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

NCT ID: NCT01083472

Last Updated: 2013-11-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-06-30

Brief Summary

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.

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.

Conditions

Hernia; Surgical Wound Dehiscence

Keywords

dehiscence; laparotomy; Hernia repair; surgical wound; surgical mesh

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Strattice(TM) TM repair

Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect

Group Type: ACTIVE_COMPARATOR

Strattice(TM) Reconstructive Tissue Matrix

Intervention Type: DEVICE

Strattice(TM) TM will be used to support the repair of abdominal wall defect

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

Group Type: ACTIVE_COMPARATOR

Suture/suture with absorbable mesh

Intervention Type: PROCEDURE

Abdominal wall defect will be repaired with suture alone or absorbable mesh with suture

Interventions

Strattice(TM) Reconstructive Tissue Matrix

Strattice(TM) TM will be used to support the repair of abdominal wall defect

Intervention Type: DEVICE

Suture/suture with absorbable mesh

Abdominal wall defect will be repaired with suture alone or absorbable mesh with suture

Intervention Type: PROCEDURE

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LifeCell

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angus JM Watson

Role: PRINCIPAL_INVESTIGATOR

Raigmore Hospital, Inverness Scotland, National Health Service, UK

Berndt Reith

Role: PRINCIPAL_INVESTIGATOR

Klinikum Konstanz, Konstanz Germany

Johannes Jeekel

Role: STUDY_CHAIR

Locations

CHU Amiens Hopital Nord

Amiens, , France

Hopital de la Pitie-Salpetriere

Paris, , France

CHU Robert Debre

Reims, , France

Universitätsklinikum Aachen

Aachen, , Germany

Unfallkrankenhaus Berlin

Berlin, , Germany

St. Josef-Hospital

Bochum, , Germany

Kliniken der Stadt Köln

Cologne, , Germany

Universitätsklinikum Düsseldorf

Düsseldorf, , Germany

Klinikum und Fachbereich Medizin der Johann Wolfgang Goethe Universitat

Frankfurt am Main, , Germany

Universitätsklinikum Giessen und Marburg GmbH

Giessen, , Germany

Universitatsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Krankenhaus Agatharied GmbH

Hausham, , Germany

Krankenhaus Salem der Evang. Stadtmission Heidelberg

Heidelberg, , Germany

Universitatsklinikum Heidelberg

Heidelberg, , Germany

Klinikum Konstanz

Konstanz, , Germany

LMU Klinikum der Universität München

München, , Germany

Technischen Universität München - Klinikum rechts der Isar

München, , Germany

Lukaskrankenhaus

Neuss, , Germany

Klinikum St Elisabeth Straubing GmbH

Straubing, , Germany

St Orsola-Malpighi University Hospital

Bologna, , Italy

Academisch Ziekenhuis Maastrict

Maastricht, , Netherlands

Erasmus Medisch Centrum

Rotterdam, , Netherlands

Haga Ziekenhuis

The Hague, , Netherlands

Hospital Universitari del Mar

Barcelona, , Spain

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

Countries

Austria; France; Germany; Italy; Netherlands; Spain; United Kingdom

References

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 15098775 (View on PubMed)

Murugappan K, Gomes F, Waxman B. Abdominal wound dehiscence - who is really at risk? ANZ J Surg 2009; 79(S1):A25

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 10574104 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12643854 (View on PubMed)

Other Identifiers

LFC2009.01.01

Identifier Type: -

Identifier Source: org_study_id