Open, Prosp, Rand. Invest. Evaluating Pain With Mepitel One vs.Bridal Veil and Staples on Split Thickness Skin Grafts

Completed · Phase 4

Conditions studied: Deep Partial Thickness Burn, Full Thickness Burns

In brief

This investigation is an open, randomised investigation. Approximately 40 subjects in 4-5 centres in the US with deep-partial of full thickness burns in need of skin grafts will be enrolled.The subjects will be equally randomised to either treatment with Mepitel One or bridal veil together with staples. The primary objective is to compare pain at the time of dressing change for the use of Mepitel One versus bridal veil together with staples on deep partial or full thickness burns requiring skin grafts.

Key facts

Study ID

NCT01365273

Run by

Molnlycke Health Care AB

People needed

43

Starts

2011-02-01

Expected to finish

2011-12-01

Last updated by the study team

2014-02-13

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion Criteria
• Subjects presenting with 1% - 25% Total Body Surface Area (TBSA) deep partial or full-thickness burns requiring skin graft
• At least 1%-10% TBSA is available for grafting that can be considered for study site selection (must have intact, healthy peri-wound area around entire portion of this burned site)
• Both genders with age ≥18 years but < 70 years
• Signed informed consent

You may not qualify if…

• Subjects with chronic wounds
• Subjects who are on mechanical ventilation
• Subjects with dermatologic skin conditions or necrotizing disorders
• Diagnosed underlying disease(s) (HIV/AIDS, cancer and severe anaemia)judged by the investigator to be a potential interference in the treatment
• Subjects treated with systemic glucocorticosteroids, except subjects taking occasional doses or doses less than 10 mg prednisolon/day or equivalent
• Use of immunosuppressive agents, radiation or chemotherapy within the past 30 days
• Known allergy/hypersensitivity to any of the components of the investigational products
• Subjects with physical and/or mental conditions that are not expected to comply with the investigation
• Participation in other clinical investigation(s) within 1 month prior to start of the investigation
• Previously randomised to this investigation
• Pregnancy

Where it is running

• University Foundation for Education & Research, Inc — Tampa, Florida, United States
• Joseph M. Still Research Foundation, Inc. — Augusta, Georgia, United States
• 5028 Delp Bldg, Mail stop 1011 — Kansas City, Kansas, United States
• Natham Speare Regional Burn Treatment Ctr., Crozer Chester Medical Center — Upland, Pennsylvania, United States

Full record on ClinicalTrials.gov

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