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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-09

Study Completion Date

2022-01-01

Brief Summary

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Understand association between use of Restrata (Acera Surgical Inc., St. Louis, MO) in forearm flap reconstruction with donor site healing and function

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Detailed Description

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Conditions

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Wound Heal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Restrata with a split-thickness skin graft

Group Type EXPERIMENTAL

Restrata

Intervention Type DEVICE

Restrata is a sterile, single use device intended for use in local management of wounds

Split-thickness skin graft alone

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Restrata

Restrata is a sterile, single use device intended for use in local management of wounds

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. 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).
2. Diabetes mellitus with most recent Hemoglobin A1c ≥10.0 within 30 days prior to surgery.
3. Morbid obesity (BMI \>40).
4. Inability to maintain wrist immobilization for full planned period.
5. Severe malnutrition (prealbumin levels \<10 mg per dL within 30 days prior to surgery OR BMI \<15 (very severely underweight).
6. Other conditions felt to significantly impair wound healing per surgeon discretion.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No