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NCT04648267 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by University of Southern California.

Completed
Registry status
NA
Development phase
75
Enrollment target

NCT04648267: Completed NA study, sponsored by University of Southern California.

NCT04648267 is a NA study that has completed, run by University of Southern California. The registered enrollment target is 75 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04648267, a NA study, has completed, sponsored by University of Southern California.

COMPLETED
Registry status
NA
Development phase
75 participants
Enrollment target

Study 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.

Primary Outcome

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

Interventions

  • OTHER Standard of care
  • OTHER Cast and bolster placement duration

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2021-01-05
Est. Completion 2025-11-30
Phase NA
University of Southern California

617 total trials

What the finished NCT04648267 record still lists

NCT04648267 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 2 interventions - of which Standard of care is the first listed.

NCT04648267 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04648267 about?

NCT04648267 is a clinical study titled "Factors Affecting Split Thickness Skin Graft Success Rates in Patients Who Underwent a Radial Forearm or Fibula Free Flap". 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 graf...

What is the current status of trial NCT04648267?

This trial is currently completed. It is a NA study. The enrollment target is 75 participants. The study started on 2021-01-05. Estimated completion is 2025-11-30.

What interventions are being tested in trial NCT04648267?

The interventions under investigation include: Standard of care (OTHER), Cast and bolster placement duration (OTHER).

Who is sponsoring clinical trial NCT04648267?

This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04648267's enrollment target sits among peer trials

75 1069th of 2000 higher than 919 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04648267, the US trial registry maintained by the National Library of Medicine. NCT04648267 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.