HEAL Study: Healing Results, Efficacy and Acceptability of a New Contact Layer

Study Overview
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Brief Summary
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Assessment of efficacy, tolerance and acceptability for the wound dressing URGO AWC_019 in the treatment of acute wounds, chronic wounds and epidermolysis bullosa skin lesions

Detailed Description
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Non-comparative clinical study, conducted in France, to evaluate efficacy, tolerance and acceptability for the wound dressing URGO AWC_019 in the treatment of acute wounds, chronic wounds and epidermolysis bullosa skin lesions

Official Title
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Assessment of Efficacy, Tolerance and Acceptability for the Wound Dressing URGO AWC_019 in the Local Treatment of Acute Wounds, Chronic Wounds and Epidermolysis Bullosa Skin Lesions

Conditions
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Wound

Intervention / Treatment
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* Device: URGO AWC_019 dressing (AWC=Advanced Wound Care)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A. Related to every wounds types: Patient over 18 years old who has provided his/her written informed consent Patient affiliated to the French Social insurance Patient who can be monitored by the same investigation team throughout the whole duration of the study, Acute wound (postoperative non-cavitary and non-sutured wound, superficial, middle or deep second degree burn, dermabrasion) or chronic wound (venous or mixed leg ulcer, pressure ulcer) or epidermolysis bullosa skin lesion Use of a contact layer as a primary dressing justified by the wound B. Related to leg ulcer: Venous leg ulcer or mixed leg ulcer, i.e. with an Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3, (0.7≤ABPI≤ 1.3) Patient who agrees to wear an effective venous compression system every day, associated with the trial dressing C. Related to pressure ulcer: Stage 2, 3 according to the EPUAP (European Pressure Ulcer Advisory Panel) classification system Wound on the pelvis (trochanter, ischio or sacrum) or on the heel Exclusion Criteria: Patient under authorship or guardianship Woman of child-bearing potential who has no effective contraception method Pregnant or breastfeeding woman Patient taking part in another clinical trial Patient with a known allergy to carboxymethylcellulose (hydrocolloid), Patient with a severe illness that might lead to the premature discontinuation of the trial before the 4 weeks of treatment Wound requiring surgical treatment or for which surgery is scheduled during the 4 weeks after inclusion Patient with an evolving neoplasia condition, treated by radiotherapy, chemotherapy or hormone therapy Malignant wound Patient with a systemic infection not controlled by suitable antibiotic treatment, Wound which is clinically infected

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: URGO AWC_019 dressing (AWC=Advanced Wound Care)<br>URGO AWC_019 dressing (AWC=Advanced Wound Care) | Device: URGO AWC_019 dressing (AWC=Advanced Wound Care)<br>* URGO AWC_019 dressing 10x10 cm (AWC=Advanced Wound Care)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative evolution of the wound surface (in %) at week 4 | Relative evolution of the wound surface (in %) at week 4 | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Pain on wound URGO AWC_019 dressing removal (measured thanks to Analogical Visual Scale: no pain = 0 mm and unbearable pain = 100 mm) | - Pain on wound URGO AWC_019 dressing removal (measured thanks to Analogical Visual Scale: no pain = 0 mm and unbearable pain = 100 mm) | 4 weeks | 
| - Wound dressing safety (occurrence of adverse events) | - Wound dressing safety (occurrence of adverse events) | 4 weeks | 
| - Percentage of healed wounds (healing rate) after 4 weeks of treatment | - Percentage of healed wounds (healing rate) after 4 weeks of treatment | 4 weeks | 
| - Wound healing time (in days) | - Wound healing time (in days) | 4 weeks |