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

NCT ID: NCT04648267

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-05
• Study Completion Date: 2025-11-30

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.

Detailed Description

This will be a prospective randomized control trial with a recruitment goal of 220 patients. One hundred and ten (110) patients will have undergone a split thickness skin graft (STSG) to reconstruct the fibula free flap (FFF) donor site and another one hundred and ten (110) patients will be for those with a radial forearm free flap (RFFF) donor site. This is anticipated to be a 5 year study.

Patients will be recruited in clinic. The study will be discussed at their pre-surgery evaluation visit and patients will be provided with a copy of the consent form to take home to discuss whether or not they wish to proceed with the study. On the day of the surgery, should the patients decide on joining the study, they will be consented and asked to fill out pre-surgery surveys. These surveys are the quality of life 36 item short form survey (SF 36) and a Rosenberg self-esteem survey.

Participants will be randomized to either the standard or the experimental group and this information will be placed in an opaque envelope attached to the consent. Participants then undergo surgery and receive routine post-operative care as per standard of care. After surgery on post operative day 1, one of the co-investigators will open the envelope which will reveal whether the participant is to have the cast and bolster for 5-7 days or 10-14 days. Participants who have their casts and bolsters on for 5-7 days will have them removed before discharge and those who are assigned to the longer group will have them taken off in clinic at their first post-operative visit.

At their one month follow up appointment, a picture will be taken of the donor site. Participants will also be asked to fill out a quality of life 36 item short form survey (SF 36) and a Rosenberg self-esteem survey directly on Redcap. Participants do not have to make extra trips to the physician's office. These pictures and surveys will be administered at their routine office visits. At 3 month, the participant will receive the same surveys again by mail or email, per their preference. Once they have completed these surveys at 3 months, they will have completed their portion of the study.

The investigators will then analyze the skin graft pictures on Adobe Photoshop. All of the photos of the grafts will be de-identified and the people analyzing the pictures will be blinded. They will estimate the percentage of the graft that has healed well or "take"

Conditions

Skin Graft Complications

Study Design

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

Study Groups

Control group

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

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: OTHER

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

Experimental group

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

Group Type: EXPERIMENTAL

Cast and bolster placement duration

Intervention Type: OTHER

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

Interventions

Cast and bolster placement duration

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

Intervention Type: OTHER

Standard of care

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Neils Kokot

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Southern California

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Liyang Tang

Role: CONTACT

liyang.tang@med.usc.edu

1-800-USC-CARES

Facility Contacts

Liyang Tang, MD

Role: primary

liyang.tang@med.usc.edu

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HS-20-00490

Identifier Type: -

Identifier Source: org_study_id