Open, Prosp, Rand. Invest. Evaluating Pain With Mepitel One vs.Bridal Veil and Staples on Split Thickness Skin Grafts
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.
Deep Partial Thickness Burn
Full Thickness Burns
Device: Mepitel One
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open, Prospective, Randomised Investigation Evaluating Pain With the Use of Mepitel One vs.Bridal Veil and Staples on Split Thickness Skin Grafts|
- VAS Score for Pain Before Dressing Removal [ Time Frame: At visit 6, day 7 ] [ Designated as safety issue: Yes ]Pain was measured with Visual Analogue Scale (VAS)(100 mm) measuring from 0 = "no pain" at one end to 100 = "most intense pain imagaginable" at the other end.
- VAS Score for Pain During Dressing Removal [ Time Frame: Visit 6, day 7 ] [ Designated as safety issue: Yes ]Pain when half of the study product(s) has been removed measued with Visual Analogue Scale (VAS).0 = "no pain" till 100 = "worst pain".
- VAS Score for Pain After Dressing Removal [ Time Frame: Visit 6, day 7 ] [ Designated as safety issue: Yes ]Pain after the dressing removal measued with Visual Analogue Scale (VAS).0 = "no pain" till 100 = "worst pain".
|Study Start Date:||February 2011|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
No Intervention: Bridal Veil together with staples
Standard of care. Bridal Veil is fixed over the graft with staples.
Active Comparator: Mepitel One
Device: Mepitel One
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365273
|United States, Florida|
|University Foundation for Education & Research, Inc|
|Tampa, Florida, United States, 33606|
|United States, Georgia|
|Joseph M. Still Research Foundation, Inc.|
|Augusta, Georgia, United States, 30909|
|United States, Kansas|
|5028 Delp Bldg, Mail stop 1011|
|Kansas City, Kansas, United States, 66160|
|United States, Pennsylvania|
|Natham Speare Regional Burn Treatment Ctr., Crozer Chester Medical Center|
|Upland, Pennsylvania, United States, 19013|
|Principal Investigator:||Mary Lou Patton, MD||Nathan Speare Regional Burn Treatment Ctr. Croer Chester Medical Center|