1321-8 
 
4. Stannard, J, et al, Incisional Negative Pressure Wound Therapy After High-
Risk Lower Extremity Fractures; Journal of Orthopaedic Trauma, 260 (1), 106