Hernia Repair With Compartment Syndrome Clinical Trial
— Flex HDOfficial title:
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
| Verified date | December 2014 |
| Source | University of Kentucky |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
This study examines the feasibility of using Flex HD® Surgical Implant or STRATTICE® Reconstructive Tissue Matrixin the repair of hernias.
| Status | Active, not recruiting |
| Enrollment | 45 |
| Est. completion date | June 2016 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 85 Years |
| Eligibility |
Inclusion Criteria:• Have given written Informed Consent - Be 18-85 years of age (inclusive) - Patient has a ventral or incisional hernia with at least one of the following characteristics - Hernia is at least 6cm in transverse dimension - History of 2 or more prior ventral or incisional hernia repairs - Active or prior infection of the abdominal wall - Enterocutaneous fistula to the anterior abdominal wall - Mesh requiring mesh removal which would result in a hernia at least 6cm in transverse dimension - Patients is scheduled to undergo component separation hernia repair - Have an ASA Score of 3 or less - Have a BMI between 20 and 55 - Be a candidate for primary approximation of skin and wound following hernia repair - Have a life expectancy of at least 2 years Exclusion Criteria: - Have loss of abdominal domain such that the operation would be impractical or would adversely effect respiratory or cardiovascular function to an unacceptable degree - Be a candidate for emergency surgery that would make giving valid Informed Consent impractical - Be currently taking part in another clinical study that conflicts with the current study - Have active generalized peritonitis or intraperitoneal sepsis - Have active necrotizing fasciitis - Have active abdominal compartment syndrome - Have active untreated metabolic or systemic illness - Have known active malignancy present - Be unable to give valid informed consent or comply with required follow-up schedule - Suffer from mental capacity sufficiently severe to make informed consent unobtainable |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Kentucky Medical Center | Lexington | Kentucky |
| Lead Sponsor | Collaborator |
|---|---|
| University of Kentucky |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety | • Safety is estimated as the proportion of subjects who experience serious adverse events (SAEs) during the follow-up period of 12 months. Attempts will be made to determine if SAEs are related to the surgical procedure or are attributable to the mesh material. | 12 months | Yes |
| Secondary | Efficacy | Proportion of subjects experiencing a) clinical hernia repair failure (either laxity/bulging or hernia recurrence) or b) surgical site complication that requires intervention, or c) seroma. | 12 months | No |
| Secondary | Long Term Safety | Safety is estimated as the proportion of subjects who experience serious adverse events (SAEs) during the follow-up period of 12 months. Attempts will be made to determine if SAEs are related to the surgical procedure or are attributable to the mesh material. | up to 3.5 years | Yes |
| Secondary | Long Term Efficacy | Proportion of subjects experiencing a) clinical hernia repair failure (either laxity/bulging or hernia recurrence) or b) surgical site complication that requires intervention, or c) seroma. | up to 3.5 years | No |