Comparison of Efficacy on Healing, and Safety of Two Dressings Urgotul and TulleGras MS on Surgical Acute Wounds.

Study Overview
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Brief Summary
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Evaluation of non-inferiority on healing rates of two dressings Urgotul and TulleGras MS in the treatment of surgical acute wounds.

Official Title
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Multicentre, Randomized, Parallel Group, Non-inferiority, Open-label Study Aiming at Comparing the Healing Rates (With Blinded Assessment Based on Photographs) of TULLEGRAS M.S.® With URGOTUL® in the Treatment of Surgical Acute Wounds.

Conditions
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Surgical Acute Wounds

Intervention / Treatment
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* Device: Urgotul: Low-adherent dressing
* Device: TulleGras M.S.: Vaseline gauze


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TulleGras M.S.<br>Sterile dressing that consists of viscose tissue coated with mineral vaseline | Device: TulleGras M.S.: Vaseline gauze<br> <br> |
| Active Comparator: Urgotul<br>Sterile, hydrocolloid dressing, that consists of a polyester fabric coated with hydrocolloid particles and vaseline | Device: Urgotul: Low-adherent dressing<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Complete Healing (100% of Epithelialization). | Using photographs,independent assessor blinded assessment. | Day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-inferiority, randomized, TulleGras, Urgotul, healing, surgical acute wounds, pain