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

NCT01083472 | Terminated Phase 4 Results DMC

• 1 other identifier: LFC2009.01.01
• Study Type: interventional
• Target: 37
• Locations: 6 countries
• Sites: 29

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.

Conditions

Hernia; Surgical Wound Dehiscence

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Strattice(TM) TM repair

ACTIVE COMPARATOR

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

Standard of Care repair

ACTIVE COMPARATOR

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

Interventions

Strattice(TM) Reconstructive Tissue Matrix DEVICE

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

Strattice(TM) TM repair

Suture/suture with absorbable mesh PROCEDURE

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

Standard of Care repair

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• LifeCell: lead

Study Sites (29)

CHU Amiens Hopital Nord

Amiens, France

Location

Hopital de la Pitie-Salpetriere

Paris, France

Location

CHU Robert Debre

Reims, France

Location

Universitätsklinikum Aachen

Aachen, Germany

Location

Unfallkrankenhaus Berlin

Berlin, Germany

Location

St. Josef-Hospital

Bochum, Germany

Location

Kliniken der Stadt Köln

Cologne, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Location

Klinikum und Fachbereich Medizin der Johann Wolfgang Goethe Universitat

Frankfurt am Main, Germany

Location

Universitätsklinikum Giessen und Marburg GmbH

Giessen, Germany

Location

Universitatsklinikum Hamburg-Eppendorf

Hamburg, Germany

Location

Krankenhaus Agatharied GmbH

Hausham, Germany

Location

Krankenhaus Salem der Evang. Stadtmission Heidelberg

Heidelberg, Germany

Location

Universitatsklinikum Heidelberg

Heidelberg, Germany

Location

Klinikum Konstanz

Konstanz, Germany

Location

LMU Klinikum der Universität München

München, Germany

Location

Technischen Universität München - Klinikum rechts der Isar

München, Germany

Location

Lukaskrankenhaus

Neuss, Germany

Location

Klinikum St Elisabeth Straubing GmbH

Straubing, Germany

Location

St Orsola-Malpighi University Hospital

Bologna, Italy

Location

Academisch Ziekenhuis Maastrict

Maastricht, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, Netherlands

Location

Haga Ziekenhuis

The Hague, Netherlands

Location

Hospital Universitari del Mar

Barcelona, Spain

Location

Sandwell General Hospital

Birmingham, United Kingdom

Location

Raigmore Hospital

Inverness, United Kingdom

Location

Manchester Royal Infirmary

Manchester, United Kingdom

Location

Heart of England NHS Trust

Solihull, United Kingdom

Location

Arrowe Park Hospital

Upton, Wirral, United Kingdom

Location

Related Publications (5)

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

  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.

  PMID: 15098775 BACKGROUND

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

  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.

  PMID: 10574104 BACKGROUND

• 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.

  PMID: 12643854 BACKGROUND

MeSH Terms

Conditions

Hernia; Surgical Wound Dehiscence; Surgical Wound

Interventions

Sutures

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Sandra VanGuldener
• Organization: LifeCell

svanguldener@lifecell.com

310612504695

Study Officials

• Angus JM Watson

  Raigmore Hospital, Inverness Scotland, National Health Service, UK

  PRINCIPAL INVESTIGATOR

• Berndt Reith

  Klinikum Konstanz, Konstanz Germany

  PRINCIPAL INVESTIGATOR

• Johannes Jeekel

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 9, 2010
• Study Start: March 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 19, 2013
• Results First Posted: November 19, 2013

Record last verified: 2013-09

Locations

IT (1); FR (3); GB (5); NL (3); ES (1); DE (16)