Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair (StAR) (StAR)

A Multicenter, Prospective, Single-Blind, Randomized, Controlled Study of the Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair

The objective of this study is to compare the incidence of post-repair wound related complications, including hernia occurrence/recurrence, between challenging abdominal wall defects repaired with Strattice(TM) Reconstructive Tissue Matrix (TM) and those managed by standard repair. It is hypothesized that the use of Strattice(TM) TM to reinforce the repair will reduce the incidence of these post-repair complications.

Study Overview

• Status: Terminated
• Conditions: Hernia; Surgical Wound Dehiscence
• Intervention / Treatment: Device: Strattice(TM) Reconstructive Tissue Matrix; Procedure: Suture/suture with absorbable mesh

Detailed Description

This is a prospective, multicenter, single-blind, randomized, longitudinal, cross-over evaluation of the repair of challenging abdominal wall defects using Strattice(TM) TM or standard surgical repair. These abdominal wall defects can be acute or chronic, and include midline, transverse (including flank) as well as Pfannenstiel incisions. The skin may be closed (fascial dehiscence or incisional hernia) or open (patient with open abdomen or acute fascial dehiscence) with or without evisceration. Patients randomized to the control group who require a re-operation to perform the planned final repair or due to failure of the initial repair within 12 months, will be offered repair with Strattice™ TM (i.e. "crossed over") or if such repair not performed, the patient will have completed the study. An adaptive study design will be used to validate the initial conditional power of the study and a balanced randomization, based upon the three conditions (type of defect [dehiscence, hernia repair or open abdomen], morbidity [POSSUM score] and time since exposure of abdominal fascia/viscera) will be used to equally distribute subjects between groups.

The primary endpoint of this study is hernia occurrence at 12 months post repair and secondary endpoints include re-operation for abdominal wall repair within 12 months, incidence of complications requiring intervention(medical or surgical) within the first 30 days after repair,, length of hospitalization and resource utilization, and all cause mortality.

Subjects will be enrolled and randomized to receive Strattice(TM) TM reinforcement of repair or standard of care repair (i.e. suture alone or suture with absorbable mesh) and followed at set timepoints to observe incision site repair for surgical site events, including reoperation and hernia occurrence.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Amiens, France
    • CHU Amiens Hopital Nord
  • Paris, France
    • Hôpital de la Pitié-Salpêtrière
  • Reims, France
    • CHU Robert Debré
• Germany
  • Aachen, Germany
    • Universitätsklinikum Aachen
  • Berlin, Germany
    • Unfallkrankenhaus Berlin
  • Bochum, Germany
    • St. Josef-Hospital
  • Düsseldorf, Germany
    • Universitatsklinikum Dusseldorf
  • Frankfurt am Main, Germany
    • Klinikum und Fachbereich Medizin der Johann Wolfgang Goethe Universitat
  • Giessen, Germany
    • Universitätsklinikum Giessen und Marburg GmbH
  • Hamburg, Germany
    • Universitätsklinikum Hamburg-Eppendorf
  • Hausham, Germany
    • Krankenhaus Agatharied GmbH
  • Heidelberg, Germany
    • Universitätsklinikum Heidelberg
  • Heidelberg, Germany
    • Krankenhaus Salem der Evang. Stadtmission Heidelberg
  • Konstanz, Germany
    • Klinikum Konstanz
  • Köln, Germany
    • Kliniken der Stadt Koln
  • München, Germany
    • LMU Klinikum der Universität München
  • München, Germany
    • Technischen Universität München - Klinikum rechts der Isar
  • Neuss, Germany
    • Lukaskrankenhaus
  • Straubing, Germany
    • Klinikum St Elisabeth Straubing GmbH
• Italy
  • Bologna, Italy
    • St Orsola-Malpighi University Hospital
• Netherlands
  • Den Haag, Netherlands
    • Haga ziekenhuis
  • Maastricht, Netherlands
    • Academisch Ziekenhuis Maastrict
  • Rotterdam, Netherlands
    • Erasmus Medisch Centrum
• Spain
  • Barcelona, Spain
    • Hospital Universitari del Mar
• United Kingdom
  • Birmingham, United Kingdom
    • Sandwell General Hospital
  • Inverness, United Kingdom
    • Raigmore Hospital
  • Manchester, United Kingdom
    • Manchester Royal Infirmary
  • Solihull, United Kingdom
    • Heart of England NHS Trust
  • Upton, Wirral, United Kingdom
    • Arrowe Park Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adults (18years of age or older) who is able to provide written informed consent for study participation
• has need of surgical intervention for repair of (potentially) contaminated abdominal wall defect of >3cm and <22cm in length, where the viscera have not been exposed for more than 15 days in case of open abdomen(skin and fascia open).
• Is willing and able to return for all scheduled & required study visit.

