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

URGO Group

Status

Unknown

Conditions

Wound

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT03640871

F-18-06-AWC019

Details and patient eligibility

About

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

Full 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

Enrollment

80 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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