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

Primary Purpose

Surgical Acute Wounds

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Urgotul: Low-adherent dressing
TulleGras M.S.: Vaseline gauze
Sponsored by
Mylan Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Acute Wounds focused on measuring non-inferiority, randomized, TulleGras, Urgotul, healing, surgical acute wounds, pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Research facility ID ORG-001264
  • Research facility ID ORG-001263
  • Research facility ORG-001090
  • Research facility ORG-001101
  • Research facility ID ORG-001099
  • Research facility ORG-001099
  • Research facility ORG-001107
  • Research facility ID ORG-001223
  • Research facility ORG-001096
  • Research facility ORG-001096
  • Research facility ID ORG-001276
  • Research facility ORG-001102
  • Research facility ORG-001360
  • Research facility ORG-001132
  • Research facility ORG-001133
  • Research facility ID ORG-001133
  • Research facility ID ORG-001220
  • Research facility ID ORG-001189
  • Research facility ID ORG-001190
  • Research facility ID ORG-001221
  • Research facility ID ORG-001088
  • Research facility ID ORG-001105
  • Research facility ORG-001105
  • Research facility ID ORG-001134
  • Research facility ID ORG-001265
  • Research facility ORG-001088
  • Research facility ORG-001166
  • Research facility ID ORG-001278
  • Research facility ORG-001137
  • Research facility ORG-001136
  • Research facility ORG-001089
  • Research facility ID ORG-001222
  • Research facility ORG-001097
  • Research facility ORG-001093

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TulleGras M.S.

Urgotul

Arm Description

Sterile dressing that consists of viscose tissue coated with mineral vaseline

Sterile, hydrocolloid dressing, that consists of a polyester fabric coated with hydrocolloid particles and vaseline

Outcomes

Primary Outcome Measures

Percentage of Patients With Complete Healing (100% of Epithelialization).
Using photographs,independent assessor blinded assessment.

Secondary Outcome Measures

Full Information

First Posted
December 19, 2014
Last Updated
March 17, 2022
Sponsor
Mylan Inc.
Collaborators
Fovea
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1. Study Identification

Unique Protocol Identification Number
NCT02322710
Brief Title
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mylan Inc.
Collaborators
Fovea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Acute Wounds
Keywords
non-inferiority, randomized, TulleGras, Urgotul, healing, surgical acute wounds, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TulleGras M.S.
Arm Type
Active Comparator
Arm Description
Sterile dressing that consists of viscose tissue coated with mineral vaseline
Arm Title
Urgotul
Arm Type
Active Comparator
Arm Description
Sterile, hydrocolloid dressing, that consists of a polyester fabric coated with hydrocolloid particles and vaseline
Intervention Type
Device
Intervention Name(s)
Urgotul: Low-adherent dressing
Intervention Type
Device
Intervention Name(s)
TulleGras M.S.: Vaseline gauze
Primary Outcome Measure Information:
Title
Percentage of Patients With Complete Healing (100% of Epithelialization).
Description
Using photographs,independent assessor blinded assessment.
Time Frame
Day 21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger LESAUNIER, MD
Organizational Affiliation
Mylan
Official's Role
Study Director
Facility Information:
Facility Name
Research facility ID ORG-001264
City
Ajaccio
ZIP/Postal Code
20303
Country
France
Facility Name
Research facility ID ORG-001263
City
Angoulême
ZIP/Postal Code
16959
Country
France
Facility Name
Research facility ORG-001090
City
Athis-Mons
ZIP/Postal Code
91200
Country
France
Facility Name
Research facility ORG-001101
City
Aubervilliers
ZIP/Postal Code
93300
Country
France
Facility Name
Research facility ID ORG-001099
City
Carpentras
ZIP/Postal Code
84200
Country
France
Facility Name
Research facility ORG-001099
City
Carpentras
ZIP/Postal Code
84200
Country
France
Facility Name
Research facility ORG-001107
City
Cornebarrieu
ZIP/Postal Code
31700
Country
France
Facility Name
Research facility ID ORG-001223
City
La Rochelle
ZIP/Postal Code
17000
Country
France
Facility Name
Research facility ORG-001096
City
Levallois Perret
ZIP/Postal Code
92300
Country
France
Facility Name
Research facility ORG-001096
City
Levallois-perret
ZIP/Postal Code
92300
Country
France
Facility Name
Research facility ID ORG-001276
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Research facility ORG-001102
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Research facility ORG-001360
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Research facility ORG-001132
City
Mantes La Jolie
ZIP/Postal Code
78200
Country
France
Facility Name
Research facility ORG-001133
City
Montpellier cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Research facility ID ORG-001133
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Research facility ID ORG-001220
City
Montreuil-sous-Bois Cedex
ZIP/Postal Code
93105
Country
France
Facility Name
Research facility ID ORG-001189
City
Nice
ZIP/Postal Code
6002
Country
France
Facility Name
Research facility ID ORG-001190
City
Ollioules
ZIP/Postal Code
89190
Country
France
Facility Name
Research facility ID ORG-001221
City
Paris Cedex 18
ZIP/Postal Code
75877
Country
France
Facility Name
Research facility ID ORG-001088
City
Paris
ZIP/Postal Code
75008
Country
France
Facility Name
Research facility ID ORG-001105
City
Paris
ZIP/Postal Code
75008
Country
France
Facility Name
Research facility ORG-001105
City
Paris
ZIP/Postal Code
75008
Country
France
Facility Name
Research facility ID ORG-001134
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Research facility ID ORG-001265
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Research facility ORG-001088
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Research facility ORG-001166
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Research facility ID ORG-001278
City
Reims
ZIP/Postal Code
51090
Country
France
Facility Name
Research facility ORG-001137
City
Roubaix
ZIP/Postal Code
59100
Country
France
Facility Name
Research facility ORG-001136
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
Research facility ORG-001089
City
Saint Nazaire
ZIP/Postal Code
44600
Country
France
Facility Name
Research facility ID ORG-001222
City
Sarreguemines
ZIP/Postal Code
57200
Country
France
Facility Name
Research facility ORG-001097
City
Sarreguemines
ZIP/Postal Code
57200
Country
France
Facility Name
Research facility ORG-001093
City
Toulon
ZIP/Postal Code
83100
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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