Clinical trial NCT03640871: HEAL Study: Healing Results, Efficacy and Acceptability of a New Contact Layer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wound
Lead sponsor: Laboratoires URGO
Sponsor class: INDUSTRY
First posted: 2018-08-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Relative evolution of the wound surface (in %) at week 4
timeFrame: 4 weeks
Secondary outcomes:
measure: - Pain on wound URGO AWC_019 dressing removal (measured thanks to Analogical Visual Scale: no pain = 0 mm and unbearable pain = 100 mm)
timeFrame: 4 weeks
measure: - Wound dressing safety (occurrence of adverse events)
timeFrame: 4 weeks
measure: - Percentage of healed wounds (healing rate) after 4 weeks of treatment
timeFrame: 4 weeks
measure: - Wound healing time (in days)
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References: