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

NCT03640871 | Unknown

• 1 other identifier: F-18-06-AWC019
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Conditions

Wound

Outcome Measures

Primary Outcomes (1)

• Relative evolution of the wound surface (in %) at week 4

  Relative evolution of the wound surface (in %) at week 4

  4 weeks

Secondary Outcomes (4)

• - 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)

  4 weeks

• - Percentage of healed wounds (healing rate) after 4 weeks of treatment

  4 weeks

• - Wound healing time (in days)

  4 weeks

Study Arms (1)

URGO AWC_019 dressing (AWC=Advanced Wound Care)

EXPERIMENTAL

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

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

Interventions

URGO AWC_019 dressing (AWC=Advanced Wound Care) DEVICE

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

URGO AWC_019 dressing (AWC=Advanced Wound Care)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Laboratoires URGO: lead

MeSH Terms

Conditions

Wounds and Injuries

Central Study Contacts

Clémence Ms Tumba, PharmD

CONTACT

++33380447409; c.tumba@fr.urgo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 21, 2018
• Study Start: October 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: August 22, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share