Clinical trial NCT02322710: Comparison of Efficacy on Healing, and Safety of Two Dressings Urgotul and TulleGras MS on Surgical Acute Wounds.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Acute Wounds
Keywords: non-inferiority
randomized
TulleGras
Urgotul
healing
surgical acute wounds
pain
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: Fovea
First posted: 2014-12-23
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Patients With Complete Healing (100% of Epithelialization).
timeFrame: Day 21
Secondary outcomes:
Other outcomes:
Locations:
city: Ajaccio
country: France
facility: Research facility ID ORG-001264
city: Angoulême
country: France
facility: Research facility ID ORG-001263
city: Athis-Mons
country: France
facility: Research facility ORG-001090
city: Aubervilliers
country: France
facility: Research facility ORG-001101
city: Carpentras
country: France
facility: Research facility ID ORG-001099
city: Carpentras
country: France
facility: Research facility ORG-001099
city: Cornebarrieu
country: France
facility: Research facility ORG-001107
city: La Rochelle
country: France
facility: Research facility ID ORG-001223
city: Levallois Perret
country: France
facility: Research facility ORG-001096
city: Levallois-perret
country: France
facility: Research facility ORG-001096
city: Lille
country: France
facility: Research facility ID ORG-001276
city: Lille
country: France
facility: Research facility ORG-001102
city: Lyon
country: France
facility: Research facility ORG-001360
city: Mantes La Jolie
country: France
facility: Research facility ORG-001132
city: Montpellier cedex 5
country: France
facility: Research facility ORG-001133
city: Montpellier
country: France
facility: Research facility ID ORG-001133
city: Montreuil-sous-Bois Cedex
country: France
facility: Research facility ID ORG-001220
city: Nice
country: France
facility: Research facility ID ORG-001189
city: Ollioules
country: France
facility: Research facility ID ORG-001190
city: Paris Cedex 18
country: France
facility: Research facility ID ORG-001221
city: Paris
country: France
facility: Research facility ID ORG-001088
city: Paris
country: France
facility: Research facility ID ORG-001105
city: Paris
country: France
facility: Research facility ORG-001105
city: Paris
country: France
facility: Research facility ID ORG-001134
city: Paris
country: France
facility: Research facility ID ORG-001265
city: Paris
country: France
facility: Research facility ORG-001088
city: Pierre Benite
country: France
facility: Research facility ORG-001166
city: Reims
country: France
facility: Research facility ID ORG-001278
city: Roubaix
country: France
facility: Research facility ORG-001137
city: Rouen
country: France
facility: Research facility ORG-001136
city: Saint Nazaire
country: France
facility: Research facility ORG-001089
city: Sarreguemines
country: France
facility: Research facility ID ORG-001222
city: Sarreguemines
country: France
facility: Research facility ORG-001097
city: Toulon
country: France
facility: Research facility ORG-001093
Study officials:
affiliation: Mylan
name: Roger LESAUNIER, MD
role: STUDY_DIRECTOR
References: