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

NCT04880603 | Terminated Phase 2 FDA Device

• 1 other identifier: Restrata
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Tendon exposure

  Tendon exposure at four weeks post-operatively (Yes/No).

  4 weeks post-operation

• Percentage of surface area

  Percentage of surface area of split-thickness skin graft incorporation at four weeks postoperatively.

  4 weeks post operation

Study Arms (2)

A - Standard of Care

ACTIVE COMPARATOR

Procedure: Standard of Care Skin Graft

B - Restrata Graft

EXPERIMENTAL

Device: Restrata Graft

Interventions

Restrata Graft 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.

B - Restrata Graft

Standard of Care Skin Graft PROCEDURE

Standard of Care Skin Graft

A - Standard of Care

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nebraska Methodist Health System: lead
• Acera Surgical, Inc.: collaborator

Study Sites (1)

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Robert Lindau, MD

  Nebraska Methodist Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 11, 2021
• Study Start: April 5, 2021
• Primary Completion: April 25, 2022
• Study Completion: April 25, 2022
• Last Updated: May 13, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)