Exclusion Criteria: at the time of randomization

• severe systemic sepsis
• frank pus in the wound, a fistula that will not be closed at the time of surgery or intra-abdominal abscess in surgical area,
• ongoing necrotizing pancreatitis,
• Is on chronic immunosuppressive therapy, or other medication that influences wound healing
• requires only short-term temporary closure,
• requires a synthetic, non-absorbable mesh to close the abdominal wall defect
• is unable to undergo general anesthesia,
• has other major organ system dysfunction or disorder that would jeopardize subject completing the 24 month study.
• Is unable to undergo an MRI scan

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Strattice(TM) TM repair; Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect	Device: Strattice(TM) Reconstructive Tissue Matrix; Strattice(TM) TM will be used to support the repair of abdominal wall defect
Active Comparator: Standard of Care repair; Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh	Procedure: Suture/suture with absorbable mesh; Abdominal wall defect will be repaired with suture alone or absorbable mesh with suture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hernia Occurrence	Hernia occurrence will be assessed by clinical evaluation. At Month 12 and at any time during the study if hernia occurrence is clinically suspected, a magnetic resonance image (MRI) will be obtained.	Month 12 after repair

Collaborators and Investigators

• Sponsor: LifeCell
• Investigators: Principal Investigator: Angus JM Watson, Raigmore Hospital, Inverness Scotland, National Health Service, UK; Principal Investigator: Berndt Reith, Klinikum Konstanz, Konstanz Germany; Study Chair: Johannes Jeekel

Publications and helpful links

General Publications

• van't RM, De Vos Van Steenwijk PJ, Bonjer HJ, Steyerberg EW, Jeekel J. Incisional hernia after repair of wound dehiscence: incidence and risk factors. Am Surg. 2004 Apr;70(4):281-6.
• Webster C, Neumayer L, Smout R, Horn S, Daley J, Henderson W, Khuri S; National Veterans Affairs Surgical Quality Improvement Program. Prognostic models of abdominal wound dehiscence after laparotomy. J Surg Res. 2003 Feb;109(2):130-7. doi: 10.1016/s0022-4804(02)00097-5.
• Van Geldere D. One hundred years of abdominal wound dehiscence and nothing has changed. Hernia 2000; 4:302-4.
• Murugappan K, Gomes F, Waxman B. Abdominal wound dehiscence - who is really at risk? ANZ J Surg 2009; 79(S1):A25
• Gislason H, Viste A. Closure of burst abdomen after major gastrointestinal operations--comparison of different surgical techniques and later development of incisional hernia. Eur J Surg. 1999 Oct;165(10):958-61. doi: 10.1080/110241599750008071.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: March 8, 2010
• First Submitted That Met QC Criteria: March 8, 2010
• First Posted (Estimate): March 9, 2010

Study Record Updates

• Last Update Posted (Estimate): November 19, 2013
• Last Update Submitted That Met QC Criteria: September 18, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: laparotomy; surgical mesh; Hernia repair; surgical wound; dehiscence
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Wounds and Injuries; Pathological Conditions, Anatomical; Hernia; Surgical Wound; Surgical Wound Dehiscence
• Other Study ID Numbers: LFC2009.01.01