Peripheral Catheter Pressure Ulcer Prevention in Pediatry : Use of Compresses Versus Standard Care"
Phase: NA
Conditions: Pressure Ulcer
Sponsor: Centre Hospitalier Departemental Vendee

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KTESCA Protocol 
 
 
Registration number: No. 2020-A00366-33 
Ref: CHD194-19 
NCT number: 04540822 
 
"Prevention of pressure ulcers during peripheral catheter 
maintenance in paediatrics: use of compresses versus standard 
care" 
 
 
 
Coordinating Investigator:   
Stéphanie BREHU 
Healthcare Manager 
Health Professions Training Institute 
33 Rue du Maréchal Koenig 
CHD Vendée 
85000 La Roche sur Yon  
stephanie.brehu@ght85.fr 
 
 
 
 
 
     02 53 07 62 46 
 
 
 
 
 
Methodologist: 
 
Lucie PLANCHE 
Vendée Departmental Hospital Centre 
Clinical Research Unit 
lucie.planche@chd-vendee.fr 
 
 
 
Sponsor:  
   Vendée Departmental Hospital Centre 
Clinical Research Unit 
Boulevard Stéphane MOREAU 
85 925 LA ROCHE SUR YON Cedex 09 
Tel: 02 51 44 65 72 
Fax: 02 51 44 65 85 
 
 
 
 
 
 
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SIGNATURE PAGE 
 
 
SIGNATURE OF THE PROMOTER 
 
The sponsor undertakes to conduct this study in accordance with all legislative and regulatory 
provisions applicable to the research and in accordance with the protocol. 
 
Name and position of the signatory 
representative: 
For the sponsor and by delegation 
from the Chief Executive Officer, the 
Director of Medical Affairs and 
Research 
 
Date: 
 
Signature: 
 
 
INVESTIGATOR'S SIGNATURE  S 
I have read all the pages of the clinical trial protocol sponsored by CHD Vendée. I confirm that 
it contains all the information necessary to conduct the trial. I undertake to conduct the trial in 
accordance with the protocol and the terms and conditions set out therein. I undertake to conduct 
the trial in accordance with: 
 
❖ the principles of the "Declaration of Helsinki",  
❖ the rules and recommendations of international (ICH) and French (rules of good clinical 
practice for biomedical research involving medicinal products for human use) good 
clinical practice 
❖ European regulations and/or national legislation and regulations relating to clinical trials, 
 
I also undertake to ensure that investigators and other qualified members of my team have 
access to this protocol and to the documents relating to the conduct of the trial so that they can 
work in accordance with the provisions contained in these documents. 
 
Coordinating 
investigator 
Surname: 
 
 
 
 
 
 
Date: 
Signature: 
Principal 
Investigator 
Name and institution: 
 
 
 
 
 
Date: 
Signature: 

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LIST OF ABBREVIATIONS 
 
 
ANSM 
French National Agency for Medicines and Health Products Safety 
ARC 
Clinical Research Associate (monitor) 
GCP 
Good Clinical Practice 
CHD 
Departmental hospital centre 
CPP 
Committee for the Protection of Individuals  
CNIL 
National Commission for Information Technology and Civil Liberties 
CRF 
Case Report Form 
DM 
Medical Devices 
eCRF 
Electronic Case Report Form 
EPUAP 
European Pressure Ulcer Advisory Panel 
EvIG  
Serious Adverse Event 
ICH 
International Conference on Harmonisation 
IDE 
State-registered nurse 
MR 
Reference Methodology CNIL 
NPUAP 
National Pressure Ulcer Advisory Panel 
TEC 
Clinical Research Technician 
PIV 
Peripheral Venous Access 
 
 
 

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TABLE OF CONTENTS 
 
SIGNATURE PAGE ................................................................................................................................... 2 
LIST OF ABBREVIATIONS ..................................................................................................................... 3 
INTRODUCTION ....................................................................................................................................... 5 
1. 
JUSTIFICATION FOR THE STUDY .............................................................................................. 6 
1.1. 
POSITIONING OF THE RESEARCH .................................................................................................... 6 
1.2. 
BENEFITS AND RISKS FOR RESEARCH PARTICIPANTS .................................................................. 10 
2. 
OBJECTIVES AND EVALUATION CRITERIA ......................................................................... 12 
2.1. 
PRIMARY OBJECTIVE AND ENDPOINT .......................................................................................... 12 
2.2. 
SECONDARY OBJECTIVES AND EVALUATION CRITERIA ............................................................... 12 
3. 
STUDY POPULATION .................................................................................................................... 14 
3.1. 
DESCRIPTION OF THE POPULATION .............................................................................................. 14 
3.2. 
INCLUSION CRITERIA ................................................................................................................... 14 
3.3. 
EXCLUSION CRITERIA .................................................................................................................. 14 
4. 
DESIGN AND CONDUCT OF THE STUDY ................................................................................ 16 
4.1. 
STUDY SCHEDULE ........................................................................................................................ 16 
4.2. 
GENERAL RESEARCH METHODOLOGY ......................................................................................... 18 
4.3. 
STUDY DESIGN ............................................................................................................................. 18 
4.4. 
DESCRIPTION OF THE INTERVENTION STUDIED ........................................................................... 19 
4.5. 
DESCRIPTION OF THE EVALUATION AND DATA COLLECTED ....................................................... 20 
4.6. 
IDENTIFICATION OF ALL SOURCE DATA NOT INCLUDED IN THE MEDICAL RECORD ..................... 22 
4.7. 
RULES FOR DISCONTINUING A PERSON'S PARTICIPATION ............................................................ 23 
5. 
DATA MANAGEMENT AND STATISTICS ................................................................................ 25 
5.1. 
COLLECTION AND PROCESSING OF STUDY DATA ......................................................................... 25 
5.2. 
STATISTICS .................................................................................................................................. 26 
6. 
SAFETY EVALUATION ................................................................................................................. 30 
7. 
ADMINISTRATIVE AND REGULATORY ASPECTS ............................................................... 31 
7.1. 
RIGHT OF ACCESS TO SOURCE DATA AND DOCUMENTS ............................................................... 31 
7.2. 
DATA CONFIDENTIALITY ............................................................................................................. 31 
7.3. 
COMPUTERISED DATA AND SUBMISSION TO THE CNIL ............................................................... 31 
7.4. 
TRIAL MONITORING ..................................................................................................................... 32 
7.5. 
INSPECTION/AUDIT ...................................................................................................................... 32 
7.6. 
ETHICAL CONSIDERATIONS ......................................................................................................... 32 
7.7. 
INFORMATION TO THE COMPETENT AUTHORITIES ....................................................................... 34 
7.8. 
AMENDMENTS TO THE PROTOCOL ............................................................................................... 34 
7.9. 
FUNDING AND INSURANCE .......................................................................................................... 35 
7.10. 
RULES ON PUBLICATION .......................................................................................................... 35 
7.11. 
DISPOSAL OF BIOLOGICAL SAMPLES ........................................................................................ 35 
7.12. 
ARCHIVING OF SOURCE DATA .................................................................................................. 36 
8. 
BIBLIOGRAPHICAL REFERENCES ........................................................................................... 37 
LIST OF APPENDICES ........................................................................................................................... 39 
 
