N/A
N=83
Repair of Infected or Contaminated Hernias
Hernia
Bottom Line
View on ClinicalTrials.gov: NCT00617357 ↗Enrolled (actual)
83
Serious AEs
62.5%
Results posted
Dec 2015
Primary outcome: Primary: Incidence of Wound Events — 53 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LTM (Strattice Reconstructive Tissue Matrix) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- LifeCell
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Wound Events |
53 | — |
| SECONDARY Activities Assessment Scale (AAS) |
82.0 | — |
| SECONDARY Activities Assessment Scale (AAS) |
82.0 | — |
| SECONDARY Activities Assessment Scale (AAS) |
82.0 | — |
| SECONDARY Activities Assessment Scale (AAS) |
82.0 | — |
| SECONDARY Activities Assessment Scale (AAS) |
82.0 | — |
| SECONDARY Activities Assessment Scale (AAS) |
82.0 | — |
Summary
This is a prospective, multicenter, interventional, observational, open label, single arm, longitudinal evaluation of ventral incisional hernia repair using LTM in contaminated or infected sites. Three interim analyses are planned to examine the incidence of surgical site events, postoperative resumption of activities and hernia recurrence.
Eligibility Criteria
Inclusion Criteria
- is an adult ≥18 years old.
- has need of open abdominal incisional repair of a contaminated or infected site
- has an estimated hernia size of >9cm2 by physical exam
Exclusion Criteria
- has a nidus of chronic colonization
- has a systemic infection at the time of repair.
- has chronic conditions: hepatic cirrhosis (w/ or w/o ascites); renal failure w/ hemo- or peritoneal dialysis; incomplete resection of malignant disease; or defined collagen disorder.
- requires chronic immunosuppressive therapy, including steroids or cytotoxic agents.
- is bedridden or otherwise non-ambulatory.
- is ASA Class 4 or 5.
- has a BMI >40.
- has conditions that would adversely affect subject safety, as per product labeling, including sensitivities to pork or porcine products.
Data sourced from ClinicalTrials.gov (NCT00617357). 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.