Repair of Significant Abdominal Midline Fascial Dehiscence: Strattice(TM) TM in Abdominal Wall Repair (StAR) - Full Text View

Sponsor:	LifeCell
Information provided by:	LifeCell
ClinicalTrials.gov Identifier:	NCT01083472

Purpose

The objective of this study is to compare the incidence of abdominal incision hernia between postoperative fascial dehiscences repaired with Strattice(TM) Reconstructive Tissue Matrix (TM) and those managed by standard repair. It is hypothesized that the use of Strattice(TM) TM will decrease the incidence of incision herniation.

Condition	Intervention	Phase
Surgical Wound Dehiscence	Device: Strattice(TM) Reconstructive Tissue Matrix Procedure: Suture/suture with absorbable mesh	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	A Multicenter, Prospective, Single-Blind, Randomized, Controlled, Study of the Repair of Significant Abdominal Midline Fascial Dehiscence: Strattice(TM) TM in Abdominal Wall Repair

Resource links provided by NLM:

MedlinePlus related topics: Hernia

U.S. FDA Resources

Further study details as provided by LifeCell:

Primary Outcome Measures:

Hernia occurrence [ Time Frame: Month 12 after repair ] [ Designated as safety issue: Yes ]
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.

Secondary Outcome Measures:

recurrence of fascial dehiscence [ Time Frame: First 30 days post-repair of initial dehiscence ] [ Designated as safety issue: Yes ]
recurrence of fascial dehiscence will be clinically evaluated

Estimated Enrollment:	200
Study Start Date:	March 2010
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Strattice(TM) TM repair: Active Comparator Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal fascial dehiscence	Device: Strattice(TM) Reconstructive Tissue Matrix Strattice(TM) TM will be used to support the repair of abdominal fascial dehiscence
Standard of Care repair: Active Comparator Fascial dehiscence 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 Fascial dehiscence will be repaired with suture alone or absorbable mesh with suture

Detailed Description:

This is a prospective, multicenter, single-blind, randomized, longitudinal evaluation of the repair of postoperative fascial dehiscence of a vertical midline incision using Strattice(TM) TM or standard surgical repair. An adaptive study design will be used to validate the initial conditional power of the study and a balanced randomization, based upon the two conditions of severity and days of open abdomen, 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 recurrence of dehiscence, incidence and severity of repair site complications, 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adults (18years of age or older)
has need of surgical intervention for repair of fascial dehiscence of 3cm or more in length, where dehiscence occurred within 30 days of laparotomy and repair of dehiscence is 10days or less from time of initial dehiscence

Exclusion Criteria: at the time of randomization

systemic sepsis
frank pus in the wound, a fistula or intra-abdominal abscess in surgical area,
ongoing necrotizing pancreatitis,
requires only temporary closure,
is unable to undergo general anesthesia,
has other major organ system dysfunction or disorder that would jeopardize subject completing the 24 month study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01083472

Contacts

Contact: Sandra van Guldener	+31-20-4260038	sguldene@kci1.com
Contact: Randi Rutan	+1-908-947-1349	rrutan@lifecell.com

Locations

Germany
Universitätsklinikum Aachen
Aachen, Germany
St. Josef-Hospital
Bochum, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Universitätsklinikum Giessen und Marburg GmbH
Giessen, Germany
Krankenhaus Agatharied GmbH
Hausham, Germany
Klinikum Konstanz
Konstanz, Germany
Kliniken der Stadt Köln
Köln, Germany
Technischen Universität München - Klinikum rechts der Isar
München, Germany
LMU Klinikum der Universität München
München, Germany
Lukaskrankenhaus
Neuss, Germany
United Kingdom
Sandwell General Hospital
Birmingham, United Kingdom
Raigmore Hospital
Inverness, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom
Heart of England NHS Trust
Solihull, United Kingdom
Arrowe Park Hospital
Upton, Wirral, United Kingdom

Sponsors and Collaborators

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

More Information

Publications:

Van Geldere D. One hundred years of abdominal wound dehiscence and nothing has changed. Hernia 2000; 4:302-4.

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.

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.

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.

Responsible Party:	LifeCell Corporation ( Janice M. Smiell, MD; Vice President Medical Affairs )
ClinicalTrials.gov Identifier:	NCT01083472 History of Changes
Other Study ID Numbers:	LFC2009.01.01
Study First Received:	March 8, 2010
Last Updated:	March 8, 2010
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: National Health Service

Keywords provided by LifeCell:

dehiscence
laparotomy
surgical wound
surgical mesh

Additional relevant MeSH terms:

Surgical Wound Dehiscence
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on September 01, 2010