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

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ClinicalTrials.gov Identifier: NCT03640871
Recruitment Status : Unknown
Verified July 2018 by Laboratoires URGO.
Recruitment status was:  Not yet recruiting
First Posted : August 21, 2018
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Laboratoires URGO

Study Description
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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

Condition or disease Intervention/treatment Phase
Wound Device: URGO AWC_019 dressing (AWC=Advanced Wound Care) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: URGO AWC_019 dressing (AWC=Advanced Wound Care)
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)


Outcome Measures
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Primary Outcome Measures :
  1. Relative evolution of the wound surface (in %) at week 4 [ Time Frame: 4 weeks ]
    Relative evolution of the wound surface (in %) at week 4


Secondary Outcome Measures :
  1. - Pain on wound URGO AWC_019 dressing removal (measured thanks to Analogical Visual Scale: no pain = 0 mm and unbearable pain = 100 mm) [ Time Frame: 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)

  2. - Wound dressing safety (occurrence of adverse events) [ Time Frame: 4 weeks ]
    - Wound dressing safety (occurrence of adverse events)

  3. - Percentage of healed wounds (healing rate) after 4 weeks of treatment [ Time Frame: 4 weeks ]
    - Percentage of healed wounds (healing rate) after 4 weeks of treatment

  4. - Wound healing time (in days) [ Time Frame: 4 weeks ]
    - Wound healing time (in days)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03640871


Contacts
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Contact: Clémence Ms Tumba, PharmD ++33380447409 c.tumba@fr.urgo.com

Sponsors and Collaborators
Laboratoires URGO
More Information
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Responsible Party: Laboratoires URGO
ClinicalTrials.gov Identifier: NCT03640871    
Other Study ID Numbers: F-18-06-AWC019
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wounds and Injuries