Comparative Study of Biologic Mesh Versus Repair With Component Separation.

NCT01295125 | Terminated Results DMC

• 1 other identifier: 11-10-23
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare open abdominal incisional hernia repair using XenMATRIX biologic mesh versus repair with their own tissue. This study will provide information in determining if a biological mesh is necessary to provide a sturdy repair for a ventral hernia.

Conditions

Ventral Hernia

Keywords

Infected ventral hernia; Contaminated incisional hernia

Outcome Measures

Primary Outcomes (1)

• The Incidence of Postoperative Hernia Recurrence

  two years after surgery date

Secondary Outcomes (5)

• Compare the Short-term Clinical Outcomes of Postoperative Wound Events

  two years after surgery date

• Length of Hospital Stay

  Number of days up to 1 week

• Length of Resource Utilization

  two years after surgery date

• Antibiotic Usage and Days

  two years after surgery date

• Resumption of Activities of Daily Living

  two years after surgery date

Study Arms (1)

XenMATRIX

EXPERIMENTAL

Use of XenMATRIX mesh to repair hernia

Device: XenMATRIX mesh; Procedure: Open abdominal ventral hernia repair

Interventions

XenMATRIX mesh DEVICE

Use of XenMATRIX mesh in the repair of contaminated ventral hernia repair

Also known as: Davol Biologic mesh

XenMATRIX

Open abdominal ventral hernia repair PROCEDURE

Abdominal ventral hernia repair with native tissue

Also known as: Abdominal ventral hernia repair with native tissue

XenMATRIX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is an adult ≥ 18 years old of either gender
• Will undergo a planned open abdominal incisional hernia repair
• Has a defect that can be repaired primarily without tension with myofascial advancement flaps and requires no more than 1 piece of surgical mesh (largest mesh size (19 x 35 cm)
• Contamination is known preoperatively, e.g. repair in the presence of a chronic wound, the presence of a stoma or in conjunction with a bowel resection, or such contaminations occurs intraoperatively, e.g. inadvertent enterotomy or opening of other hollow intra-abdominal viscus
• Infection is known due to local frank signs of incisional drainage, fistula formation or abdominal abscess following prior surgical abdominal surgery or presence of infected mesh
• Has an estimated hernia size of ≥ 3cm to 20cm in maximal width by physical exam
• Is considered a clean-contaminated or contaminated case per Surgical Site Infection Risk Guidelines
• Is willing and able to return for all scheduled and required study visits
• Is willing and able to provide written informed consent for study participation

You may not qualify if:

• Has a defect that the surgeon cannot achieve primary fascial apposition and requires a bridge of mesh
• Is a clean or dirty case per Surgical Site Infection Risk Guidelines
• Has conditions that would adversely affect subject safety as per product labeling
• Will undergo a laparoscopic hernia repair
• Has a nidus of chronic colonization, such as chronic indwelling bladder catheter or significant amounts of non-removable infected mesh
• Has conditions which preclude abdominal imaging at a standard imaging facility
• Has an anticipated survival of \< 24 months
• Care plan is to perform a staged repair over 45 days
• Is bedridden or otherwise non-ambulatory (i.e. is unable to independently transfer into and out of a wheelchair)
• Is ASA class 4 or 5
• BMI over 45
• Is pregnant

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Bard Ltd: collaborator

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Michael Rosen
• Organization: University Hosptials Cleveland Medical Center

rosenm@ccf.org

216-396-9937

Study Officials

• Michael J. Rosen, MD.

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2011
• First Posted: February 14, 2011
• Study Start: January 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: January 25, 2023
• Results First Posted: January 25, 2023

Record last verified: 2023-01

Locations

US (1)