 
 

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INTRODUCTION 
 
Children and adolescents require specific care. Treatments, therapeutic strategies and medical 
devices cannot always be identical to those used for adults, as they are not always suitable for 
this population. This leads us to regularly reflect on our professional practices. 
Our specific role as nurses or paediatric nurses within a multi-disciplinary paediatric department 
is to be as responsive as possible to the needs of this population.  
The insertion of peripheral venous catheters is a daily practice in the department. 
Within the multidisciplinary team, we have observed for several years the appearance of skin 
lesions similar to bedsores at the junction of the peripheral venous catheter and the extension 
tube. A practice has spontaneously developed within the department of placing a compress under 
this junction. The aim is to minimise physical or emotional distress and pain. Pain is a priority in 
the care of children and adolescents. Pain that is denied or unidentified and not relieved is 
remembered by the child, which can have consequences on their perception of pain and their 
subsequent acceptance of care. 
To date, through our reading and research, we have found articles mentioning the risk of pressure 
sores in children associated with medical devices. However, little information is available on 
pressure sores associated with catheters, particularly on this specific technique for preventing 
lesions at the catheter-extension junction.  
The aim of this study is therefore to compare two peripheral venous catheter fixation devices, with 
and without compresses, and to analyse the frequency of pressure ulcer occurrence and the 
severity of this injury. 
 
 
 

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1. JUSTIFICATION FOR THE STUDY 
1.1. 
POSITIONING OF THE RESEARCH 
The insertion of peripheral venous catheters is a daily practice in paediatric and neonatal wards.  
On average, more than 25 million peripheral venous catheters are inserted annually in France in 
all healthcare departments combined (1). 
These catheters enable the administration of intravenous treatments (isotonic solutions, 
antibiotics, injectable drugs, etc.) as well as the collection of blood for analysis. 
 
In departments such as paediatrics, these peripheral venous catheters can be difficult to insert 
due to the small venous capacity associated with the child's age. The difficulty increases when 
the child is afraid of needles or has had bad experiences, as anxiety activates the sympathetic 
nervous system, causing local peripheral vasoconstriction (2). Maintaining peripheral venous 
access (PVA) over time is also difficult due to children's mobility. In fact, 5% of peripheral venous 
catheters are accidentally removed in children (3). 
For all these reasons and in accordance with HAS recommendations, there is no maximum 
duration for maintaining PIVCs in children (4) and nursing supervision is very important. 
 
The routine use of peripheral venous catheters exposes children to iatrogenic risks such as severe 
skin damage. Approximately three-quarters of children hospitalised in paediatric wards are fitted 
with a peripheral or central venous catheter, with a rate of adverse events associated with care 
reaching up to 80%. However, this rate remains difficult to determine due to variations in the 
definition of a complication (5). 
In 35% of cases, PIVCs are removed due to complications: infiltration (extravasation) 14.4%, 
occlusion 13.4%, signs of thrombophlebitis 7%, suspected infection 0.3%, wounds and injuries at 
the puncture site 0.2% (6). 
 
Registered nurses, thanks to their experience and skills, play a fundamental role in the 
maintenance of peripheral venous catheters. Observation of puncture sites and monitoring of the 
complications mentioned above are well established in nursing practice. 
 
For several years, we have observed skin changes such as redness and bedsores at the junction 
of the catheter and the peripheral venous line extender when removing peripheral venous 
catheters in our paediatric department. This junction between the catheter and the extension tube 

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is more prominent and is pressed against the skin by the occlusive dressing used to maintain the 
PIV. Regardless of the type of equipment used and the brand, this junction is always present.  
These pressure sores, which can cause pain and scarring on a child's skin, are difficult for a nurse 
to detect (before removing the PIVC) because they are located under the medical device and the 
fixation device. 
In addition, the specific nature of paediatrics can make pressure sores difficult to detect. One of 
the main reasons for this is the difficulty of communicating with children about pain and discomfort. 
 
A pressure ulcer is an ischaemic lesion caused by compression of soft tissue between a hard 
surface and a bony prominence (7). This prolonged compression causes tissue ischaemia. 
There are many risk factors for pressure ulcers, which are well described by the EPUAP 
(European Pressure Ulcer Advisory Panel) and the NPUAP (National Pressure Ulcer Advisory 
Panel) in their abbreviated reference guide (8). 
These include intrinsic factors such as the child's age (level of activity and mobility, skin maturity), 
nutritional status, peripheral perfusion disorders, certain acute or chronic serious illnesses, and 
treatments. 
 
Other factors, known as extrinsic or mechanical factors, such as pressure, friction, shear and 
maceration, are also known to cause pressure ulcers. 
In our case, the pressure sores observed at the junction of the catheter and the peripheral venous 
line extender are mainly related to these extrinsic factors. These are referred to as iatrogenic 
pressure sores. 
Numerous articles mention the fact that children fitted with medical devices are at risk of pressure 
ulcers. A separate section is devoted to them in the NPUAP's reference guide on the prevention 
and treatment of pressure ulcers (8). 
It also specifies that pressure ulcers associated with medical devices are less studied in children 
than in adults. 
 
