Clinical trial NCT01083472: Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair (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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hernia
Surgical Wound Dehiscence
Keywords: dehiscence
laparotomy
Hernia repair
surgical wound
surgical mesh
Lead sponsor: LifeCell
Sponsor class: INDUSTRY
First posted: 2010-03-09
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hernia Occurrence
timeFrame: Month 12 after repair
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Hopital Nord
city: Paris
country: France
facility: Hopital de la Pitie-Salpetriere
city: Reims
country: France
facility: CHU Robert Debre
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
city: Berlin
country: Germany
facility: Unfallkrankenhaus Berlin
city: Bochum
country: Germany
facility: St. Josef-Hospital
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Frankfurt am Main
country: Germany
facility: Klinikum und Fachbereich Medizin der Johann Wolfgang Goethe Universitat
city: Giessen
country: Germany
facility: Universitätsklinikum Giessen und Marburg GmbH
city: Hamburg
country: Germany
facility: Universitatsklinikum Hamburg-Eppendorf
city: Hausham
country: Germany
facility: Krankenhaus Agatharied GmbH
city: Heidelberg
country: Germany
facility: Krankenhaus Salem der Evang. Stadtmission Heidelberg
city: Heidelberg
country: Germany
facility: Universitatsklinikum Heidelberg
city: Konstanz
country: Germany
facility: Klinikum Konstanz
city: Köln
country: Germany
facility: Kliniken der Stadt Köln
city: München
country: Germany
facility: LMU Klinikum der Universität München
city: München
country: Germany
facility: Technischen Universität München - Klinikum rechts der Isar
city: Neuss
country: Germany
facility: Lukaskrankenhaus
city: Straubing
country: Germany
facility: Klinikum St Elisabeth Straubing GmbH
city: Bologna
country: Italy
facility: St Orsola-Malpighi University Hospital
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastrict
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Barcelona
country: Spain
facility: Hospital Universitari del Mar
city: Birmingham
country: United Kingdom
facility: Sandwell General Hospital
city: Inverness
country: United Kingdom
facility: Raigmore Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Solihull
country: United Kingdom
facility: Heart of England NHS Trust
city: Upton, Wirral
country: United Kingdom
facility: Arrowe Park Hospital
Study officials:
affiliation: Raigmore Hospital, Inverness Scotland, National Health Service, UK
name: Angus JM Watson
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum Konstanz, Konstanz Germany
name: Berndt Reith
role: PRINCIPAL_INVESTIGATOR
name: Johannes Jeekel
role: STUDY_CHAIR
References:
citation: Van Geldere D. One hundred years of abdominal wound dehiscence and nothing has changed. Hernia 2000; 4:302-4.
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.
citation: Murugappan K, Gomes F, Waxman B. Abdominal wound dehiscence - who is really at risk? ANZ J Surg 2009; 79(S1):A25
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.
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.