NCT02994589

A Comparison of OASIS Wound Matrix With Approved Dressings for Skin Graft Donor Sites

A Comparison of OASIS Wound Matrix With Approved Dressings for Split Thickness Skin Graft Donor Sites

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Loma Linda University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The investigators objective is to compare OASIS wound matrix with other commonly used dressings available for the donor site in split thickness skin grafting in order to determine which dressing provides the best outcome based on pain level, time to healing and aesthetic outcome.

Detailed description

Investigators seek to compare Oasis wound matrix with Tegaderm and Xeroform in order to determine whether advantages exist in one or more of the dressing types that are approved and currently used for split-thickness skin graft donor site dressings. Patients will be randomly assigned to one of the three treatment groups and followed up post-operatively and treated as per current standard of care. Data to be collected and analyzed includes: patient age, co-morbid illnesses, medication, skin-graft donor location, skin-graft donor area, STSG thickness, infection rate, complications involving the donor site, post-operative pain score every morning until hospital discharge, healing rate, photographs of the donor site immediately post-operatively and then at routine follow-up appointments.

Conditions

• Skin Graft Complications

Interventions

Type	Name	Description
OTHER	Tegaderm™(Absorbant, 3M)	3M™ Tegaderm™ Dressing helps provide the natural moisture balance conducive to wound healing.
DEVICE	OASIS® wound matrix	OASIS® Matrix is indicated for the management of wounds including: partial- and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), draining wounds, surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence).
OTHER	Xeroform™	Xeroform™ consists of a fine-mesh gauze impregnated with bismuth tribromophenate.

Timeline

• Start date: 2016-10-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-12-16
• Last updated: 2016-12-16