To assess the risk of pressure ulcers in adults, there is a reference assessment scale, the Braden 
Q scale. This scale is also recommended for children to assess the risk of pressure ulcers related 
to medical devices. (9) 
In a 2017 study, 8% of hospitalised children developed pressure ulcers, 2% of which were related 
to immobility and 6% to medical devices. (9) 
In a 2013 article in the Paediatric Journal (10), various medical devices responsible for pressure 
ulcers are listed, such as intubation tubes, drains, orthopaedic splints, nasogastric tubes, 
oxygenation systems and intravenous catheters. Clinicians have identified that MDs positioned in 
contact with the skin can lead to the development of pressure ulcers. Although the aetiology of 

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pressure ulcers related to immobility and those related to MDs is different, the mechanism of 
wound formation is similar. 
Few articles specifically discuss pressure ulcers associated with VVP. 
 
These pressure ulcers associated with medical devices are not without consequences for children. 
In addition to skin damage, there is also psychological trauma related to the care and pain caused 
by the bedsore, which can make future treatment difficult (10). 
 
An international classification system for pressure ulcer stages was established in 1998 by the 
National Pressure Ulcer Advisory Panel (8). This scale, which was initially validated on an adult 
population, is perfectly applicable to the classification of pressure ulcers in children.  
Paediatric nurses use it systematically when removing catheters to assess the stage of the 
pressure ulcer. The pressure ulcers observed in our department and linked to the junction 
between the catheter and the extension tube are mainly stage I pressure ulcers. 
 
In order to limit the occurrence of these pressure ulcers, specific recommendations are described 
by the NPUAP (8). These primarily concern the selection and assembly of the medical device. 
The device must be examined and selected within the institution so that the pressure and shear 
forces cause as little damage as possible. It must be used correctly in accordance with the 
manufacturer's specifications.  
In addition, the skin and medical device must be inspected at least twice a day.  
It is also recommended to keep the skin under the medical devices clean and dry and to use 
prophylactic dressings to reduce pressure at the skin-device interface. 
As soon as medically possible, all medical devices that are a potential source of pressure sores 
should be removed. 
 
In the Paediatrics Department at CHD Vendée, we try to follow these recommendations as closely 
as possible.  
The equipment is selected by the pharmacy and the medical devices team.  
Nurses are trained in pressure ulcer monitoring and ensure that VVP is monitored each time they 
visit, i.e. more than twice a day. Skin monitoring at the junction is limited because the catheter is 
held in place by a sterile occlusive dressing that cannot be changed at each monitoring session 
due to the risk of infection. In addition, the child's lack of cooperation and mobility can make care 
difficult. PIVCs in children are considered by nurses to be valuable medical devices for the child's 
recovery. 
 

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Following the observation of skin lesions at the catheter-extender junction in the department, a 
protocol for peripheral venous catheter placement was developed by the team and validated by 
the hygiene department of the CHD Vendée hospital. It stipulates the placement of a sterile 
compress cut to size under the hard parts of the medical device (at the catheter/extension junction) 
covered with a sterile transparent adhesive dressing. The choice of sterile compress is based on 
the fact that this type of dressing is readily available (a pack of sterile compresses is required for 
skin disinfection before catheter insertion) and inexpensive. The nurse must cut the compress in 
advance with sterile scissors to protect the area of contact between the skin and the medical 
device.  
 
This practice was also recommended at the Pédiadol congress (11). To our knowledge, it is not 
widely used. We are only aware of practices in the paediatric intensive care unit at Trousseau 
Hospital, where a compress or thick hydrocolloid dressing is placed under the catheter and under 
hard areas to prevent pressure sores associated with medical devices. (12) 
The application of these prophylactic dressings when inserting a PIVC is not taught to future 
healthcare professionals during their training at the Institute for the Training of Healthcare 
Professionals. 
The latest SF2H recommendations from May 2019(13) on the placement and maintenance of 
peripheral venous catheters provide detailed information on infection prevention, but there are no 
recommendations on pressure ulcer prevention. 
 
To date, no study has been published on this practice, which, if proven effective, would deserve 
to be more widely disseminated. 
We therefore wish to conduct a controlled, randomised study to evaluate the benefits of 
compresses in the prevention of pressure ulcers associated with peripheral venous catheters. 
This single-centre study will be a pilot study that will provide data that can then be used to consider 
a larger multicentre study if the compress proves to be an effective and safe tool in the prevention 
of pressure ulcers. 

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1.2. 
BENEFITS AND RISKS FOR RESEARCH PARTICIPANTS 
1.2.1. 
Benefits 
1.2.1.1. 
Individual benefit 
If the hypothesis proves correct, participating in this study will enable patients in the "PIVC with 
compress" arm to reduce their risk of developing pressure ulcer-type skin lesions. 
Pain and skin damage caused by pressure on this junction can be reduced. This practice would 
make it easier for children to accept treatment and limit the trauma of infusion.  
Patients included in the "VVP without compress" arm will receive standard care in other 
departments and hospitals. 
1.2.1.2. 
Collective benefit 
A collective benefit can be envisaged in terms of harmonising practices within different 
departments and hospitals. Better prevention of pressure sores associated with the placement 
and maintenance of VVP would enable compliance with NPUAP recommendations, namely to 
minimise the risk of pressure sores associated with medical devices. It would also reduce sources 
of pain. 
1.2.2. 
Risks 
1.2.2.1. 
Individual risk 
The placement of VVP exposes patients to a risk related to the presence of medical devices: 
 
- 
The risk of pressure ulcers exists in both groups; 
- 
A minor risk of infection cannot be ruled out due to the presence of a dressing if it is soiled. 
Multiple daily monitoring by caregivers greatly minimises this risk. 
1.1.2.2 Collective risk 
Placing a compress under the catheter device does not present any collective risk except for an 
additional cost (sterile compress and scissors). 

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1.2.3. 
Benefit/risk balance 
The research manager classifies this research as minimally risky and minimally restrictive 
interventional research, since: 
✓ 
All procedures are performed in the usual manner and are defined in the decree of 12 April 
2018 issued by the Ministry.  
In fact, VVP placement is performed several times a day by registered nurses in the Paediatrics 
Department of the CHD Vendée hospital in La Roche-sur-Yon. 
 Furthermore, there are no recommendations regarding the choice of type of pressure ulcer 
prevention under medical devices. 
The research does not focus on techniques or strategies that are either innovative or obsolete. 
 
All patient care will be identical to usual practice. In particular, the discharge date will be decided 
by the doctor in charge of the patient, independently of the study, but will be recorded in the 
patient's file and the research CRF. 
 
