Comparison of Efficacy on Healing, and Safety of Two Dressings Urgotul and TulleGras MS on Surgical Acute Wounds.
NCT ID: NCT02322710
Last Updated: 2022-03-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
208 participants
INTERVENTIONAL
2014-12-31
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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TulleGras M.S.
Sterile dressing that consists of viscose tissue coated with mineral vaseline
TulleGras M.S.: Vaseline gauze
Urgotul
Sterile, hydrocolloid dressing, that consists of a polyester fabric coated with hydrocolloid particles and vaseline
Urgotul: Low-adherent dressing
Interventions
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Urgotul: Low-adherent dressing
TulleGras M.S.: Vaseline gauze
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Fovea
OTHER
Mylan Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Roger LESAUNIER, MD
Role: STUDY_DIRECTOR
Mylan
Locations
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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 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, , France
Research facility ID ORG-001220
Montreuil, , 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 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 ID ORG-001221
Paris, , France
Research facility ORG-001166
Pierre-Bénite, , 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, , France
Countries
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Other Identifiers
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2014-A00914-43
Identifier Type: OTHER
Identifier Source: secondary_id
LINE4002
Identifier Type: -
Identifier Source: org_study_id
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