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NCT07316491 · ClinicalTrials.gov registry record · NA
Autologous Fat Grafting Beneath Penile Split Thickness Skin Graft Placement During Penile Reconstruction
A NA study, sponsored by University of Pittsburgh.
- Not yet
- Registry status
- NA
- Development phase
- 24
- Enrollment target
NCT07316491: Clinical Trial NA study, sponsored by University of Pittsburgh.
NCT07316491 is a NA study that has not yet begun recruiting, run by University of Pittsburgh. The registered enrollment target is 24 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07316491, a NA study, has not yet begun recruiting, sponsored by University of Pittsburgh.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
Study Summary
The goal of this randomized interventional clinical trial is to learn if placement of a thin layer of fatty tissue (fat graft) beneath a split-thickness skin graft on the surface of the penis improved outcomes of surgery in men who are scheduled to undergo reconstructive surgery on their penis and genitals. This is a randomized study, meaning that half of participants will receive the fat graft with their standard-of-care surgery, and half will have their standard-of-care surgery alone. Fat grafting underneath split-thickness skin grafts in other parts of the body has been shown to improve healing of the skin graft. Both study groups will be followed for specific outcomes through outpatient clinic visits for the first 12 months after their surgery, as well as chart review. Questions the investigators hope to answer include: * Does fat grafting improve the pliability and feel of the penile skin after grafting * Does fat grafting change the penile length after surgery * Does fat grafting improve sexual function, urinary function, and genital self-image after surgery * Are there any unforeseen complications related to the fat grafting procedure Participants will be asked to complete questionnaires related to sexual, urinary, and genital self-image questionnaires before surgery, 3 months after surgery, and 12 months after surgery. Noninvasive testing of the penile skin will also be performed at participants' routine appointments.
Primary Outcome
The primary outcome of this study will be cutometric assessment of penile tissue pliability following split-thickness skin grafting. This will be measured using established noninvasive, nondestructive techniques that are not expected to cause significant discomfort or distress to patients. The numeric outcome of this, as measured in millimeters, will be directly compared between the experimental and active comparator arms. More pliability is manifested as increased pliability, as measured in mil
Interventions
- PROCEDURE Autologous fat grafting
- PROCEDURE Genitourinary Reconstruction with Split-Thickness Skin Grafting
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2026-06-01 |
| Est. Completion | 2028-03-01 |
| Phase | NA |
What is known before NCT07316491 opens enrollment
NCT07316491 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Autologous fat grafting is the first listed.
NCT07316491 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07316491 about?
NCT07316491 is a clinical study titled "Autologous Fat Grafting Beneath Penile Split Thickness Skin Graft Placement During Penile Reconstruction". The goal of this randomized interventional clinical trial is to learn if placement of a thin layer of fatty tissue (fat graft) beneath a split-thickness skin graft on the surface of the penis improved outcomes of surgery in men who are scheduled to undergo reconstructive surgery on their penis and g...
What is the current status of trial NCT07316491?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 24 participants. The study started on 2026-06-01. Estimated completion is 2028-03-01.
What interventions are being tested in trial NCT07316491?
The interventions under investigation include: Autologous fat grafting (PROCEDURE), Genitourinary Reconstruction with Split-Thickness Skin Grafting (PROCEDURE).
Who is sponsoring clinical trial NCT07316491?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07316491's enrollment target sits among peer trials
24 1736th of 2000 higher than 246 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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