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

• Register: ClinicalTrials.gov
• Last refreshed on: 28 March 2022
• Main ID: NCT02322710
• Date of registration: 19/12/2014
• Prospective Registration: No
• Primary sponsor: Mylan Inc.
• Public title: Comparison of Efficacy on Healing, and Safety of Two Dressings Urgotul and TulleGras MS on Surgical Acute Wounds.
• Scientific 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.
• Date of first enrolment: December 2014
• Target sample size: 208
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02322710
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Roger LESAUNIER, MD
• Affiliation: Mylan

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Surgical Acute Wounds

Intervention(s)

Device: TulleGras M.S.: Vaseline gauze

Device: Urgotul: Low-adherent dressing

Primary Outcome(s)

Percentage of Patients With Complete Healing (100% of Epithelialization). [Time Frame: Day 21]

Secondary ID(s)

LINE4002

2014-A00914-43

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Fovea

Results

• Results available: Yes
• Date Posted: 13/03/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02322710