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

Mylan

Status: Completed

Conditions: Surgical Acute Wounds

Treatments: Device: Urgotul: Low-adherent dressing; Device: TulleGras M.S.: Vaseline gauze

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02322710

2014-A00914-43 (Other Identifier)

LINE4002

Details and patient eligibility

About

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

Enrollment: 208 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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208 participants in 2 patient groups

TulleGras M.S.

Active Comparator group

Description:

Sterile dressing that consists of viscose tissue coated with mineral vaseline

Treatment:

Device: TulleGras M.S.: Vaseline gauze

Urgotul

Active Comparator group

Description:

Sterile, hydrocolloid dressing, that consists of a polyester fabric coated with hydrocolloid particles and vaseline

Treatment:

Device: Urgotul: Low-adherent dressing