[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"penissurgery\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:penissurgery":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100644965","a-novel-suspensory-ligament-penodermal-fixation-technique-versus-dorsal-tunica-albuginea-fixation-for-pediatric-buried-penis-100644965",false,"NCT07675915","A Novel Suspensory Ligament Penodermal Fixation Technique Versus Dorsal Tunica Albuginea Fixation for Pediatric Buried Penis:","A Novel Suspensory Ligament Penodermal Fixation Technique Versus Dorsal Tunica Albuginea Fixation for Pediatric Buried Penis: A Prospective Comparative Cohort Study","Inclusion Criteria:\n\n* Children under the age of 18 years diagnosed\n* Children with buried penis with parents seeking surgical treatment of this condition.\n\nExclusion Criteria:\n\n* History of previous penile surgery.\n* Patients with micro-penis.\n* Patients with other congenital anomalies such as hypospadias, epispadias and cryptorchidism.\n* Uncontrolled bleeding diathesis or patient who isn't fit for general anesthesia.\n* Buried penis due to excessive obesity.","MALE","2 Months","16 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"NA","The aim of the work to compare the outcomes of suspensory ligament fixation to the sub-dermis and dorsal tunica albuginea fixation in terms of success rate, need for auxiliary procedures, and complication rates in the buried penis.",[27,28,29],"Penis\u002FSurgery","Fixation","Ligament",[31,32,33,34],"Suspensory Ligament","Penodermal","Dorsal Tunica Albuginea Fixation","Pediatric Buried Penis","NOT_YET_RECRUITING","2026-06-23",{"date":38,"type":39},"2026-06-30","ACTUAL",{"date":38,"type":21},{"date":42,"type":21},"2027-07-30",{"name":44,"class":45},"Tanta University","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":46},"100617274","autologous-fat-grafting-beneath-penile-split-thickness-skin-graft-placement-during-penile-reconstruction-100617274","NCT07316491","Autologous Fat Grafting Beneath Penile Split Thickness Skin Graft Placement During Penile Reconstruction","Assessing Possible Improvements to Cosmetic and Functional Outcomes of Penile Split Thickness Skin Grafting With Autologous Fat Graft","Inclusion Criteria:\n\n* Ability to participate in informed consent\n* Loss of penile skin necessitating split-thickness skin grafting for reconstruction\n* Willingness to undergo the study interventions and comply with required study procedures\n* Is a medical and surgical candidate to undergo standard-of-care split-thickness skin graft reconstruction of the penis after standard preoperative optimization\n\nExclusion Criteria:\n\n* History of neophallus creation\n* A diagnosed disorder of connective tissue or collagen deposition\u002Fformation\n* The inability to obtain sufficient fat from the surgical specimen or separate lipoharvest donor site to allow the autologous fat tissue processing\n* Any medical condition that would preclude safe conduct of the lipoharvest and\u002For injection procedure per investigator discretion","18 Years",{"count":56,"type":21},24,[24],"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.\n\nQuestions the investigators hope to answer include:\n\n* Does fat grafting improve the pliability and feel of the penile skin after grafting\n* Does fat grafting change the penile length after surgery\n* Does fat grafting improve sexual function, urinary function, and genital self-image after surgery\n* Are there any unforeseen complications related to the fat grafting procedure\n\nParticipants 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.",[27,60,61,62],"Penis\u002FInjuries","Penile Skin","Adult-Acquired Buried Penis",[64,65,66],"Split-Thickness Skin Grafting","Autologous Fat Grafting","Penile Reconstruction","2026-04-28",{"date":69,"type":39},"2026-05-05",{"date":71,"type":21},"2026-06-01",{"date":73,"type":21},"2028-03-01",{"name":75,"class":45},"University of Pittsburgh",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":88,"conditions":89,"keywords":97,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":46},"100239468","phase-2-human-penile-allotransplantation-100239468","NCT02395497","Human Penile Allotransplantation","Donor Inclusion Criteria:\n\n* Males aged 16 - 65 years.\n* Brain dead meeting the criteria for Determination of Death.\n* Family consent for penile graft donation.\n* Stable donor (i.e., does not require excessive vasopressors to maintain blood pressure).\n* Same blood type as recipient.\n* Negative lymphocytotoxic crossmatch.\n* Accurately matched for skin tone\n\nRecipient Inclusion Criteria:\n\n* Males of any race, color or ethnicity; aged 18-69 years.\n* Recent (≥6 months) or remote (i.e., several decades) penile injury resulting in the loss of ≥75% of the phallus.\n* Penectomy secondary to penile cancer\n* Penile Cancer Survivors \\> 5 years\n* Micropenis associated with congenital\u002Fbirth defect and severely ambiguous male genitalia\n* Must have completed a clinic appointment with one of the study surgeons to discuss all penile reconstructive options.\n* Completes the protocol informed consent form(s).\n* No co-existing medical condition which, in the opinion of the study team, could affect the immunomodulatory protocol, surgical procedure, or functional results (If the condition is amenable to treatment, the study team must agree that said condition should not significantly enhance the surgical risks of penile transplantation.).