Skin Graft ComplicationsNCT04648267
Factors Affecting Split Thickness Skin Graft Success Rates in Patients Who Underwent a Radial Forearm or Fibula Free Flap
A study testing Cast and bolster placement duration in people with Skin Graft Complications, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Graft Complications
- What is being tested?
- Cast and bolster placement duration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2021to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who underwent a radial forearm free flap or fibula free flap and split thickness skin graft placed over the donor site
Who cannot join
- Patients who cannot make informed decisions
- Patients who cannot make their one month post-operative appointment.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90033
About this study
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.
Read the 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
- Being tested
- Cast and bolster placement duration, Standard of care
- Keywords
- Split thickness skin graft, radial forearm free flap, fibula free flap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cast and bolster placement durationOther
The intervention is increasing the duration of cast and bolster placement on split thickness skin graft sites.
Standard of careOther
This will be standard of care - the patient will have his cast and bolster on for 5-7 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Standard of care |
| Experimental group | Experimental | Patients who have the cast and bolster on for 10-14 days Receives: Other: Cast and bolster placement duration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 that will be administered include the Rosenberg self-esteem survey. This is scored on a 4 point Likert scale. A higher score indicates higher self-esteem and a more favorable outcome
Measured: 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 that will be administered include the Short Form 36 quality of life form (SF 36). It is measured with 8 scales scores. Each scale is then transformed into a percentage from 0 to 100. A higher percentage indicates less disability and a more favorable outcome
Measured: The surveys will be administered once before surgery, once 1 month after surgery and once 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start5 Jan 2021
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Graft ComplicationsStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neils Kokot, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648267
- Sponsor's protocol ID
- HS-20-00490
- Status last verified
- Feb 2026
- First submitted
- 14 Nov 2020
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting Split Thickness Skin Graft Success Rates in Patients Who Underwent a Radial Forearm or Fibula Free Flap
- ClinicalTrials.gov ID
- NCT04648267
- Acronym / sponsor ID
- HS-20-00490
- Conditions
- Skin Graft Complications
- Keywords
- Split thickness skin graft, radial forearm free flap, fibula free flap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 1 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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"
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Standard of carePatients 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 |
| Experimental group | Experimental | Other: Cast and bolster placement durationPatients who have the cast and bolster on for 10-14 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients who underwent a radial forearm free flap or fibula free flap and split thickness skin graft placed over the donor site
Key exclusion criteria (2 listed)
- Patients who cannot make informed decisions
- Patients who cannot make their one month post-operative appointment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cast and bolster placement durationThe intervention is increasing the duration of cast and bolster placement on split thickness skin graft sites. | Other | Experimental group |
| Standard of careThis will be standard of care - the patient will have his cast and bolster on for 5-7 days | Other | Control group |
Primary outcome
The effect of cast and bolster duration on split thickness skin graft integration
Time frame: The patient will be assessed one month after surgery to take a picture of their skin grafts.
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
2 secondary outcomes
The effect of cast duration on self esteem
Time frame: 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
Time frame: The surveys will be administered once before surgery, once 1 month after surgery and once 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cast and bolster placement duration in people with Skin Graft Complications, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of cast and bolster duration on split thickness skin graft integration (time frame: The patient will be assessed one month after surgery to take a picture of their skin grafts.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.