Consequently, the specific implementation procedures in the research represent negligible 
constraints for the person participating in the research. (Article R 1121-3 of the Public Health Code 
(CSP), Decree No. 2006-477 of 26 April 2006) 
The research manager shall therefore submit, prior to any implementation of the research, for a 
favourable opinion and confirmation of the research's eligibility, the study protocol to the 
Committee for the Protection of Persons in accordance with Article L 1121-1 of the Public Health 
Code (CSP) as resulting from Laws No. 2004-806 of 9 August 2004 and No. 2006-450 of 18 April 
2006 relating to public health policy. 
Bibliographical references are listed in section 8 of the document. 

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2. OBJECTIVES AND ASSESSMENT CRITERIA 
2.1. 
OBJECTIVE AND MAIN ASSESSMENT CRITERION 
2.1.1. 
Primary objective 
Compare the incidence of pressure sores during standard fixation versus fixation with a compress 
at the junction between the catheter and the extension tube in a paediatric population. 
2.1.2. 
Primary assessment criterion 
The primary endpoint is the occurrence of pressure ulcers of grade >=1 on the NPUAP scale at 
the catheter/extender junction. The assessment will be carried out blind by a childcare assistant 
from the department. 
2.2. 
SECONDARY OBJECTIVES AND EVALUATION CRITERIA 
2.2.1. 
Secondary objective(s) 
- Compare the severity of pressure ulcers at the catheter/tube junction. 
 
- Compare the duration of peripheral venous catheter retention between the two groups. 
 
- Compare the rate of nosocomial infections related to peripheral venous catheters between the 
two groups. 
2.2.2. 
Secondary evaluation criteria 
- The severity of pressure ulcers will be assessed using the NPUAP scale 
 

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- The duration of catheter retention will be calculated between the time the catheter is inserted 
and the time it is removed. 
 
- The presence of a nosocomial infection related to the peripheral venous catheter. 
This will be defined by a peripheral venous catheter culture >103CFU/ml, if the peripheral venous 
catheter is sent for culture due to suspected infection and in the absence of antibiotic treatment. 
In the presence of antibiotic treatment, it will be defined by the presence of pus and/or regression 
of infectious signs within 48 hours of removal of the peripheral venous catheter. 
 
 
 

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3. STUDY POPULATION 
3.1. 
DESCRIPTION OF THE POPULATION 
The study plans to include 396 patients with the aim of obtaining 360 randomised patients (see 
section 5.2.1 Description of planned statistical methods). 
Inclusions will cease when the potential number of randomised patients has been reached.  
 
Patients will be children aged between 1 month and 18 years, hospitalised in the General 
Paediatrics Department of the CHD Vendée hospital in La Roche-sur-Yon, or with a high 
probability of being hospitalised in Paediatrics following a visit to the Paediatric Emergency 
Department, for whom there is an indication for the insertion of a peripheral venous catheter. 
 
We have chosen the age range of 1 month to 18 years because it appears that the skin is immature 
before 3-4 weeks of life and therefore at greater risk of iatrogenic skin lesions, according to the 
French Society of Dermatology (14). 
As the patients are minors, prior authorisation will be sought from their parents. 
3.2. 
INCLUSION CRITERIA 
Patient: 
• 
Aged between 1 month and 18 years, according to the admission criteria of the 
paediatric department of the CHD La Roche sur Yon. 
• 
Hospitalised in paediatrics or attending the paediatric emergency department with a high 
probability of subsequent hospitalisation in paediatrics. 
• 
With an indication for the insertion of a short peripheral venous catheter 
• 
Written consent of the person(s) with parental authority  
3.3. 
EXCLUSION CRITERIA 
• 
Children with pre-existing skin conditions at the time of inclusion and at the puncture site 
(atopic dermatitis, skin infection, skin wound, chickenpox, epidermolysis bullosa) 

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• 
Allergy to fixation devices 
• 
Known immunocompromised children 
• 
Refusal of the patient or legal guardians to participate in the project 
• 
Emergency life-saving treatment 
• 
Patient already included in the study 
• 
Patient without social security coverage 
 

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4. DESIGN AND CONDUCT OF THE STUDY 
4.1. 
STUDY SCHEDULE 
• 
Recruitment period: 48 months 
• 
Duration of patient participation in the study: until catheter removal. 
 
a) Inclusion 
 
Information and verbal consent regarding participation in the study will be obtained from the minor 
patient. Consent will be signed by the person(s) with parental authority (see 7.6.1: special case of 
the presence of only one parent). 
 
This will be done once the medical prescription for peripheral venous access has been issued, 
the inclusion and exclusion criteria have been verified, and before randomisation. 
 
The patient will be: 
• 
either in the paediatric emergency department; 
• 
or already hospitalised in paediatrics; 
 
A table tracking patients to whom the study has been proposed will be kept up to date, noting the 
reasons for non-inclusion and refusals to participate. 
 
b) Randomisation 
 
Once consent to participate has been obtained, randomisation will be carried out via the 
computerised data base (eCRF): 
 
• 
VVP placement without compress group: reference strategy group. 
• 
VVP placement with compress group: alternative strategy group. 
 
The peripheral venous line will then be placed according to the group designated by 
randomisation. 
Details of the procedure for each arm are described in 4.4. 
c) Follow-up 

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In both groups, catheter management and maintenance will be carried out by the nursing team 
responsible for the patient in the paediatric ward in accordance with current institutional 
procedures (see Appendices 1 and 2, catheter placement protocol with and without compress). 
 
Data will be collected at the time of PPV removal. The peripheral line placed is valuable. In 
practice, the lines are maintained until the end of treatment unless there is redness and/or 
discharge at the puncture site. 
 
When the catheter is removed, the nurse in charge of the patient removes the crepe bandage, the 
compress if there is one, and the catheter.  
 
