NCT04880603

Utility of Restrata With Split-thickness Skin Graft to Reconstruct the Forearm Donor Site

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Nebraska Methodist Health System · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Adult patients undergoing a radial forearm free flap or ulnar forearm free flap will be randomized to the use of the Restrata graft in combination with split-thickness skin graft for reconstruction. Photos will document whether the Restata graft aids in the healing.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DEVICE	Restrata Graft	Restrata will be meshed in a 1:2 fashion to allow for egress of serous fluid and minimize risk of fluid collection. Restrata will be applied to the entire wound bed not amenable to primary closure and will be underlaid beneath the surrounding skin edges. A split-thickness skin graft is harvested from patient's thigh at 15:1000 inches and placed on top of the Restrata to cover the entire wound bed. The graft is sutured in place using suture choice of surgeon's preference.
PROCEDURE	Standard of Care Skin Graft	Standard of Care Skin Graft

Timeline

• Start date: 2021-04-05
• Primary completion: 2022-04-25
• Completion: 2022-04-25
• First posted: 2021-05-11
• Last updated: 2022-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study