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

Hernia Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01083472
• Other study ID #: LFC2009.01.01
• Status: Terminated
• Phase: Phase 4
• First received: March 8, 2010
• Last updated: September 18, 2013
• Start date: March 2010
• Est. completion date: June 2012

Study information

• Verified date: September 2013
• Source: LifeCell
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Surgical Wound Dehiscence

Intervention

Device:
• Strattice(TM) Reconstructive Tissue Matrix
Strattice(TM) TM will be used to support the repair of abdominal wall defect

Procedure:
• Suture/suture with absorbable mesh
Abdominal wall defect will be repaired with suture alone or absorbable mesh with suture

Locations

Country	Name	City	State
France	CHU Amiens Hopital Nord	Amiens
France	Hopital de la Pitie-Salpetriere	Paris
France	CHU Robert Debre	Reims
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	Kliniken der Stadt Köln	Köln
Germany	Klinikum Konstanz	Konstanz
Germany	LMU Klinikum der Universität München	München
Germany	Technischen Universität München - Klinikum rechts der Isar	München
Germany	Lukaskrankenhaus	Neuss
Germany	Klinikum St Elisabeth Straubing GmbH	Straubing
Italy	St Orsola-Malpighi University Hospital	Bologna
Netherlands	Haga Ziekenhuis	Den Haag
Netherlands	Academisch Ziekenhuis Maastrict	Maastricht
Netherlands	Erasmus Medisch Centrum	Rotterdam
Spain	Hospital Universitari del Mar	Barcelona
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

Sponsors (1)

Lead Sponsor	Collaborator
LifeCell

Countries where clinical trial is conducted

France,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

References & Publications (5)

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. — View Citation

Murugappan K, Gomes F, Waxman B. Abdominal wound dehiscence - who is really at risk? ANZ J Surg 2009; 79(S1):A25

Van Geldere D. One hundred years of abdominal wound dehiscence and nothing has changed. Hernia 2000; 4:302-4.

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Month 12 after repair	Yes