Surgical Acute Wounds Clinical Trial
Official title:
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.
| Verified date | March 2017 |
| Source | Viatris Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Evaluation of non-inferiority on healing rates of two dressings Urgotul and TulleGras MS in the treatment of surgical acute wounds.
| Status | Completed |
| Enrollment | 208 |
| Est. completion date | November 2016 |
| Est. primary completion date | November 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | 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 ORG-001096 | Levallois-perret | |
| France | Research facility ID ORG-001276 | Lille | |
| France | Research facility ORG-001102 | Lille | |
| France | Research facility ORG-001360 | Lyon | |
| France | Research facility ORG-001132 | Mantes La Jolie | |
| France | Research facility ID ORG-001133 | Montpellier | |
| France | Research facility ORG-001133 | Montpellier cedex 5 | |
| France | Research facility ID ORG-001220 | Montreuil-sous-Bois Cedex | |
| France | Research facility ID ORG-001189 | Nice | |
| France | Research facility ID ORG-001190 | Ollioules | |
| France | Research facility ID ORG-001088 | Paris | |
| France | Research facility ID ORG-001105 | Paris | |
| France | Research facility ID ORG-001134 | Paris | |
| France | Research facility ID ORG-001265 | Paris | |
| France | Research facility ORG-001088 | Paris | |
| France | Research facility ORG-001105 | Paris | |
| France | Research facility ID ORG-001221 | Paris Cedex 18 | |
| France | Research facility ORG-001166 | Pierre Benite | |
| France | Research facility ID ORG-001278 | Reims | |
| France | Research facility ORG-001137 | Roubaix | |
| France | Research facility ORG-001136 | Rouen | |
| France | Research facility ORG-001089 | Saint Nazaire | |
| France | Research facility ID ORG-001222 | Sarreguemines | |
| France | Research facility ORG-001097 | Sarreguemines | |
| France | Research facility ORG-001093 | Toulon |
| Lead Sponsor | Collaborator |
|---|---|
| Mylan Inc. | Fovea |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Patients With Complete Healing (100% of Epithelialization). | Using photographs,independent assessor blinded assessment. | Day 21 |