25 Clinical Trials for Various Conditions
The purpose of RECOVER is to evaluate the performance and safety of Transorb™ self-gripping resorbable mesh in high-risk subjects (at least one risk factor impairing wound healing) when used for reinforcement of abdominal wall soft tissues in procedures involving open extraperitoneal ventral hernia repair, in clean (US); and clean and clean-contaminated (Europe) surgical fields (Centers for Disease Control and Prevention (CDC) Classification I and II. Data from this study will primarily be used to support market approval and European post-market clinical follow-up needs. Secondarily, data will be used for product marketing, future product development, and to support market release and maintenance in global geographies.
The purpose of this study is to use a scale to learn more about the tension of the abdominal wall in hernia repairs without component separation. 1. What is the abdominal wall tension for hernias repaired without a component separation? 2. What patient factors contribute to greater abdominal wall tension? 3. Is there an association between abdominal wall tension before primary closure or bridging repair and patient outcomes? Participants will be asked to allow their surgeon to use a tension scale to measure the tension of the abdominal wall during surgery.
The purpose of this study is to assess whether listening to music during surgery has an effect on pain or anxiety after surgery.
The primary objective of this study is to examine and compare the outcomes associated with the use of Flex HD®, a human acellular dermal matrix (HADM), and Strattice™, a porcine acellular dermal matrix, (PADM) when used as a reinforcing material in the repair of large complicated abdominal wall hernias.
This study is being done to test the efficacy of Symbotex™ as an effective synthetic mesh option in the repair of grade I and II ventral hernias.
The aim of this study is to evaluate the quality of life in patients with abdominal wall hernias using a user-friendly survey that is designed specifically for this population of patients. The investigators would like to use this survey to elucidate how quality of life of the patient is changed with the presence of an abdominal wall hernia.
The goal of this randomized controlled trial is to compare preoperative intensive weight management to upfront surgery in obese patients undergoing complex abdominal wall reconstruction. The main question is will abdominal wall specific quality of life (using the HerQLes survey) for the group undergoing upfront surgery be non-inferior compared to the group in the weight management program.
Restoring the physiologic tension of the abdominal wall is a key concept in abdominal wall reconstruction. Yet little is known quantitatively about the normal tension of the abdominal wall. To better understand the ideal tension for abdominal wall reconstruction, the physiologic tension of the abdominal wall needs to be measured. This study aims to measure the tension of the abdominal wall during laparotomy closure.
Number of patients with unsatisfactory pain relief defined as average visual analog scale (VAS) more than 5 with or without requirement of IVPCA for pain relief during the first 48 hours postoperative period will be compared between the two groups and form the primary outcome for the study. Postoperative pain intensity will be measured by Visual Analog Scale (VAS) with 0- being no pain and 10-being maximum pain and the analgesic efficacy in both groups will also be evaluated by the amount of total narcotic consumption (measured with IV morphine equivalent doses of analgesics used to provide pain relief).
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.
The main study objective is to determine the frequency of hernia recurrence following use of Veritas Collagen Matrix.
This is a prospective cohort study. Patients have an incisional or parastomal hernia with \>20 cm fascial defect on pre-operative imaging who will undergo an anticipated open bilateral transversus abdominis release with retromuscular synthetic mesh will have their abdominal wall tension measured using a tension scale and their intra-abdominal pressure measured using a urinary catheter containing pressure sensors. The investigators aim to quantify the changes, as well as explore and describe the physiologic shifts that may be associated with these changes.
The aim of the study is to determine if the usage of sugammadex would reduce the time to return of bowel function when compared to standard of care (neostigmine/glycopyrrolate) when used for neuromuscular blockade reversal in patients with open abdominal wall reconstruction (AWR).
The purpose of this study is to measure the changes in tension after each release in a standard posterior component separation during abdominal wall reconstruction.
This study aims to evaluate the potential role of physical therapy in improving outcomes after ventral hernia repair.
The purpose of this study is to determine how the patient factors, co-morbid conditions, pre-operative workup, anatomy of the defect, reconstruction details, operative techniques, and type of repairs contribute to the final outcome of abdominal wall reconstruction. The outcomes of interest are: in-hospital complications, discharge disposition, hospital and ICU length of stay, long term follow-up (recurrence, reoperation, and explantation rates).
Two different datasets from Institutional Review Board (IRB) approved studies L#12,083 and L#12,086 will be used to compare the sample characteristics between subjects who received Strattice mesh for abdominal wall reconstruction at Westchester Medical Center and Americas Hernia Society Quality Collaborative (AHSQC) registry.
Compare the ability of the transversus abdominis plane block (TAPB) and rectus sheath block (RSB) to provide surgical anesthesia for overweight and obese patients undergoing umbilical hernia surgery.
The aim of this study is to evaluate the short-term postoperative outcomes in the abdominal wall reconstruction population using an intraoperative local anesthetic infusion. A prospective randomized double blind study of patients undergoing component separation will be performed in order to assess the following outcomes: 1. Length of Stay (LOS) 2. Return of bowel function 3. Narcotic pain medication requirements 4. Nausea and emesis 5. Pain scores
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.
This study examines the feasibility of using Flex HD® Surgical Implant or STRATTICE® Reconstructive Tissue Matrixin the repair of hernias.
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.
Randomized controlled trial to compare SSO's in abdominal wall reconstruction patients using Prevena, Prineo, and traditional incisional dressings.
The purpose of this study is to show that the use of preoperative rectus sheath blocks can ultimately alleviate the need for using nondepolarizing muscle relaxants during certain abdominal procedures.
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.