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

This study has been terminated.
(Surgical practice evolution changed acceptable standard of care and lead to potential enrollment bias.)
Sponsor:
Information provided by (Responsible Party):
LifeCell
ClinicalTrials.gov Identifier:
NCT01083472
First received: March 8, 2010
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Hernia
Surgical Wound Dehiscence
Device: Strattice(TM) Reconstructive Tissue Matrix
Procedure: Suture/suture with absorbable mesh
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
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 Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair

Resource links provided by NLM:


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.


Enrollment: 37
Study Start Date: March 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  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) 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
CHU Amiens Hopital Nord
Amiens, France
Hopital de la Pitie-Salpetriere
Paris, France
CHU Robert Debre
Reims, France
Germany
Universitätsklinikum Aachen
Aachen, Germany
Unfallkrankenhaus Berlin
Berlin, Germany
St. Josef-Hospital
Bochum, 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
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
Klinikum St Elisabeth Straubing GmbH
Straubing, Germany
Italy
St Orsola-Malpighi University Hospital
Bologna, Italy
Netherlands
Haga Ziekenhuis
Den Haag, Netherlands
Academisch Ziekenhuis Maastrict
Maastricht, Netherlands
Erasmus Medisch Centrum
Rotterdam, Netherlands
Spain
Hospital Universitari del Mar
Barcelona, Spain
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:
Responsible Party: LifeCell
ClinicalTrials.gov Identifier: NCT01083472     History of Changes
Other Study ID Numbers: LFC2009.01.01
Study First Received: March 8, 2010
Results First Received: September 18, 2013
Last Updated: September 18, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: National Health Service

Keywords provided by LifeCell:
dehiscence
laparotomy
Hernia repair
surgical wound
surgical mesh

Additional relevant MeSH terms:
Surgical Wound Dehiscence
Pathologic Processes
Postoperative Complications

ClinicalTrials.gov processed this record on October 23, 2014