Wound
Conditions
Brief summary
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
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
Interventions
DEVICEURGO AWC_019 dressing (AWC=Advanced Wound Care)
URGO AWC\_019 dressing 10x10 cm (AWC=Advanced Wound Care)
Sponsors
Laboratoires URGO
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative evolution of the wound surface (in %) at week 4 | 4 weeks | Relative evolution of the wound surface (in %) at week 4 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| - 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 | \- Pain on wound URGO AWC\_019 dressing removal (measured thanks to Analogical Visual Scale: no pain = 0 mm and unbearable pain = 100 mm) |
| - Wound dressing safety (occurrence of adverse events) | 4 weeks | \- Wound dressing safety (occurrence of adverse events) |
| - Percentage of healed wounds (healing rate) after 4 weeks of treatment | 4 weeks | \- Percentage of healed wounds (healing rate) after 4 weeks of treatment |
| - Wound healing time (in days) | 4 weeks | \- Wound healing time (in days) |
Contacts
Primary ContactClémence Ms Tumba, PharmD
Outcome results
None listed