N/A N=35 Treatment

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

Bottom Line

View on ClinicalTrials.gov: NCT01597128 ↗

Enrolled (actual)

Serious AEs

5.7%

Results posted

Mar 2017

Primary outcome: Primary: Hernia Recurrence — 11; 12 percentage of patients

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Flex HD (Device); Strattice (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: John Roth
Primary completion: May 2015

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	—

Summary

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

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

View full record on ClinicalTrials.gov →

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.