A childcare assistant from the department who has not been caring for the patient will then be 
called to assess the condition of the skin and report on the appearance and grade of any bedsores. 
The nurse will also note the presence or absence of signs of infection according to the Maddox 
scale. If the index is greater than 3, the paediatrician will prescribe that the catheter be sent for 
culture. 
The microbiological analysis will be carried out by the clinical research biology team at the CHD 
Vendée. 
 
d) Study design 
Actions 
D0 
(Inclusion visit) 
Every day 
 
J Withdrawal 
from the VVP 
Patient information 
X 
 
 
Informed 
consent from the 
patient 
(verbal) + legal guardian (written) 
X 
 
 
Randomisation  
X 
 
 
Peripheral venous access 
X 
 
 
Monitoring of puncture site (catheter sent 
for culture if local infection) 
 
X 
 
Assessment of the presence of a lesion + 
severity of the lesion by a childcare 
assistant 
 
 
 
X 
 

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4.2. 
GENERAL RESEARCH METHODOLOGY 
The research has the following characteristics:  
❖ Single-centre 
❖ Open  
❖ With blinded assessment of the primary endpoint 
❖ Controlled 
❖ Randomised into 2 parallel groups:  
• 
Placement of VVP with a compress under the catheter/tubing junction 
• 
Standard VVP placement, without pad under the tubing 
4.3. 
STUDY DESIGN 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Indication for VVP placement 
Randomisation 
Placement of a VVP with a 
compress under the catheter-
extension junction 
Consent and inclusion 
Inclusion criteria met 
Placement of a VVP without 
a compress under the 
catheter-extension junction 
Assessment of pressure ulcer after catheter 
removal by a nursing assistant blinded to the 
randomisation arm 
Multiple daily monitoring of the 
puncture site 

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4.4. 
DESCRIPTION OF THE INTERVENTION STUDIED 
The method consists of inserting a BD Insyte® catheter, gauge 20 to 24G, into a peripheral vein 
located in the crook of the elbow, the back of the hand, the scalp or the top of the foot. 
The catheter is inserted after cleansing and disinfecting the skin with appropriate products and in 
accordance with the procedure in force in the department (see Appendices 1 and 2). 
Once venous return has been verified, a 10 cm extension tube with a BECTON-DIC® 3-way 
stopcock is connected, which has been previously purged with 0.9% sodium chloride. 
 
This catheter will be used as an access route for hydration (Polyionique®, G5% or G10% and 
NaCl), antibiotic therapy, analgesia, blood products or labile blood products.   
Not all vein-toxic products such as chemotherapy drugs will be injected via these catheters, as 
they are administered via central venous lines. 
 
We currently have 10 cm extension tubes with BECTON-DIC® three-way stopcocks. We are 
unable to predict future markets during our study. 
There will inevitably be an extension catheter junction that will enable us to maintain our 
monitoring in connection with our study. 
 
For patients with "VPP arm with compress": 
A sterile non-woven compress, cut under sterile conditions (3.5 x 1.5 cm), will be inserted under 
the catheter-extension junction. The assembly will be held in place by a sterile, semi-permeable 
transparent adhesive dressing such as Tégaderm® (5 x 7 cm) or Oper film 6 x 7 cm. 
This area will be secured by applying a crepe bandage (4 m x 7 cm). This will enable the childcare 
assistant to maintain a blind assessment of the primary endpoint. 
 

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The study will focus on the evaluation of a single catheter placed per patient.  
If several catheters are placed, only the first device will be evaluated and monitored until its 
removal. 
With regard to the duration of use, the SF2H recommendations (13) will be applied, i.e. no catheter 
changes will be made if good patency and asepsis are maintained until the end of treatment. 
4.5. 
DESCRIPTION OF THE EVALUATION AND DATA COLLECTED 
The primary endpoint is the development of a pressure ulcer of grade ≥1 on the NPUAP scale at 
the catheter/tubing junction. 
 
 
 
Monitoring area 
Puncture site 
Compress under 
the screw 
connection at the 
junction of the 
catheter and

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This area is assessed several times a day by nurses, who remove the bandage without removing 
the fixation device (compress and transparent adhesive dressing). However, if the compress is 
soiled, the dressing will be changed. 
 
NPUAP scale 
 
The NPUAP pressure ulcer assessment scale, translated from English by ANAES, will be used. 
This scale allows pressure ulcers to be assessed according to four stages, graded from 1 to 4, 
with stage 1 being the least severe. 
 
• 
Stage I: The first stage is an observable change in intact skin, related to pressure and 
manifested by a change in one or more of the following characteristics compared to the 
adjacent or contralateral body area: skin temperature (warm or cold), tissue consistency 
(firm or soft) and/or sensitivity (pain, itching). In people with fair skin, the pressure ulcer 
appears as persistent localised redness, while in people with pigmented skin, the pressure 
ulcer may be a persistent red, blue or purplish colour. 
 
 
 
• 
Stage II: Loss of part of the skin's thickness; this loss affects the epidermis, the dermis, or 
both. The pressure ulcer is superficial and clinically presents as an abrasion, blister, or 
shallow ulceration.  
 
Example: Stage 1 pressure ulcer 

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• 
Stage III: Loss of all skin thickness with alteration or necrosis of the subcutaneous tissue; 
this may extend to the fascia, but not beyond. The pressure ulcer appears clinically as a 
deep ulceration with or without invasion of surrounding tissues.  
 
• 
Stage IV: Loss of the entire thickness of the skin with significant tissue destruction, or 
involvement of muscles, bones, or supporting structures (e.g., tendons, joints). Invasion 
and fistulas may be associated with stage IV pressure ulcers. 
 
The catheter will be removed by the nurse in charge of the patient. 
 
In order to allow for a blind assessment of the primary endpoint, this will be performed by a 
childcare assistant from the department who is on duty 24 hours a day and has not previously 
cared for the child. The childcare assistant will assess the pressure area and then note their 
observations in the patient's file (presence or absence of pressure ulcers and NPUAP grade, if 
applicable). 
 
An assessment based on photographs was initially considered, but given the description of the 
different stages (particularly stage I, characterised by persistent redness), we believe that a direct 
assessment by a professional is more appropriate. Furthermore, a 2013 study concluded that 
assessment based on photographs is not sufficient for an accurate assessment of the stage of 
pressure ulcers (15). 
Maddox Scale 
 
This scale will be used to monitor for any signs of infection at the puncture site. 
 
We have chosen not to include pain assessment as an endpoint criterion, as it is difficult to assess 
pain specifically related to the medical device in this population. 
4.6. 
IDENTIFICATION OF ALL SOURCE DATA NOT INCLUDED IN THE 
MEDICAL RECORD 
Source data not included in the medical record corresponds to data not routinely collected in the 
medical and paramedical records. 
In this study: The assessment by the childcare assistant of the grade of pressure ulcer reported 
on a data collection sheet will be considered as the source data. 

