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

Wound Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03640871
• Other study ID #: F-18-06-AWC019
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2018
• Est. completion date: November 2019

Study information

• Verified date: July 2018
• Source: Laboratoires URGO
• Contact: Clémence Ms Tumba, PharmD
• Phone: ++33380447409
• Email: c.tumba[@]fr.urgo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Wound

Intervention

Device:
• URGO AWC_019 dressing (AWC=Advanced Wound Care)
URGO AWC_019 dressing 10x10 cm (AWC=Advanced Wound Care)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires URGO

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative evolution of the wound surface (in %) at week 4	Relative evolution of the wound surface (in %) at week 4	4 weeks
Secondary	- 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
Secondary	- Wound dressing safety (occurrence of adverse events)	- Wound dressing safety (occurrence of adverse events)	4 weeks
Secondary	- Percentage of healed wounds (healing rate) after 4 weeks of treatment	- Percentage of healed wounds (healing rate) after 4 weeks of treatment	4 weeks
Secondary	- Wound healing time (in days)	- Wound healing time (in days)	4 weeks