N/A
N=204
Comparison of Efficacy on Healing, and Safety of Two Dressings Urgotul and TulleGras MS on Surgical Acute Wounds.
Surgical Acute Wounds
Bottom Line
View on ClinicalTrials.gov: NCT02322710 ↗Enrolled (actual)
204
Serious AEs
10.3%
Results posted
Mar 2019
Primary outcome: Primary: Percentage of Patients With Complete Healing (100% of Epithelialization). — 77; 67 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Urgotul: Low-adherent dressing (Device); TulleGras M.S.: Vaseline gauze (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mylan Inc.
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Complete Healing (100% of Epithelialization). |
77; 67 | — |
Summary
Evaluation of non-inferiority on healing rates of two dressings Urgotul and TulleGras MS in the treatment of surgical acute wounds.
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 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.
Data sourced from ClinicalTrials.gov (NCT02322710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.