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4.7. 
RULES FOR DISCONTINUING A PERSON'S PARTICIPATION 
4.7.1. 
Criteria for premature termination of a person's 
participation in the research 
Subjects may withdraw their consent and request to leave the study at any time and for any 
reason. In the event of premature withdrawal, the investigator must document the reasons as fully 
as possible. 
The investigator may temporarily or permanently discontinue a subject's participation in the study 
for any reason that is in the best interests of the subject, particularly in the event of serious adverse 
events. 
4.7.2. 
Procedures for premature termination of a person's 
participation in research 
In the event of withdrawal of consent, data already collected may be analysed unless the patient 
objects. 
Their medical care will be identical to the usual care provided to this type of patient in the 
department. 
 
The information to be collected is: 
o Date of end-of-study visit  
o Reason for early withdrawal 
 
For information on how data from individuals who withdrew prematurely from the study will be 
used, please refer to the statistics section. 
4.7.3. 
Criteria for discontinuing part or all of the research 
(excluding biostatistical considerations) 
The CHD de Vendée reserves the right to interrupt the study at any time if it appears that the 
inclusion objectives are not being met. 
 

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Part or all of the study may be terminated permanently or temporarily by decision of the ANSM, 
the CPP or the study sponsor. 
 
Written confirmation will be sent to the study coordinator (specifying the reasons for premature 
termination). 

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5. DATA MANAGEMENT AND STATISTICS 
5.1. 
COLLECTION AND PROCESSING OF STUDY DATA 
5.1.1. 
Data collection 
An electronic case report form (eCRF) will be created for each patient. All information required by 
the protocol must be provided in the eCRF. It must include the data necessary to confirm 
compliance with the protocol and all data necessary for statistical analysis; it must allow for the 
detection of major deviations from the protocol. 
 
The persons responsible for completing the eCRFs (investigator, ARC, etc.) must be defined and 
identified in the table of delegated responsibilities (kept in the investigator's binder). 
5.1.2. 
Data coding 
By signing this protocol, the principal investigator and all co-investigators undertake to keep the 
identities of the patients who participated in the study confidential.  
 
The transmission of an individual's data for research purposes will therefore only be possible 
subject to the application of a coding system; the presentation of research results must exclude 
any direct or indirect identification. 
 
Patients will be identified according to the order of patient inclusion by a number automatically 
assigned by the Clinsight software (eCRF) and then supplemented by the patients' initials. 
 
This code will be the only information appearing on the eCRF that will allow the eCRF to be linked 
to the patient at a later date.  
The research manager is also required to code patient data on all documents in their possession 
that may be attached to the CRF. 
 
A correspondence table will be set up at the centre. This table will be kept in a secure location by 
the centre's principal investigator and will contain the patient code and their personal data , so 

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that the patient file can be traced in the event of missing or incorrect data. No clinical data will be 
collected in these correspondence tables. 
5.1.3. 
Data processing 
Clinical data will be collected using a database and data entry forms modelled on the observation 
log, in accordance with the protocol and current regulations. 
5.2. 
STATISTICS 
Responsible for statistical analysis: 
 
Lucie Planche 
Vendée Departmental Hospital Centre 
Clinical Research Unit 
lucie.planche@chd-vendee.fr 
 
Software 
The analyses will be performed using R software version 3.5.1 
5.2.1. 
Description of planned statistical methods, including 
the schedule for planned interim analyses 
All variables will be described globally and by group. The description will include the numbers and 
percentages of modalities for qualitative variables and the minimum, maximum, mean, standard 
deviation and median for quantitative variables. 
 
 

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Primary endpoint 
The primary endpoint is defined as the presence of a pressure ulcer at the junction of the catheter 
with the extension tube or peripheral venous line tubing. The assessment will be performed upon 
catheter removal and blinded by a nursing assistant from the department. 
The percentage of patients will be presented with a 95% confidence interval in the two groups and 
will be compared using a Chi-square test. 
 
In a second step, the two groups will be compared using logistic regression to take into account 
the duration of catheter retention. 
 
Secondary criteria 
 
The severity of pressure ulcers will be described between the two groups. At each stage of the 
NPUAP scale, the number and percentage of patients will be presented. A Mann-Whitney test will 
be applied to compare the two groups. 
 
The average duration of catheter retention will be described for the two groups with a 95% 
confidence interval. It will be compared using a Student's t-test. 
 
The number of patients with nosocomial infection will be described in the two groups. No statistical 
test will be performed. 
5.2.2. 
Statistical justification of the number of subjects 
This is a pilot study. To our knowledge, there are currently no data on the assessment of pressure 
ulcers at the junction of the catheter with the extension tube or peripheral venous line tubing in 
paediatric hospitalised patients. 
This study will therefore provide reliable data on these pressure ulcers in both standard care 
(without compresses) and will also provide data on the benefits of compresses for pressure ulcer 
prevention.  
 
With a total of 346 patients, our study will highlight a difference of at least 15% between the two 
groups (80% power and 5% alpha risk). In order to guarantee the power of the study, a total 
of 360 patients will be randomised. 

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5.2.3. 
Expected degree of statistical significance 
The alpha risk is set at 5%. 
5.2.4. 
Statistical criteria for stopping the research 
NA 
5.2.5. 
Method for handling missing, unused or invalid data 
All missing data and the reasons for their absence will be described in each group. 
 
For the analysis of the primary endpoint, in the event of missing data, we will consider the absence 
of pressure ulcers (regardless of the randomisation group). 
5.2.6. 
Management of changes to the initial strategy analysis 
plan 
NA 
5.2.7. 
Selection of individuals to be included in the analyses 
The primary analysis will be performed on the intention-to-treat (ITT) population, i.e. all 
randomised patients. 
 
A complementary analysis will be performed on the Per Protocol (PP) population, including 
randomised patients for whom no major deviations from the protocol have been identified. 
A data review meeting will be organised to review and define whether each deviation is a major 
criterion or not. 

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5.2.8. 
Randomisation 
Randomisation will not be stratified. 
 
It will be carried out according to a 1:1 ratio and will be performed in blocks. 
 
