N/A
Completed N=35
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
Hernia Repair With Compartment Syndrome
Source: ClinicalTrials.gov NCT01597128 ↗
Enrolled (actual)
35
Serious AEs
5.7%
Results posted
Mar 2017
Primary outcomePrimary: Hernia Recurrence — 11; 12 percentage of patients
Summary
This study examines the feasibility of using Flex HD® Surgical Implant or STRATTICE® Reconstructive Tissue Matrixin the repair of hernias.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hernia Recurrence |
11; 12 | — |
| PRIMARY Wound Occurrence |
17; 29 | — |
| PRIMARY Wound Occurrence: Deep Wound Infection |
0; 6 | — |
| PRIMARY Wound Occurrence: Wound Abscess |
11; 18 | — |
| PRIMARY Wound Occurrence: Wound Seroma |
11; 12 | — |
| PRIMARY Wound Occurrence: Wound Cellulitis |
0; 6 | — |
| PRIMARY Wound Occurrence: Wound Dehiscence |
11; 0 | — |
| PRIMARY Wound Occurrence: Superficial Wound Infection |
17; 29 | — |
| PRIMARY Change in SF12 Physical Component Score Between Pre-operation and 12 Months Post-operation |
3; 2 | — |
| PRIMARY Change in SF12 Mental Component Score Between Pre-operation and 12 Months Post-operation |
0; 6 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01597128). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.