HEAL Study: Healing Results, Efficacy and Acceptability of a New Contact Layer (HEAL)
Primary Purpose
Wound
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
URGO AWC_019 dressing (AWC=Advanced Wound Care)
Sponsored by
About this trial
This is an interventional treatment trial for Wound
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
URGO AWC_019 dressing (AWC=Advanced Wound Care)
Arm Description
URGO AWC_019 dressing (AWC=Advanced Wound Care)
Outcomes
Primary Outcome Measures
Relative evolution of the wound surface (in %) at week 4
Relative evolution of the wound surface (in %) at week 4
Secondary Outcome Measures
- 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)
- Wound dressing safety (occurrence of adverse events)
- Wound dressing safety (occurrence of adverse events)
- Percentage of healed wounds (healing rate) after 4 weeks of treatment
- Percentage of healed wounds (healing rate) after 4 weeks of treatment
- Wound healing time (in days)
- Wound healing time (in days)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03640871
Brief Title
HEAL Study: Healing Results, Efficacy and Acceptability of a New Contact Layer
Acronym
HEAL
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2018 (Anticipated)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
November 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoires URGO
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
URGO AWC_019 dressing (AWC=Advanced Wound Care)
Arm Type
Experimental
Arm Description
URGO AWC_019 dressing (AWC=Advanced Wound Care)
Intervention Type
Device
Intervention Name(s)
URGO AWC_019 dressing (AWC=Advanced Wound Care)
Intervention Description
URGO AWC_019 dressing 10x10 cm (AWC=Advanced Wound Care)
Primary Outcome Measure Information:
Title
Relative evolution of the wound surface (in %) at week 4
Description
Relative evolution of the wound surface (in %) at week 4
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
- Pain on wound URGO AWC_019 dressing removal (measured thanks to Analogical Visual Scale: no pain = 0 mm and unbearable pain = 100 mm)
Description
- 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
Title
- Wound dressing safety (occurrence of adverse events)
Description
- Wound dressing safety (occurrence of adverse events)
Time Frame
4 weeks
Title
- Percentage of healed wounds (healing rate) after 4 weeks of treatment
Description
- Percentage of healed wounds (healing rate) after 4 weeks of treatment
Time Frame
4 weeks
Title
- Wound healing time (in days)
Description
- Wound healing time (in days)
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clémence Ms Tumba, PharmD
Phone
++33380447409
Email
c.tumba@fr.urgo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
HEAL Study: Healing Results, Efficacy and Acceptability of a New Contact Layer
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