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

NCT ID: NCT03640871

Last Updated: 2018-08-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-31
• Study Completion Date: 2019-11-30

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

Conditions

Wound

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

URGO AWC_019 dressing (AWC=Advanced Wound Care)

URGO AWC\_019 dressing (AWC=Advanced Wound Care)

Group Type: EXPERIMENTAL

URGO AWC_019 dressing (AWC=Advanced Wound Care)

Intervention Type: DEVICE

URGO AWC\_019 dressing 10x10 cm (AWC=Advanced Wound Care)

Interventions

URGO AWC_019 dressing (AWC=Advanced Wound Care)

URGO AWC\_019 dressing 10x10 cm (AWC=Advanced Wound Care)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratoires URGO

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Clémence Ms Tumba, PharmD

Role: CONTACT

c.tumba@fr.urgo.com

++33380447409

Other Identifiers

F-18-06-AWC019

Identifier Type: -

Identifier Source: org_study_id