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OpenTrials
Completed

NCT Number: NCT02322710

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research facility ID ORG-001264, Ajaccio, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Urgotul: Low-adherent dressing

Device

TulleGras M.S.: Vaseline gauze

Device

Primary outcomes

  1. Percentage of Patients With Complete Healing (100% of Epithelialization).

    Time frame: Day 21

    Using photographs,independent assessor blinded assessment.

Sponsors and collaborators

Lead sponsor

Mylan Inc.

Industry

Collaborators

  • Fovea

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 23, 2014
Registry last updated
Mar 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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