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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
Sponsor:
Information provided by (Responsible Party):
LifeCell

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.

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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
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

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, Older Adult)
Sexes Eligible for Study:   All
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

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


Locations
Show Show 29 study locations
Sponsors and Collaborators
LifeCell
Investigators
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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

Publications:
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Responsible Party: LifeCell
ClinicalTrials.gov Identifier: NCT01083472    
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:
dehiscence
laparotomy
Hernia repair
surgical wound
surgical mesh
Additional relevant MeSH terms:
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Hernia
Surgical Wound Dehiscence
Surgical Wound
Pathological Conditions, Anatomical
Wounds and Injuries
Postoperative Complications
Pathologic Processes