Overview

This trial is active, not recruiting.

Condition surgical acute wounds
Treatments urgotul: low-adherent dressing, tullegras m.s.: vaseline gauze
Phase phase 4
Sponsor Mylan Inc.
Collaborator Fovea
Start date December 2014
End date October 2016
Trial size 208 participants
Trial identifier NCT02322710, 2014-A00914-43, LINE4002

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Sterile dressing that consists of viscose tissue coated with mineral vaseline
tullegras m.s.: vaseline gauze
(Active Comparator)
Sterile, hydrocolloid dressing, that consists of a polyester fabric coated with hydrocolloid particles and vaseline
urgotul: low-adherent dressing

Primary Outcomes

Measure
Percentage of patients with complete healing (100% of epithelialization).
time frame: D21

Secondary Outcomes

Measure
Time to complete healing (100% epithelialization)
time frame: At each visit (D1, D21)
Quality of healing according to Vancouver scale
time frame: D21
Frequency of painless dressing removal (pain < 30 mm on 100 mm VAS)
time frame: During first three removals
Safety and tolerability of the dressings
time frame: At each visit (D1, D21)

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Mylan Inc..