Comparison of Efficacy on Healing, and Safety of Two Dressings Urgotul and TulleGras MS on Surgical Acute Wounds.
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.
2 other identifiers
interventional
208
1 country
33
Brief Summary
Evaluation of non-inferiority on healing rates of two dressings Urgotul and TulleGras MS in the treatment of surgical acute wounds.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2014
Typical duration for not_applicable
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 19, 2014
CompletedFirst Posted
Study publicly available on registry
December 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedResults Posted
Study results publicly available
March 13, 2019
CompletedMarch 21, 2022
March 1, 2017
1.9 years
December 19, 2014
April 11, 2017
March 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Patients With Complete Healing (100% of Epithelialization).
Using photographs,independent assessor blinded assessment.
Day 21
Study Arms (2)
TulleGras M.S.
ACTIVE COMPARATORSterile dressing that consists of viscose tissue coated with mineral vaseline
Urgotul
ACTIVE COMPARATORSterile, hydrocolloid dressing, that consists of a polyester fabric coated with hydrocolloid particles and vaseline
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- Pregnancy or breastfeeding or of childbearing potential and saying not to use contraception.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mylan Inc.lead
- Foveacollaborator
Study Sites (33)
Research facility ID ORG-001264
Ajaccio, 20303, France
Research facility ID ORG-001263
Angoulême, 16959, France
Research facility ORG-001090
Athis-Mons, 91200, France
Research facility ORG-001101
Aubervilliers, 93300, France
Research facility ID ORG-001099
Carpentras, 84200, France
Research facility ORG-001099
Carpentras, 84200, France
Research facility ORG-001107
Cornebarrieu, 31700, France
Research facility ID ORG-001223
La Rochelle, 17000, France
Research facility ORG-001096
Levallois-Perret, 92300, France
Research facility ID ORG-001276
Lille, 59037, France
Research facility ORG-001102
Lille, 59037, France
Research facility ORG-001360
Lyon, 69003, France
Research facility ORG-001132
Mantes-la-Jolie, 78200, France
Research facility ID ORG-001133
Montpellier, 34295, France
Research facility ORG-001133
Montpellier, 34295, France
Research facility ID ORG-001220
Montreuil, 93105, France
Research facility ID ORG-001189
Nice, 6002, France
Research facility ID ORG-001190
Ollioules, 89190, France
Research facility ID ORG-001088
Paris, 75008, France
Research facility ID ORG-001105
Paris, 75008, France
Research facility ORG-001105
Paris, 75008, France
Research facility ID ORG-001134
Paris, 75014, France
Research facility ID ORG-001265
Paris, 75014, France
Research facility ORG-001088
Paris, 75018, France
Research facility ID ORG-001221
Paris, 75877, France
Research facility ORG-001166
Pierre-Bénite, 69495, France
Research facility ID ORG-001278
Reims, 51090, France
Research facility ORG-001137
Roubaix, 59100, France
Research facility ORG-001136
Rouen, 76000, France
Research facility ORG-001089
Saint-Nazaire, 44600, France
Research facility ID ORG-001222
Sarreguemines, 57200, France
Research facility ORG-001097
Sarreguemines, 57200, France
Research facility ORG-001093
Toulon, 83100, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Rafik NAMANE MD.
- Organization
- Mylan Medical SAS
Study Officials
- STUDY DIRECTOR
Roger LESAUNIER, MD
Mylan
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2014
First Posted
December 23, 2014
Study Start
December 1, 2014
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
March 21, 2022
Results First Posted
March 13, 2019
Record last verified: 2017-03