Factors Affecting Split Thickness Skin Graft Success Rates in Patients Who Underwent a Radial Forearm or Fibula Free Flap

NCT04648267 | Completed

• 1 other identifier: HS-20-00490
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Fibula free flaps (FFF) and radial forearm free flaps (RFFF) are necessary to reconstruct parts of the face after cancer surgery, traumas, or debilitating infections. Oftentimes, after we take the flap from the arm or leg, there is a large skin defect that must be filled. A split thickness skin graft (STSG) usually from the thigh can be used to fill this defect. Split thickness skin grafts get their blood supply from the underlying tissue, Hence, pressure must be applied to the skin grafts to ensure that they "stick" to the underlying tissue and are properly perfused. A bolster and cast is placed onto the skin graft to apply pressure and to immobilize the skin graft to optimize healing. However, skin grafts still often do not take well. Thus, the objective of this study is to see if the duration of the cast and bolster over the skin graft has an effect on how well it integrates into the wound bed. The study will compare 2 groups: the standard of care 5-7 day cast group versus the experiment 10-14 day cast group. The hypothesis is that people with longer cast and bolster duration will have better healing rates. Surveys will also be administered to see if cast and bolster duration will affect quality of life and self-esteem.

Conditions

Skin Graft Complications

Keywords

Split thickness skin graft; radial forearm free flap; fibula free flap

Outcome Measures

Primary Outcomes (1)

• The effect of cast and bolster duration on split thickness skin graft integration

  At one month, we will take pictures in clinic of the split thickness skin graft. Afterwards, two blinded investigators will determine how much of the skin graft has integrated. Exposed tendon and muscle indicate that that part of the skin graft has failed. This will be done on Adobe Photoshop and the integration percentage will be scored. The scale will be from 0% to 100%. A higher percentage is a better outcome

  The patient will be assessed one month after surgery to take a picture of their skin grafts.

Secondary Outcomes (2)

• The effect of cast duration on self esteem

  The surveys will be administered once before surgery, once 1 month after surgery and once 3 months after surgery

• The effect of cast duration on quality of life

  The surveys will be administered once before surgery, once 1 month after surgery and once 3 months after surgery

Study Arms (2)

Control group

ACTIVE COMPARATOR

Patients who have the cast and bolster on for standard 5 days after their radial forearm free flap and 7 days after their fibula free falp

Other: Standard of care

Experimental group

EXPERIMENTAL

Patients who have the cast and bolster on for 10-14 days

Other: Cast and bolster placement duration

Interventions

Cast and bolster placement duration OTHER

The intervention is increasing the duration of cast and bolster placement on split thickness skin graft sites.

Experimental group

Standard of care OTHER

This will be standard of care - the patient will have his cast and bolster on for 5-7 days

Control group

Eligibility Criteria

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

You may qualify if:

• Adult patients who underwent a radial forearm free flap or fibula free flap and split thickness skin graft placed over the donor site

You may not qualify if:

• Patients who cannot make informed decisions
• Patients who cannot make their one month post-operative appointment.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

MeSH Terms

Interventions

POLR1G protein, human; Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigators evaluating the skin grafts with adobe photoshop will be masked and will not know which skin graft belonged to which patient
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 14, 2020
• First Posted: December 1, 2020
• Study Start: January 5, 2021
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (1)