\n* No co-existing psycho-social problems (i.e., alcoholism, drug abuse).\n* Negative for malignancy for past 5 years.\n* Negative for HIV at transplant.\n* Negative crossmatch with donor.\n* Consents to sample (i.e., skin biopsy) collection and storage and bone marrow infusion as part of the treatment regimen.\n* USA citizen or equivalent.\n* Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regimen.\n\nRecipient and Donor Exclusion Criteria:\n\n* Untreated sepsis.\n* HIV (active or seropositive).\n* Active tuberculosis.\n* Active Hepatitis B infection.\n* Hepatitis C.\n* Viral encephalitis.\n* Toxoplasmosis.\n* Malignancy (within past 5 years).\n* Current\u002Frecent (within 3 months of donation\u002Fscreening consent) IV drug abuse.\n* Paralysis of ischemic or traumatic origin.\n* Inherited peripheral neuropathy.\n* Infectious, post infectious, or inflammatory (axonal or demyelinating) neuropathy.\n* Toxic neuropathy (i.e. heavy metal poisoning, drug toxicity, industrial agent exposure).\n* Mixed connective tissue disease.\n* Severe deforming rheumatoid or osteoarthritis in the limb.\n\nDonor Only Exclusion Criteria:\n\n* Evidence of active herpes simplex virus-2 (HSV-2) infection.\n* Tattoos: non-professional tattoo within the last 6 months, or personally identifiable tattoo (i.e., donor name) on potential transplant.\n\nRecipient Only Exclusion Criteria:\n\n* Conditions that, in the opinion of the study team, may impact the immunomodulatory protocol potentially exposing the recipient to an unacceptable risk under immunosuppressive treatment.\n* Sensitized recipients with high levels (50%) of panel-reactive human leukocyte antigen (HLA) antibodies.\n* Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications including inherited coagulopathies like Hemophilia, Von-Willebrand's disease, Protein C and S deficiency, Thrombocythemias, Thalassemias, Sickle Cell disease, etc.\n* Conditions that may impact functional outcomes including Lipopolysaccharidosis and amyloidosis (may impact nerve regeneration).\n* Patients considered psychologically\u002Fpsychiatrically unsuitable.","69 Years",{"count":84,"type":21},60,[86,87],"PHASE2","PHASE3","Injuries to the genitalia are of concern to the military with emphasis placed on the surgical reconstruction and psychological health of these Wounded Warriors. However, despite significant surgical advances in microvascular surgery and autologous free tissue transfer, conventional reconstructions cannot truly replace the complicated structures and functions of the penis including the urethra, erogenous sensation, and erectile corporal bodies. Conventional reconstruction poses several challenges: patients may not have sufficient donor tissue due to other injuries or previous surgery; multiple operations are often needed to restore the neophallus; the final reconstruction only approximates the penis' native form; recreating the urethra is challenging and the new urethra is prone to stricture and fistula formation; the erectile function necessary for sexual intercourse is often lacking; and insufficient protective sensation can lead to penile implant extrusion, infection, subsequent explantation or loss of the reconstruction.\n\nThe investigators propose this clinical trial to determine functional outcomes and quality of life for Wounded Warriors and civilians who choose to undergo penile allotransplantation. The investigators will combine extensive experience performing total penile reconstruction in a large population affected by congenital, traumatic, and therapeutically extirpated Genitourinary deformities and expertise in reconstructive transplantation using an immunomodulatory protocol to for this study. The investigators anticipate penile transplantation can potentially replace \"like with like,\" restoring the appearance, anatomy, and function of the recipient in a manner far superior to autologous reconstruction. This project will establish the ability to perform penile allotransplantation using an immunomodulatory protocol and will compare outcomes with conventional phalloplasty patient results.\n\nStudy Design: This is a non-randomized subject self-controlled clinical trial to implement a cell-based immunomodulatory protocol for penile allotransplantation. An intermediate deliverable is achieving allograft survival and functional return with reduced dosing\u002Ffrequency of maintenance immunosuppression on steroid-free monotherapy (tacrolimus) immunosuppression. The long-term deliverable and goal is to demonstrate superior outcomes when compared to satisfaction and QOL in conventional phalloplasty patients 12-60 months post-transplant.",[90,91,92,93,94,95,27,60,96],"Amputation","Wounds and Injuries","Amputation, Traumatic","Urologic Surgical Procedures, Male","Amputation, Traumatic\u002FSurgery","Penis\u002FTransplantation","Congenital Anomaly, Male Genitalia",[98,99,100,101,90,102,103,104,105,106,107,108,109],"Penile Transplant","Vascularized Composite Allotransplantation (VCA)","Composite Tissue Allotransplantation (CTA)","Penis","Immunosuppression","Composite Tissue","Male","Humans","Allotransplantation","Micropenis","Severely Aambiguous Male Genitalia","congenital\u002Fbirth defect","RECRUITING","2025-07-03",{"date":113,"type":39},"2025-07-07",{"date":115,"type":39},"2014-06",{"date":117,"type":21},"2039-06",{"name":119,"class":45},"Johns Hopkins University"]