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

Not Applicable

• Conditions: Wound
• Interventions: Device: URGO AWC_019 dressing (AWC=Advanced Wound Care)

• Registration Number: NCT03640871
• Lead Sponsor: Laboratoires URGO

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

Study Timeline

• Status Verified: 2018-07
• Study First Submitted: 2018-08-03
• Study First Submitted QC: 2018-08-20
• Study First Posted: 2018-08-21
• Last Update Submitted: 2018-08-21
• Last Update Posted: 2018-08-22
• Study Start: 2018-10
• Primary Completion: 2019-11
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
URGO AWC_019 dressing (AWC=Advanced Wound Care)	URGO AWC_019 dressing (AWC=Advanced Wound Care)	URGO AWC_019 dressing (AWC=Advanced Wound Care)

Primary Outcome Measures

Name	Time	Method
Relative evolution of the wound surface (in %) at week 4	4 weeks	Relative evolution of the wound surface (in %) at week 4

Secondary Outcome Measures

Name	Time	Method
- Wound healing time (in days)	4 weeks	- Wound healing time (in days)
- Percentage of healed wounds (healing rate) after 4 weeks of treatment	4 weeks	- Percentage of healed wounds (healing rate) after 4 weeks of treatment
- 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)