Treatment Trials

9 Clinical Trials for Various Conditions

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RECRUITING
Vascularized Composite Allotransplantation for Treatment of Abdominal Wall Defects
Description

Abdominal wall transplantation surgery is the transfer of abdominal wall tissues from a deceased human donor to a patient with a large abdominal wall defect. Abdominal wall transplantation is an innovative reconstructive procedure that has the potential to significantly improve the lives of patients with large abdominal wall defects. The purpose of this study is to develop the best practices for abdominal wall transplantation that will improve the outcomes of future abdominal wall transplant recipients.

COMPLETED
Feasibility Study of The Use of FLEX HD® Surgical Implant or STRATTICE® Reconstructive Tissue Matrix in The Closure of Abdominal Wall Defects With Component Separation in Clean or Contaminated Cases
Description

This study examines the feasibility of using Flex HD® Surgical Implant or STRATTICE® Reconstructive Tissue Matrixin the repair of hernias.

COMPLETED
A Retrospective Study Evaluating the Use of Permacol Surgical Implant in the Repair of Abdominal Wall Defects
Description

To evaluate short, mid and long term clinical outcomes associated with the use of Permacol in the treatment of abdominal wall defects.

COMPLETED
Change in Fascial Tension in Open Abdomens
Description

The goal of this observational study is to quantitatively measure the change in tension of the abdominal wall over time in subjects with open abdomens using a tensiometer.

RECRUITING
Abdominal Wall Transplant
Description

The purpose of this protocol is to determine the safety and efficacy of abdominal wall transplantation as a treatment for the reconstruction of abdominal wall defects. Abdominal wall transplantation may be performed alone or in combination with another transplant.

TERMINATED
Novel Strategies to Improve Immunomodulation and Non-invasive Clinical Monitoring in VCA
Description

The objective of this study is to develop a feasible and safe regimen for minimization of immune suppression in recipients of vascularized composite allotransplants (VCA) using a daily dose of recombinant IL-2. In order to achieve this aim, this trial will: 1. Perform VCA in 5 eligible subjects; 2. Administer recombinant IL-2 at a low-dose to promote the expansion and function of regulatory T cells in subjects who received VCA; and 3. Minimize immune suppression to tacrolimus single therapy in subjects who received VCA and recombinant IL-2. This trial will also investigate if it is possible to predict immune rejection in VCA using blood and tissue samples from recipients of VCA. Lastly, this trial will develop non-invasive technologies to monitor for VCA rejection. These technologies will involve magnetic resonance imaging. Multi-contrast ultra-high resolution MR imaging (MRI) with serial direct planimetry will be performed in recipients of VCA.

ACTIVE_NOT_RECRUITING
Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial
Description

The goal of this clinical trial is to evaluate the safety and feasibility of fetal repair of complex gastroschisis (GS) via a fetoscopic surgical approach by assessing maternal, fetal, neonatal, and infant outcomes in a cohort of 10 patients. The hypothesis is that in utero repair of GS will reduce postnatal mortality and morbidity in complex GS infants with minimal maternal and fetal risk.

Conditions
COMPLETED
RCT of Two Noncrosslinked Porcine Acellular Dermal Matrices in Ab Wall Reconstruction
Description

The purpose of the study is to compare the clinical outcomes of two commonly used, FDA-approved biologic meshes in hernia repair and abdominal wall reconstruction (Strattice and XenMatrix). The two meshes are derived from pig skin from which cells have been removed and which have been sterilized. The two meshes are made by two different companies using different processes.

UNKNOWN
Review of Complex Recurrent Hernia Repair
Description

Abdominal wall incisional hernia is a common finding in patients who have undergone previous intra-abdominal surgeries. Common methods of abdominal fascial closure include primary closure, mesh inlay versus onlay, with or without component separation. All these methods have been shown to have recurrence rates for hernia between 3%-60% in the literature. The study describes the investigators innovative and preferred method for reconstruction of the abdominal wall as BARS (bony anchoring reinforcement system). This method manages the abdominal fascial integrity to reduce the recurrence of incisional hernia while providing an aesthetically superior abdominal wall contour.