Randomisation will be performed using Ennov Clinical by connecting to the website: 
https://nantes-lrsy.hugo-online.fr/EnnovClinical/login. Connection will be made using a login, 
password and study code provided by the data manager of the Clinical Research Unit at La Roche 
sur Yon Hospital. The following information must be provided: 
 
- 
First initial of surname, 
- 
First initial of the first name, 
- 
Month and year of birth, 
- 
Compliance with inclusion and exclusion criteria (yes/no), 
 
 
Randomisation will be carried out after confirmation of the patient's eligibility for inclusion in the 
study. The inclusion number will be assigned automatically during randomisation.  
 
The randomisation list will be drawn up by the statistician at the Research Unit of La Roche sur 
Yon Hospital. An explanatory guide to randomisation will be available online at Ennov Clinical. 
 

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6. SAFETY EVALUATION 
In the context of this Interventional Research with Minimal Risks and Constraints (RIPH Category 
2), adverse events (whether serious or not) do not need to be reported to the sponsor. Notification 
must be made as part of the vigilance system established for the product or practice being 
researched (pharmacovigilance for a drug, material vigilance for a medical device, etc.) in 
accordance with the regulations in force. 
 
Only "new developments" and malfunctions that may interfere with the research must be reported 
to the sponsor without delay after they become known so that corrective measures can be put in 
place. For these malfunctions, the investigator may use the reporting form provided by the 
institution's internal vigilance system, which is anonymised (patient inclusion number only). 
 
A new development is any new information that could lead to a reassessment of the benefits and 
risks of the research or the product being researched, to changes in the use of this product, in the 
conduct of the research, or in the documents relating to the research, or to the suspension, 
interruption or modification of the research protocol or similar research. 
 
The sponsor shall immediately inform the competent authority and the human subjects review 
committee of the new facts and, where applicable, the measures taken, from the day on which 
they become known. 
 

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7. ADMINISTRATIVE AND REGULATORY ASPECTS 
7.1. 
RIGHT OF ACCESS TO SOURCE DATA AND DOCUMENTS 
Each patient's medical data will only be disclosed to the sponsor or any person duly authorised 
by the sponsor and, where applicable, to the competent health authorities, under conditions that 
guarantee confidentiality.  
The sponsor and the supervisory authorities may request direct access to the medical file to verify 
the procedures and/or data of the clinical trial, within the limits authorised by laws and regulations. 
7.2. 
DATA CONFIDENTIALITY 
Persons with direct access shall take all necessary precautions to ensure the confidentiality of 
information relating to the persons involved, in particular with regard to their identity and the results 
obtained. 
These persons, like the investigators themselves, are subject to professional secrecy (under the 
conditions defined by Articles 226-13 and 226-14 of the Penal Code). 
During or at the end of the research, the data collected on the individuals involved and transmitted 
by the participants shall be anonymised. 
Under no circumstances shall the names or addresses of the persons concerned be disclosed.  
Only the first two letters of the subject's surname and the first letter of their first name will be 
recorded, accompanied by a coded number specific to the study indicating the order of inclusion 
of the subjects.  
7.3. 
COMPUTERISED DATA AND SUBMISSION TO THE CNIL 
This study falls within the scope of the "Reference Methodology" (MR-001) in accordance with the 
provisions of Article 54, paragraph 5, of Law No. 78-17 of 6 January 1978, revised in June 2018, 
relating to information technology, files and freedoms. The CHD Vendée de La Roche sur Yon, 
promoter of the study, has signed a commitment to comply with this "Reference Methodology". 

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7.4. 
MONITORING OF THE TRIAL 
Monitoring will be carried out by the Promotion Department of the Research Directorate. A Clinical 
Research Associate (CRA) will visit each site (investigator) regularly to carry out quality control of 
the data reported in the observation notebooks. 
 
The protocol has been classified according to the estimated level of risk for patients participating 
in the research. It will be monitored as follows:  
Risk A: low or negligible foreseeable risk 
 
On-site monitoring visits will be organised after appointment with the investigator. CRAs must be 
able to consult the following at each site: 
- the data collection notebooks for the patients included, 
- the patients' medical and nursing records, 
- the investigator's file. 
7.5. 
INSPECTION/AUDIT 
An inspection or audit may be conducted as part of this study. The sponsor and/or participating 
centres must be able to provide inspectors or auditors with access to the data. 
7.6. 
ETHICAL CONSIDERATIONS 
7.6.1. 
Informed consent  
The investigator (nurse) undertakes to obtain the patient's free, informed and express consent 
after providing them with information about the protocol. 
Minors who are not emancipated will receive information adapted to their level of understanding, 
both from the investigator and from their parents or guardians (who will themselves be informed 
by the investigator).  

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They will be consulted to the extent that their condition allows. Their personal consent to 
participate in the research will be sought. Their refusal or revocation of consent cannot be 
overridden. 
As the patients are minors and this is research involving human subjects with minimal risks and 
constraints in accordance with the decree published on 3 May 2017 establishing the list of such 
research, express informed consent is required from both parents. 
However, in the context of this study, children admitted to paediatric emergency departments are 
rarely accompanied by both parents. Given that randomisation must be carried out before a 
peripheral venous line is inserted, which is necessary for the administration of a prescribed 
treatment that may need to be administered without delay, it will therefore be difficult to obtain the 
written consent of both parents before it is put in place. Under these circumstances, only the 
written consent of the parent present will be obtained after verbal consent has been given by the 
absent parent.  
 
 The investigator will provide a copy of the information sheet and a consent form to the person(s) 
with parental authority. The patient may only be included in the study after having read the 
information sheet, which will be explained to them in accordance with their level of understanding, 
and given their verbal consent if they are old enough to understand, and the person(s) with 
parental authority have given their written consent, after having been given time to consider the 
matter, if necessary.  
 
The investigator must also sign and date the consent form. Two copies of these two documents 
will be provided on paper so that the patient (or those with parental authority) and the investigator 
can each keep a copy. The investigator's original copy will be filed in the investigator's binder. If 
consent is signed in duplicate, the investigator will keep the original and the duplicate will be given 
to the patient. 
The patient's information and verbal agreement to participate in the research must be noted in 
their medical file. Written consent will be given by the person(s) with parental authority.  
For minors who reach the age of majority during their participation, confirmation of their consent 
will be required after appropriate information has been provided.  
Other requests for exemption from the obligation to obtain the signed consent of both 
parents may be submitted to the CPP in the following cases: 
 
- if one of the parents is deceased 
- if the child is recognised by only one parent 

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- if only one parent has been designated as the holder of parental authority by court order 
- in cases of separated or divorced parents 
 
In these cases, only the signed consent of the parent accompanying the child and holding parental 
authority will be obtained. 
 
