Autologous Fat Grafting Beneath Penile Split Thickness Skin Graft Placement During Penile Reconstruction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Pittsburgh
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ability to participate in informed consent
Loss of penile skin necessitating split-thickness skin grafting for reconstruction
Willingness to undergo the study interventions and comply with required study procedures
Is a medical and surgical candidate to undergo standard-of-care split-thickness skin graft reconstruction of the penis after standard preoperative optimization
Disqualifiers
History of neophallus creation
A diagnosed disorder of connective tissue or collagen deposition/formation
The inability to obtain sufficient fat from the surgical specimen or separate lipoharvest donor site to allow the autologous fat tissue processing
Any medical condition that would preclude safe conduct of the lipoharvest and/or injection procedure per investigator discretion
Trial design
Design model
Parallel
Treatments tested in this trial
Autologous fat grafting
Procedure/SurgeryIn this intervention, subjects will undergo their standard-of-care reconstructive urologic surgery with penile split-thickness skin grafting as medically indicated for treatment of their underline penile/genitourinary condition(s). In addition to this reconstruction, autologous fat grafting will be performed beneath their penile skin graft. 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.
Genitourinary Reconstruction with Split-Thickness Skin Grafting
Procedure/SurgerySubject eligibility for this study is contingent upon a baseline disease process in which subjects require and are appropriate for genitourinary reconstruction with penile split-thickness skin grafting as their surgical standard of care. Patients in both arms will receive the standard of care reconstruction and split-thickness skin grafting. The donor site for the split-thickness skin graft with be at the discretion of the operating surgeon during the case and will not be affected by enrollment and/or allocation within the trial.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: STSG AloneActive comparator 1 intervention
Group B: STSG with Autologous Fat GraftingExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Penile Tissue Pliability
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 millimeters.
Time frame
3 and 12 months postoperativelySecondary outcomes
1
Sexual Function
Subjects' postoperative sexual satisfaction and sexual function will be assessed using the 15-question validated International Index of Erectile Function questionnaire. Pre- and post-operative total scores (measured on a scale of 0 to 45, where a higher score indicates better sexual satisfaction/function) will be compared in a pairwise manner between arms of the study to determine if autologous fat grafting confers increase improvement on IIEF relative to the active comparator arm.
Time frame
Preoperatively, 3 months postoperatively, and 12 months postoperatively2
Urinary Function
The Internatonal Prostate Symptom Score (IPSS) validated patient questionnaire will be utilized to assess subjects' satisfaction with their urinary function. This questionnaire includes seven Likert-style questions assessing seven domains of urinary function, where a composite score of 0 represents no symptoms and a composite score of 35 represents maximum symptom burden. The questionnaire also contains one additional quality-of-life question, in which 0 represents maximum aggregate satisfaction with urinary function and 6 represents the worst possible satisfaction with urinary function. The pre- and post-operative scores will be analyzed in a pairwise manner, and the change in scores will be assess between the experimental and active comparator groups.
Time frame
Preoperatively, 3 months postoperatively, and 12 months postoperatively3
Genital Self-Image
Subjects' pre- and post-operative subjective genital self-image will be assessed using the 7-question validated Male Genital Self-Image Scale (MGSIS) questionnaire. Pre- and post-operative total scores (measured on a scale of 7 to 28, where a higher score represents a more positive self-image) will be compared in a pairwise manner between arms of the study to determine if autologous fat grafting confers increase improvement on MGSIS relative to the active comparator arm.
Time frame
Preoperatively, 3 months postoperatively, 12 months postoperatively4
Safety and Surgical Complications
Patient safety and surgical complications will be closely monitored throughout the convalescence period of the study in the standard manner for their genitourinary reconstruction procedure. Patients will be seen in-person, and contacted via telephone, for assessment of their wounds. At these visits, interval information will be collected to monitor for adverse events, such as graft failure, infection, incisional dehiscence, graft donor site hematoma, and other wound complications. All adverse events will be scored using the Clavien-Dindo classification system, and classified as minor (Clavien-Dindo 1-2) and major (Clavien-Dindo 3-5). The frequency of major and minor complications in the experimental arm will be compared to the frequency in the active comparator arm.
Time frame
Immediately postoperatively through 12 months, including in-person visits at 7 days, 4 weeks, 3 months, and 12 months postoperatively. A telephone call will also be initiated 6 months postoperatively.Sponsors and contacts
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Source ClinicalTrials.gov
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