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

Molnlycke Health Care

Status and phase

Completed

Phase 4

Conditions

Full Thickness Burns

Deep Partial Thickness Burn

Treatments

Device: Mepitel One

Study type

Interventional

Funder types

Industry

Identifiers

NCT01365273

MPTO 04

Details and patient eligibility

About

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.

Full description

Skin grafts are placed over excised areas of full thickness injuries and usually attached with sutures or staples. While useful in anchoring the graft in place, subjects often complain of pain from the staples as wound healing progresses.Pulling and sticking are common complaints.There is also a possibility that staples become embedded in the graft which leads to disruption of otherwise healed area, increased pain and anxiety for the subject as well as anxiety for the staff.

Graft take can be optimized with appropriate medical management. Use of non-adherent dressings to protect the graft is customary. Various types of netting-style are used, such as Bridal veil, a sterile product which is fixed over the graft with staples.

Silicone net dressings have also been used successfully to prevent lifting and adherence of skin grafts to the dressings, prevent pain and promote healing. Mepitel One is a sterile, transparent, and flexible wound contact layer consisting of perforated polyurethane film coated with Safetac soft silicone adhesive on one side. Mepitel One is available in various sizes and can be left in place for several days depending on the wound/skin condition.

Evaluation of burns will be performed at Baseline. Skin graft assessment will be performed at Day 7 and Day 14. End of study will be considered the time that graft is considered to have >95% take.

Enrollment

43 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Inclusion Criteria
1. Subjects presenting with 1% - 25% Total Body Surface Area (TBSA) deep partial or full-thickness burns requiring skin graft
2. 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)
3. Both genders with age ≥18 years but < 70 years
4. Signed informed consent

Exclusion criteria

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