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

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

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

Study Overview

• Status: Unknown
• Conditions: Wound
• Intervention / Treatment: Device: URGO AWC_019 dressing (AWC=Advanced Wound Care)

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clémence Ms Tumba, PharmD; Phone Number: ++33380447409; Email: c.tumba@fr.urgo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: URGO AWC_019 dressing (AWC=Advanced Wound Care)	Device: URGO AWC_019 dressing (AWC=Advanced Wound Care); URGO AWC_019 dressing 10x10 cm (AWC=Advanced Wound Care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative evolution of the wound surface (in %) at week 4	Relative evolution of the wound surface (in %) at week 4	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
- Pain on wound URGO AWC_019 dressing removal (measured thanks to Analogical Visual Scale: no pain = 0 mm and unbearable pain = 100 mm)	- 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
- Wound dressing safety (occurrence of adverse events)	- Wound dressing safety (occurrence of adverse events)	4 weeks
- Percentage of healed wounds (healing rate) after 4 weeks of treatment	- Percentage of healed wounds (healing rate) after 4 weeks of treatment	4 weeks
- Wound healing time (in days)	- Wound healing time (in days)	4 weeks

Collaborators and Investigators

• Sponsor: Laboratoires URGO

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2018
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): November 1, 2019

Study Registration Dates

• First Submitted: August 3, 2018
• First Submitted That Met QC Criteria: August 20, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): August 22, 2018
• Last Update Submitted That Met QC Criteria: August 21, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: F-18-06-AWC019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No