In the case of separated parents, if the second parent (holder of parental authority) who did not 
sign the initial consent form wishes to withdraw their child from the study, their decision will of 
course be taken into account. 
7.6.2. 
Committee for the Protection of Persons 
The sponsor undertakes to submit the study proposal to a Committee for the Protection of Persons 
(CPP) for prior authorisation. The information provided relates, on the one hand, to the methods 
and nature of the research and, on the other hand, to the safeguards provided for patients 
participating in the trial. 
7.7. 
INFORMATION TO THE COMPETENT AUTHORITIES S 
This protocol will be submitted to the ANSM for information. 
7.8. 
AMENDMENTS TO THE PROTOCOL 
Requests for substantial amendments shall be submitted by the sponsor to the relevant CPP for 
its opinion, to the ANSM for information, and to the relevant Committee for the Protection of 
Persons for authorisation/information, in accordance with the law in force and its implementing 
decrees. 
 
The amended protocol must be updated and dated. 
The patient information and consent forms must be amended if necessary. 

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7.9. 
FINANCING AND INSURANCE 
The sponsor shall finance the study and take out an insurance policy covering the financial 
consequences of its civil liability, in accordance with the regulations. 
7.10. RULES RELATING TO PUBLICATION 
The study will be registered on a freely accessible website (Clinical Trial) before the firstpatient is 
included in the study. 
 
Scientific communications and reports relating to this study shall be produced under the 
responsibility of the study coordinator with the agreement of the principal investigators of the 
participating centres.  
 
The coordinating investigator shall draw up the list of authors.  
 
A doctor affiliated with the CHD Vendée at the time of publication must be listed as the first or 
last author.  
 
Publication rules will follow international recommendations (N Engl J Med, 1997; 336:309-315).  
 
A copy of the publication will be sent to the CHD Vendée, the study sponsor, which will necessarily 
be cited. 
7.11. DISPOSAL OF BIOLOGICAL SAMPLES 
At the end of the research, biological samples resulting from the catheter being sent for culture in 
the event of catheter-related infection will be destroyed. 
 

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7.12. ARCHIVING OF SOURCE DATA 
The investigator must keep all information relating to the study for at least 15 years after the end 
of the study. 
At the end of the study, the investigator will receive a copy of the data for each patient from their 
centre, sent by the sponsor.  
 
No transfer or destruction may be carried out without the Sponsor's consent. At the end of the 15-
year period, the Sponsor will be consulted regarding destruction. All data, documents and reports 
may be subject to audit or inspection. 
 
 

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8. BIBLIOGRAPHICAL REFERENCES 
1. 
Evaluation and improvement of practices, Placement and maintenance of peripheral 
venous catheters, published by SFHH-HAS (Professional Recommendations Department) April 
2007, p.5 
2. 
Johnstone M. The effect of lorazepam on the vasoconstriction of fear. Anaesthesia 1976; 
31:868-72 
 
3. 
Maylon L, Amanda J ULLMAN, Natalie PHILLIPS. Peripheral intravenous catheter 
duration and failure in paediatric acute care: A prospective cohort study, Emergency Medicine 
Australasia, 2014, (26) 602-608. 
 
4. 
Recommendations for clinical practice "Prevention of infections related to peripheral 
venous catheters", published by SFHH – HAS, November 2005. - R 49 
 
5. 
Simona R. A paediatric peripheral intravenous infiltration assessment tool. Infusion 
Nursing Society. 2012 Jul-Aug; 35(4):243-8. 
 
6. 
M Unbeck, U Forberg, B-M Ygge, A Ehrenberg, M Petzold, E Johansson. Peripheral 
venous catheter-related complications are common among paediatric and neonatal patients. 
Foundation Acta Paediatrica. 2015; 104:566-574. 
 
7. 
File on pressure sores/Pressure sores in children - French-language journal on wound 
healing. 2017 July-September; volume 3 
 
8. 
Prevention and Treatment of Pressure Ulcers: A Brief Reference Guide. National Pressure 
Ulcer Advisory Panel, European Pressure Advisory Panel and Pan Pacific Pressure Injury 
Alliance. 2014 
 
9. 
Martha A.Q. Curley, RN, PhD, Natalie R. Hasbani, MPH et al. Predicting Pressure Injury 
Risk in Paediatric Patients: The Braden QD Scale. The Journal of Paediatrics, January 2018, 
volume 192, 189-195. 
 
10. 
John S. Murray, Catherine Noonan, Sandy Quigley et al. Medical Device-Related Hospital-
Acquired Pressure Ulcers in Children: An Integrative Review, Journal of Paediatric Nursing, 2013; 
28, 585-595. 

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11. 
www.pediadol.org website, insertion of a peripheral venous catheter, excerpt from the 
booklet La douleur de l’enfant : stratégies soignantes de prévention et de prise en charge (Pain 
in children: care strategies for prevention and management), April 2010. 
 
12. 
E. Thueux. Pressure ulcer prevention in paediatric intensive care. Soins Pédiatrie-
Puériculture 2014 July-August; 279, 24-28. 
 
13. 
SF2H (French Society for Hospital Hygiene) recommendations, Prevention of infections 
related to peripheral vascular and subcutaneous catheters, volume XXVII - No. 2 - May 2019. 
 
14. Official dermatology website, Dermato-info.fr, article "The skin of the full-term newborn, 
Characteristics of the skin function of the newborn," 2019. 
 
15.    Jesada EC, Warren JI, Goodman D, IliutaRW, Thurkauf G, McLaughlin MK, Johnson JE, 
Strassner L. Staging and Defining Characteristics of Pressure Ulcers Using Photographs by Staff 
Nurses in Acute Care Settings, Journal of WoundOstomy and Continence Nursing. Mar-Apr2013, 
40(2):150–156. 
 
 

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LIST OF APPENDICES 
 
 
 
 
Appendix 1) Catheter insertion protocol with compress 
 
Appendix 2) Catheter placement protocol without compress 
 
Appendix 3) Data collected