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

NCT01597128 | Completed Results DMC

• 1 other identifier: 11-0080-P6A
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hernia Repair With Compartment Syndrome

Keywords

Hernia; human tissue; mesh

Outcome Measures

Primary Outcomes (10)

• Hernia Recurrence

  Recurrence of hernia based on physical exam and /or CT scan.

  12 months

• Wound Occurrence

  superficial or deep wound infection, abscess, seroma, cellulitis, necrosis, hematoma or wound dehiscence.

  12 months

• Wound Occurrence: Deep Wound Infection

  12 Months

• Wound Occurrence: Wound Abscess

  12 Months

• Wound Occurrence: Wound Seroma

  12 Months

• Wound Occurrence: Wound Cellulitis

  12 Months

• Wound Occurrence: Wound Dehiscence

  12 Months

• Wound Occurrence: Superficial Wound Infection

  Superficial wound infection

  12 months

• Change in SF12 Physical Component Score Between Pre-operation and 12 Months Post-operation

  Change in SF12 Physical Component Score from pre-operation to 12 months post-operation: Scores were normalized with 50 equal to the national norm and 40 equal to one standard deviation below the norm, so a 12 month difference of 10 would equal a 1 standard deviation change; An increase is better.

  12 months

• Change in SF12 Mental Component Score Between Pre-operation and 12 Months Post-operation

  Change in SF12 Mental Component Score from pre-operation to 12 months post-operation: Scores were normalized with 50 equal to the national norm and 40 equal to one standard deviation below the norm; An increase is better.

  12 months

Study Arms (2)

Flex HD

ACTIVE COMPARATOR

Mesh Type

Device: Flex HD

Strattice

ACTIVE COMPARATOR

Use of a second mesh type

Device: Strattice

Interventions

Flex HD DEVICE

Flex HD mesh for hernia repair

Flex HD

Strattice DEVICE

Strattice mesh for hernia repair

Strattice

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• John Roth: lead

Study Sites (1)

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

Related Links

• Musculoskeletal Transplant Foundation

MeSH Terms

Conditions

Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This is a Prospective Quasi-experimental study. Patients were randomized in the traditional sense.

Results Point of Contact

• Title: J. Scott Roth, M.D.
• Organization: University of Kentucky Medical Center

arockich@uky.edu

859-323-6346

Study Officials

• John S Roth, M.D.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: May 9, 2012
• First Posted: May 11, 2012
• Study Start: March 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: March 16, 2017
• Results First Posted: March 16, 2017

Record last verified: 2016-10

Locations

US (1)