Autologous Fat Grafting for Penile Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether adding a layer of fat beneath a skin graft can improve outcomes for men undergoing penile reconstructive surgery. Researchers aim to determine if this fat grafting increases skin flexibility, affects penile length, or enhances sexual and urinary functions. The study compares two groups: one receiving only the regular skin graft and another receiving both the graft and the additional fat layer. Men needing a skin graft due to lost penile skin and willing to try this new method might be suitable candidates. Participants will answer questions about their sexual and urinary health before and after surgery to help researchers assess the results. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future surgical outcomes.
What prior data suggests that autologous fat grafting is safe for penile surgery?
Research has shown that using one's own fat tissue, known as autologous fat grafting, to improve surgical results is generally safe. One study on penis enhancement surgery using fat grafts found it safe, with good cosmetic results and high patient satisfaction. Another study demonstrated that using fat grafts in men with thin penises was effective and did not cause major problems after surgery.
While these studies highlight the safety of using fat grafts, it's important to remember that any surgery can have risks. The specific trial you might join will carefully monitor for any issues during recovery. Always discuss potential risks with the trial team and your doctor before making a decision.12345Why are researchers excited about this trial?
Researchers are excited about autologous fat grafting in penile surgery because it offers a novel approach to genitourinary reconstruction. Unlike traditional methods that rely solely on split-thickness skin grafting, this technique involves using the patient's own fat tissue to enhance the grafting process. This method could potentially improve the aesthetic and functional outcomes by providing additional cushioning and support to the reconstructed area. Additionally, using the patient's own fat reduces the risk of rejection and complications, making it a promising alternative to current treatments.
What evidence suggests that autologous fat grafting might be an effective treatment for improving outcomes in penile reconstructive surgery?
This trial will compare two approaches for penile surgery: standard-of-care split-thickness skin grafting (STSG) alone and STSG with autologous fat grafting. Research has shown that using a person's own fat under skin grafts can aid healing. This method has succeeded in other body areas, enhancing skin graft results. Early findings suggest that using one's own fat can lead to better satisfaction and appearance compared to artificial materials. However, some cases may experience cosmetic issues, such as unevenness. Overall, adding a layer of fat might help the skin graft on the penis heal more naturally and improve results.12678
Who Is on the Research Team?
Paul J Rusilko, DO
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
Men scheduled for penile reconstructive surgery due to conditions like penile injury, phimosis, or hidden penis are eligible. Participants must be willing to complete questionnaires and undergo noninvasive skin testing during routine appointments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Initial Recovery
Participants undergo standard-of-care reconstructive surgery with or without autologous fat grafting, followed by initial recovery and wound care
Follow-up
Participants are monitored for safety, surgical complications, and functional outcomes, including sexual and urinary function, through questionnaires and noninvasive testing
Long-term Monitoring
Participants continue to be monitored for long-term outcomes and any late-onset complications
What Are the Treatments Tested in This Trial?
Interventions
- Autologous Fat Grafting
- Genitourinary Reconstruction with Split-Thickness Skin Grafting
Trial Overview
The trial is testing if adding a layer of the patient's own fat beneath a skin graft on the penis improves healing and outcomes. Half will receive this fat grafting with their surgery; the other half won't. They'll be compared over 12 months.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Subjects randomized to this arm of the study will undergo standard-of-care split-thickness skin grafting of their penis with autologous fat grafting. For subjects from whom a sufficient quantity of healthy adipose tissue is excised as part of the standard-of-care reconstructive surgery they have elected to undergo, the autologous fat graft will be processed from this specimen and placed between the skin graft and fascia of the penis. For subjects from whom a sufficient quantity of healthy adipose tissue is not excised as part of their standard-of-care reconstructive surgery, lipoaspiration (liposuction) will be performed to harvest fatty tissue that will subsequently undergo minimal processing for grafting.
Subjects randomized to this arm of the study will undergo standard-of-care split-thickness skin grafting of their penis without autologous fat grafting. They will undergo the same pre- and post-operative monitoring and complete the same testing as those in the experimental arm of the study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pittsburgh
Lead Sponsor
Citations
Autologous Fat Grafting Beneath Penile Split Thickness ...
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 ...
Complications and management of penile enhancement ...
This review offers practical, procedure-focused guidance on diagnosing and managing adverse events after injectable fillers, self-injection of ...
Autologous Fat Grafting Versus Alloplastic Materials in Post ...
According to our research, autologous fat grafting produces better results in terms of patient satisfaction, cosmetic appearance, and ...
Complication of Penile Injection of Autologous Fat
49,50 Wessells et al51 reported cosmetic complications of autologous fat transfer in 12 patients within 1 year of their penile augmentation procedures, ...
The evolution of penile reconstructive techniques in urology
... grafts, fat, or fascia over defect to restore penile function and appearance. Lowsley and Boyce reported 60% success rate but also over 20 ...
Complications of Genital Enlargement Surgery
Penile and scrotal enhancement surgery can be associated with major disabling complications, leading to deformity and functional compromise in men.
MP04-17 DERMAL FAT GRAFT FOR PENIS ...
Penis enhancement surgery with autologous dermal fat graft is safe procedure that provides good cosmetic outcome, and high rate of patient's satisfaction.
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journals.lww.com
journals.lww.com/plasreconsurg/fulltext/2012/11001/efficacy_and_safety_of_penile_girth_enhancement.127.aspxEfficacy and Safety of Penile Girth Enhancement byTwo- ...
TAFI operation for PGE in male patients with thin penises were effective and safe without postoperative major complications.
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