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

NCT ID: NCT04880603

Last Updated: 2022-05-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-05
• Study Completion Date: 2022-04-25

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A - Standard of Care

Group Type: ACTIVE_COMPARATOR

Standard of Care Skin Graft

Intervention Type: PROCEDURE

Standard of Care Skin Graft

B - Restrata Graft

Group Type: EXPERIMENTAL

Restrata Graft

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Standard of Care Skin Graft

Standard of Care Skin Graft

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• All patients age 19 or greater that will undergo radial forearm free flap or ulnar free flap.
• Photo documentation of wound bed at two weeks and four weeks must be obtainable either by physician or patient.

Exclusion Criteria

• Active systemic immunosuppression (active use of high-dose steroids (≥40mg prednisone daily or equivalent) or other immunosuppressive medications OR medical conditions causing immunosuppression, i.e. human immunodeficiency virus etc).
• Diabetes mellitus with most recent Hemoglobin A1c ≥10.0 within 30 days prior to surgery.
• Morbid obesity (BMI >40).
• Inability to maintain wrist immobilization for full planned period.
• Severe malnutrition (prealbumin levels <10 mg per dL within 30 days prior to surgery OR BMI <15 (very severely underweight).
• Other conditions felt to significantly impair wound healing per surgeon discretion

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acera Surgical, Inc.

INDUSTRY

Sponsor Role: collaborator

Nebraska Methodist Health System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Lindau, MD

Role: PRINCIPAL_INVESTIGATOR

Nebraska Methodist Hospital

Locations

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Countries

United States

Other Identifiers

Restrata

Identifier Type: -

Identifier Source: org_study_id