Deep Partial Thickness Burn Clinical Trial
Official title:
Open, Prospective, Randomised Investigation Evaluating Pain With the Use of 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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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