Comparison of Efficacy on Healing, and Safety of Two Dressings Urgotul and TulleGras MS on Surgical Acute Wounds.
Not Applicable
Completed
- Conditions
- Surgical Acute Wounds
- Registration Number
- NCT02322710
- Lead Sponsor
- Mylan Inc.
- Brief Summary
Evaluation of non-inferiority on healing rates of two dressings Urgotul and TulleGras MS in the treatment of surgical acute wounds.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 208
Inclusion Criteria
- Male or female subject.
- Aged 18 to 75 years
- With a planned surgery:
- Of abdominal location
- Leading to an acute wound of a maximum total length ≤ 18 cm (corresponding to 2 investigational products)
- Absence of clinical sign suggestive of worsened wound (assessed only at the randomization visit)
- Followed-up in surgery department
- Written and signed informed consent obtained
- Affiliated to the French Social Security system or equivalent.
Exclusion Criteria
- Underlying pathology that may interfere with wound healing in the opinion of the Investigator (human immunodeficiency virus [HIV], cancer, immunodeficiency disease, generalized infection, systemic disease ...). The presence of low-risk prostate cancer according to the Amico classification (1) (PSA<10 ng/mL and Gleason's score < 6 and clinical grade T1c ou T2a) or a grade T1 (a or b) N0M0 renal cancer which requires surgery without adjuvant therapy (radiotherapy, chemotherapy, hormonal therapy...), in a patient whose general condition is preserved without significant comorbidity or signs of malnutrition are not considered as a non- inclusion criteria
- Inadequately controlled diabetes (Glycosylated hemoglobin > 8%)
- Hypo or hyperthyroidism
- Intake of a systemic treatment with glucocorticoids or immunosuppressives
- Known allergy to one of study dressings components
- Participation in a clinical trial in the month prior to his/her inclusion in the study
- Pregnancy or breastfeeding or of childbearing potential and saying not to use contraception.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percentage of Patients With Complete Healing (100% of Epithelialization). Day 21 Using photographs,independent assessor blinded assessment.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (33)
Research facility ID ORG-001264
🇫🇷Ajaccio, France
Research facility ID ORG-001263
🇫🇷Angoulême, France
Research facility ORG-001090
🇫🇷Athis-Mons, France
Research facility ORG-001101
🇫🇷Aubervilliers, France
Research facility ID ORG-001099
🇫🇷Carpentras, France
Research facility ORG-001099
🇫🇷Carpentras, France
Research facility ORG-001107
🇫🇷Cornebarrieu, France
Research facility ID ORG-001223
🇫🇷La Rochelle, France
Research facility ORG-001096
🇫🇷Levallois-perret, France
Research facility ID ORG-001276
🇫🇷Lille, France
Scroll for more (23 remaining)Research facility ID ORG-001264🇫🇷Ajaccio, France