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

March 17, 2022 updated by: Mylan Inc.

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Ajaccio, France, 20303
        • Research facility ID ORG-001264
      • Angoulême, France, 16959
        • Research facility ID ORG-001263
      • Athis-Mons, France, 91200
        • Research facility ORG-001090
      • Aubervilliers, France, 93300
        • Research facility ORG-001101
      • Carpentras, France, 84200
        • Research facility ID ORG-001099
      • Carpentras, France, 84200
        • Research facility ORG-001099
      • Cornebarrieu, France, 31700
        • Research facility ORG-001107
      • La Rochelle, France, 17000
        • Research facility ID ORG-001223
      • Levallois Perret, France, 92300
        • Research facility ORG-001096
      • Levallois-perret, France, 92300
        • Research facility ORG-001096
      • Lille, France, 59037
        • Research facility ID ORG-001276
      • Lille, France, 59037
        • Research facility ORG-001102
      • Lyon, France, 69003
        • Research facility ORG-001360
      • Mantes La Jolie, France, 78200
        • Research facility ORG-001132
      • Montpellier, France, 34295
        • Research facility ID ORG-001133
      • Montpellier cedex 5, France, 34295
        • Research facility ORG-001133
      • Montreuil-sous-Bois Cedex, France, 93105
        • Research facility ID ORG-001220
      • Nice, France, 6002
        • Research facility ID ORG-001189
      • Ollioules, France, 89190
        • Research facility ID ORG-001190
      • Paris, France, 75008
        • Research facility ID ORG-001088
      • Paris, France, 75008
        • Research facility ID ORG-001105
      • Paris, France, 75008
        • Research facility ORG-001105
      • Paris, France, 75014
        • Research facility ID ORG-001134
      • Paris, France, 75014
        • Research facility ID ORG-001265
      • Paris, France, 75018
        • Research facility ORG-001088
      • Paris Cedex 18, France, 75877
        • Research facility ID ORG-001221
      • Pierre Benite, France, 69495
        • Research facility ORG-001166
      • Reims, France, 51090
        • Research facility ID ORG-001278
      • Roubaix, France, 59100
        • Research facility ORG-001137
      • Rouen, France, 76000
        • Research facility ORG-001136
      • Saint Nazaire, France, 44600
        • Research facility ORG-001089
      • Sarreguemines, France, 57200
        • Research facility ID ORG-001222
      • Sarreguemines, France, 57200
        • Research facility ORG-001097
      • Toulon, France, 83100
        • Research facility ORG-001093

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mylan Inc.

Collaborators

Fovea

Investigators

  • Study Director: Roger LESAUNIER, MD, Mylan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

December 19, 2014

First Submitted That Met QC Criteria

December 19, 2014

First Posted (Estimate)

December 23, 2014

Study Record Updates

Last Update Posted (Actual)

March 21, 2022

Last Update Submitted That Met QC Criteria

March 17, 2022

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LINE4002
  • 2014-A00914-43 (Other Identifier: ANSM (French Health Agency) Registry number for biomedical research)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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