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

NCT04880603 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2022-05-13

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Acera Surgical, Inc.

    collaborator INDUSTRY

  • Nebraska Methodist Health System

    lead OTHER

Principal Investigators

  • Robert Lindau, MD · Nebraska Methodist Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-05
Primary Completion
2022-04-25
Completion
2022-04-25
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04880603 on ClinicalTrials.gov