Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair (StAR) (StAR)
Primary Purpose
Hernia, Surgical Wound Dehiscence
Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Strattice(TM) Reconstructive Tissue Matrix
Suture/suture with absorbable mesh
Sponsored by
About this trial
This is an interventional treatment trial for Hernia focused on measuring dehiscence, laparotomy, Hernia repair, surgical wound, surgical mesh
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: 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
Sites / Locations
- CHU Amiens Hopital Nord
- Hopital de la Pitie-Salpetriere
- CHU Robert Debre
- Universitätsklinikum Aachen
- Unfallkrankenhaus Berlin
- St. Josef-Hospital
- Universitätsklinikum Düsseldorf
- Klinikum und Fachbereich Medizin der Johann Wolfgang Goethe Universitat
- Universitätsklinikum Giessen und Marburg GmbH
- Universitatsklinikum Hamburg-Eppendorf
- Krankenhaus Agatharied GmbH
- Krankenhaus Salem der Evang. Stadtmission Heidelberg
- Universitatsklinikum Heidelberg
- Klinikum Konstanz
- Kliniken der Stadt Köln
- LMU Klinikum der Universität München
- Technischen Universität München - Klinikum rechts der Isar
- Lukaskrankenhaus
- Klinikum St Elisabeth Straubing GmbH
- St Orsola-Malpighi University Hospital
- Haga Ziekenhuis
- Academisch Ziekenhuis Maastrict
- Erasmus Medisch Centrum
- Hospital Universitari del Mar
- Sandwell General Hospital
- Raigmore Hospital
- Manchester Royal Infirmary
- Heart of England NHS Trust
- Arrowe Park Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Strattice(TM) TM repair
Standard of Care repair
Arm Description
Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect
Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01083472
Brief Title
Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair (StAR)
Acronym
StAR
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 Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Terminated
Why Stopped
Surgical practice evolution changed acceptable standard of care and lead to potential enrollment bias.
Study Start Date
March 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LifeCell
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Surgical Wound Dehiscence
Keywords
dehiscence, laparotomy, Hernia repair, surgical wound, surgical mesh
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Strattice(TM) TM repair
Arm Type
Active Comparator
Arm Description
Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect
Arm Title
Standard of Care repair
Arm Type
Active Comparator
Arm Description
Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh
Intervention Type
Device
Intervention Name(s)
Strattice(TM) Reconstructive Tissue Matrix
Intervention Description
Strattice(TM) TM will be used to support the repair of abdominal wall defect
Intervention Type
Procedure
Intervention Name(s)
Suture/suture with absorbable mesh
Intervention Description
Abdominal wall defect will be repaired with suture alone or absorbable mesh with suture
Primary Outcome Measure Information:
Title
Hernia Occurrence
Description
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.
Time Frame
Month 12 after repair
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angus JM Watson
Organizational Affiliation
Raigmore Hospital, Inverness Scotland, National Health Service, UK
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Berndt Reith
Organizational Affiliation
Klinikum Konstanz, Konstanz Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Johannes Jeekel
Official's Role
Study Chair
Facility Information:
Facility Name
CHU Amiens Hopital Nord
City
Amiens
Country
France
Facility Name
Hopital de la Pitie-Salpetriere
City
Paris
Country
France
Facility Name
CHU Robert Debre
City
Reims
Country
France
Facility Name
Universitätsklinikum Aachen
City
Aachen
Country
Germany
Facility Name
Unfallkrankenhaus Berlin
City
Berlin
Country
Germany
Facility Name
St. Josef-Hospital
City
Bochum
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf
City
Düsseldorf
Country
Germany
Facility Name
Klinikum und Fachbereich Medizin der Johann Wolfgang Goethe Universitat
City
Frankfurt am Main
Country
Germany
Facility Name
Universitätsklinikum Giessen und Marburg GmbH
City
Giessen
Country
Germany
Facility Name
Universitatsklinikum Hamburg-Eppendorf
City
Hamburg
Country
Germany
Facility Name
Krankenhaus Agatharied GmbH
City
Hausham
Country
Germany
Facility Name
Krankenhaus Salem der Evang. Stadtmission Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Universitatsklinikum Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Klinikum Konstanz
City
Konstanz
Country
Germany
Facility Name
Kliniken der Stadt Köln
City
Köln
Country
Germany
Facility Name
LMU Klinikum der Universität München
City
München
Country
Germany
Facility Name
Technischen Universität München - Klinikum rechts der Isar
City
München
Country
Germany
Facility Name
Lukaskrankenhaus
City
Neuss
Country
Germany
Facility Name
Klinikum St Elisabeth Straubing GmbH
City
Straubing
Country
Germany
Facility Name
St Orsola-Malpighi University Hospital
City
Bologna
Country
Italy
Facility Name
Haga Ziekenhuis
City
Den Haag
Country
Netherlands
Facility Name
Academisch Ziekenhuis Maastrict
City
Maastricht
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
Country
Netherlands
Facility Name
Hospital Universitari del Mar
City
Barcelona
Country
Spain
Facility Name
Sandwell General Hospital
City
Birmingham
Country
United Kingdom
Facility Name
Raigmore Hospital
City
Inverness
Country
United Kingdom
Facility Name
Manchester Royal Infirmary
City
Manchester
Country
United Kingdom
Facility Name
Heart of England NHS Trust
City
Solihull
Country
United Kingdom
Facility Name
Arrowe Park Hospital
City
Upton, Wirral
Country
United Kingdom
12. IPD Sharing Statement
Citations:
Citation
Van Geldere D. One hundred years of abdominal wound dehiscence and nothing has changed. Hernia 2000; 4:302-4.
Results Reference
background
PubMed Identifier
15098775
Citation
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.
Results Reference
background
Citation
Murugappan K, Gomes F, Waxman B. Abdominal wound dehiscence - who is really at risk? ANZ J Surg 2009; 79(S1):A25
Results Reference
background
PubMed Identifier
10574104
Citation
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.
Results Reference
background
PubMed Identifier
12643854
Citation
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.
Results Reference
background
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Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair (StAR)
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