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

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ClinicalTrials.gov Identifier: NCT01083472
Recruitment Status : Terminated (Surgical practice evolution changed acceptable standard of care and lead to potential enrollment bias.)
First Posted : March 9, 2010
Results First Posted : November 19, 2013
Last Update Posted : November 19, 2013
Information provided by (Responsible Party):

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.

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

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  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : March 2010
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Hernia Occurrence [ Time Frame: Month 12 after repair ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01083472

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
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
LMU Klinikum der Universität München
München, Germany
Technischen Universität München - Klinikum rechts der Isar
München, Germany
Neuss, Germany
Klinikum St Elisabeth Straubing GmbH
Straubing, Germany
St Orsola-Malpighi University Hospital
Bologna, Italy
Haga Ziekenhuis
Den Haag, Netherlands
Academisch Ziekenhuis Maastrict
Maastricht, Netherlands
Erasmus Medisch Centrum
Rotterdam, Netherlands
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
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

Responsible Party: LifeCell
ClinicalTrials.gov Identifier: NCT01083472     History of Changes
Other Study ID Numbers: LFC2009.01.01
First Posted: March 9, 2010    Key Record Dates
Results First Posted: November 19, 2013
Last Update Posted: November 19, 2013
Last Verified: September 2013

Keywords provided by LifeCell:
Hernia repair
surgical wound
surgical mesh

Additional relevant MeSH terms:
Surgical Wound
Surgical Wound Dehiscence
Pathological Conditions, Anatomical
Wounds and Injuries
Postoperative Complications
Pathologic Processes