Assessing Possible Improvements to Cosmetic and Functional Outcomes of Penile Split Thickness Skin Grafting With Autologous Fat Graft
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Penile Tissue Pliability
研究概览
简要总结
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.
详细描述
The investigators seek to study a novel adipose-based therapeutic strategy to improve cosmetic and function outcomes at the time of penile split-thickness skin graft (STSG) application during penile reconstruction. This entails a therapeutic repurposing of commonly utilized fat and skin grafting protocols to provide a fat-first reconstruction to address each of these limitations in one simple, economical, and widely accessible treatment for point-of-care penile reconstruction. Autologous adipose tissue is ideal as an adjunct to penile split-thickness skin grafting because it: 1) provides immediate, biologic soft tissue coverage with minimal to no donor site burden; 2) remains viable in poorly vascularized wound beds and can be placed as a biologic dressing without specialized microsurgical care; 3) enhances angiogenesis to mitigate risk of infection of deeper structures; 4) mitigates adhesions to underlying structures; and 5) can be used as immediate platform for rapid restoration of cutaneous integrity. By leveraging these techniques, the investigators seek to provide a safe, effective, and available option to augment standard-of-care reconstruction techniques.
Multiple conditions can lead to a need for penile reconstruction. Penile trauma, including burns, penetrating injury, blast injury, and friction injury can irreversibly damage penile skin, leading to a need to resurface the shaft and/or glans of the penis with local tissue flaps or autologous grafts. Infectious processes, most notably Fournier's gangrene, can also lead to loss of penile skin. Finally, adult-acquired buried penis (AABP) disease, a condition wherein the penis becomes trapped by adjacent soft tissues leading to chronic inflammation and loss of penile epithelial integrity, can require surgical excision of penile skin as part of a multicomponent repair. In all of these cases, STSG of the penile shaft is considered standard of care if local flaps, such as scrotal flaps, are not available for reconstruction due to overlapping disease processes. STSGs are commonly utilized to allow for rapid, definitive closure and restoration of the integument.
While STSG graft take on the penis following these processes is successful >95% of the time with restoration of urinary outcomes, patients who have undergone the procedure typically report dissatisfaction with the cosmetic appearance of their penile skin. This is due to adhesion of the STSG to the fixed Buck's deep fascia of the penis, which occurs due to the loss of the mobile Dartos fascia during the time of initial insult/injury. The combination of adhesion and graft contracture/fibrosis can lead to a "plasticky" feeling of the penile skin, which is especially bothersome given the expansile nature of the deep cavernosal bodies during sexual arousal. While current sexual outcomes in patients undergoing penile reconstruction are superior to patients who do not undergo reconstruction, there exists significant room for improvement. There currently exist no off-the-shelf products with proven efficacy in improving outcomes.
Adipose tissue is a prime candidate for this application due to its autologous origin, ease of procurement with minimal-to-no additional donor site morbidity, and abundant availability in patients, alongside its unique reconstructive and regenerative capacities. The use of autologous adipose in delayed tissue reconstruction is well established. However, the full therapeutic potential of adipose tissue remains underexploited. Fat grafting provides immediate soft tissue bulk, enhances angiogenesis, is both immunomodulatory and enhances immunologic homing, and supplies mesenchymal cells for soft tissue healing. Fat grafting is viable in hostile recipient beds including infected/contaminated and poorly vascularized wounds such as the diabetic foot ulcer, irradiated skin, and burn scars.
Grafting of autologous fat tissue is a minimally invasive surgical technique that starts with the harvest of small particles (2-5 mm) of fat tissue from the abdomen or using liposuction. Sometimes, fat graft can be harvested from tissue that is removed for other reasons. This technique utilizes incisions smaller than 5 mm in length and rapid intraoperative processing allowing for immediate transplantation of a patient's own tissue in a single operative procedure. Autologous fat can also be obtained from adipose tissue removed intraoperatively, which is a standard component to AABP repair, and processed intraoperatively for immediate use. This follows a standard fat grafting preparation protocol currently being used for standard of care cases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
STSG Alone
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.
干预措施: Genitourinary Reconstruction with Split-Thickness Skin Grafting (Procedure)
STSG with Autologous Fat Grafting
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.
干预措施: Autologous fat grafting (Procedure)
STSG with Autologous Fat Grafting
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.
干预措施: Genitourinary Reconstruction with Split-Thickness Skin Grafting (Procedure)
结局指标
主要结局
Penile Tissue Pliability
时间窗: 3 and 12 months postoperatively
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.
次要结局
- Sexual Function(Preoperatively, 3 months postoperatively, and 12 months postoperatively)
- Urinary Function(Preoperatively, 3 months postoperatively, and 12 months postoperatively)
- Genital Self-Image(Preoperatively, 3 months postoperatively, 12 months postoperatively)
- Safety and Surgical Complications(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.)
- Stretched Penile Length(Intraoperatively, 3 months postoperatively, 12 months postoperatively)
- Penile Pain and Sensitivity to Monofilament Testing(3 and 12 months postoperatively)
- Penile Sensitivity to Two-Point Discrimination Testing(3 and 12 months postoperatively)
- Penile Graft Elasticity(3 and 12 months postoperatively)
研究者
Paul Rusilko
Director of Reconstructive Urology, Associate Professor of Urology
University of Pittsburgh
