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

• Sponsor: LifeCell (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01083472
• Collaborator: (none)
• Enrollment: 37
• Locations: 29
• Arms: 2
• Duration (Months): 27
• Patients Per Site: 1.3
• Patients Per Site Per Month: 0

Study Details

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.

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 Design

• Study Type: Interventional
• 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: Mar 1, 2010
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Hernia Occurrence [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens Hopital Nord	Amiens		France
2	Hopital de la Pitie-Salpetriere	Paris		France
3	CHU Robert Debre	Reims		France
4	Universitätsklinikum Aachen	Aachen		Germany
5	Unfallkrankenhaus Berlin	Berlin		Germany
6	St. Josef-Hospital	Bochum		Germany
7	Universitätsklinikum Düsseldorf	Düsseldorf		Germany
8	Klinikum und Fachbereich Medizin der Johann Wolfgang Goethe Universitat	Frankfurt am Main		Germany
9	Universitätsklinikum Giessen und Marburg GmbH	Giessen		Germany
10	Universitatsklinikum Hamburg-Eppendorf	Hamburg		Germany
11	Krankenhaus Agatharied GmbH	Hausham		Germany
12	Krankenhaus Salem der Evang. Stadtmission Heidelberg	Heidelberg		Germany
13	Universitatsklinikum Heidelberg	Heidelberg		Germany
14	Klinikum Konstanz	Konstanz		Germany
15	Kliniken der Stadt Köln	Köln		Germany
16	LMU Klinikum der Universität München	München		Germany
17	Technischen Universität München - Klinikum rechts der Isar	München		Germany
18	Lukaskrankenhaus	Neuss		Germany
19	Klinikum St Elisabeth Straubing GmbH	Straubing		Germany
20	St Orsola-Malpighi University Hospital	Bologna		Italy
21	Haga Ziekenhuis	Den Haag		Netherlands
22	Academisch Ziekenhuis Maastrict	Maastricht		Netherlands
23	Erasmus Medisch Centrum	Rotterdam		Netherlands
24	Hospital Universitari del Mar	Barcelona		Spain
25	Sandwell General Hospital	Birmingham		United Kingdom
26	Raigmore Hospital	Inverness		United Kingdom
27	Manchester Royal Infirmary	Manchester		United Kingdom
28	Heart of England NHS Trust	Solihull		United Kingdom
29	Arrowe Park Hospital	Upton, Wirral		United Kingdom

Sponsors and Collaborators

• LifeCell

Investigators

• 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,

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: LifeCell
• ClinicalTrials.gov Identifier: NCT01083472
• Other Study ID Numbers: LFC2009.01.01
• First Posted: Mar 9, 2010
• Last Update Posted: Nov 19, 2013
• Last Verified: Sep 1, 2013

• Keywords provided by LifeCell: dehiscence; laparotomy; Hernia repair; surgical wound; surgical mesh
• Additional relevant MeSH terms: Hernia; Surgical Wound Dehiscence; Surgical Wound

Study Results

Participant Flow

Arm/Group Title	Strattice(TM) TM Repair	Standard of Care Repair
Arm/Group 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
Period Title: Overall Study
STARTED	18	19
COMPLETED	18	19
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Strattice(TM) TM Repair	Standard of Care Repair	Total
Arm/Group 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	Total of all reporting groups
Overall Participants	18	19	37
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70 (9.94)	67 (8.49)	68.5 (9.22)
Sex: Female, Male (Count of Participants)
Female	6 33.3%	6 31.6%	12 32.4%
Male	12 66.7%	13 68.4%	25 67.6%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Due to early termination of the study and the low enrollment number (only 37 subjects out of the planned 200 subjects being enrolled), all planned analyses of study endpoints were not performed. The only study results obtained focused on safety. Due to the small sample size these safety results should be interpreted with caution.

Arm/Group Title	Strattice(TM) TM Repair	Standard of Care Repair
Arm/Group 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
Measure Participants	0	0

Adverse Events

Arm/Group Title	Strattice(TM) TM Repair		Standard of Care Repair
Arm/Group 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
All Cause Mortality
	Strattice(TM) TM Repair		Standard of Care Repair
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Strattice(TM) TM Repair		Standard of Care Repair
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/18 (38.9%)		8/19 (42.1%)
Gastrointestinal disorders
Ileus	0/18 (0%)	0	1/19 (5.3%)	1
Diarrhea	1/18 (5.6%)	1	0/19 (0%)	0
Pyrexia	1/18 (5.6%)	2	0/19 (0%)	0
Infections and infestations
Bacterial Sepsis	1/18 (5.6%)	1	0/19 (0%)	0
Infectious Peritonitis	0/18 (0%)	0	1/19 (5.3%)	1
Post Operative Wound Infection	1/18 (5.6%)	1	0/19 (0%)	0
Sepsis	0/18 (0%)	0	1/19 (5.3%)	1
Wound Infection	3/18 (16.7%)	3	1/19 (5.3%)	1
Wound Dehiscence	3/18 (16.7%)	3	7/19 (36.8%)	8
Injury, poisoning and procedural complications
Incisional Hernia	0/18 (0%)	0	1/19 (5.3%)	1
Seroma	1/18 (5.6%)	1	0/19 (0%)	0
Wound Necrosis	2/18 (11.1%)	2	1/19 (5.3%)	1
Wound Secretion	0/18 (0%)	0	1/19 (5.3%)	1
Reproductive system and breast disorders
Female Genital Tract Fistula	1/18 (5.6%)	1	0/19 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pleural Effusion	0/18 (0%)	0	1/19 (5.3%)	2
Pulmonary Embolism	1/18 (5.6%)	1	0/19 (0%)	0
Vascular disorders
Circulatory Collapse	0/18 (0%)	0	1/19 (5.3%)	1
Other (Not Including Serious) Adverse Events
	Strattice(TM) TM Repair		Standard of Care Repair
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/18 (88.9%)		15/19 (78.9%)
Blood and lymphatic system disorders
Blood and Lymphatic System Disorders	0/18 (0%)	0	3/19 (15.8%)	3
Cardiac disorders
Cardiac Disorders	1/18 (5.6%)	1	1/19 (5.3%)	1
Endocrine disorders
Endocrine Disorders	1/18 (5.6%)	1	0/19 (0%)	0
Gastrointestinal disorders
Gastrointestinal Disorders	5/18 (27.8%)	5	7/19 (36.8%)	7
General disorders
General Disorders Administration Site Conditions	3/18 (16.7%)	3	4/19 (21.1%)	4
Infections and infestations
Infections and Infestations	11/18 (61.1%)	11	9/19 (47.4%)	9
Injury, poisoning and procedural complications
Injury, Poisoning and Procedural Complications	9/18 (50%)	9	12/19 (63.2%)	12
Metabolism and nutrition disorders
Metabolism and Nutrition Disorders	2/18 (11.1%)	2	1/19 (5.3%)	1
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorders	1/18 (5.6%)	1	1/19 (5.3%)	1
Nervous system disorders
Nervous System Disorders	2/18 (11.1%)	2	0/19 (0%)	0
Renal and urinary disorders
Renal and Urinary Disorders	1/18 (5.6%)	1	1/19 (5.3%)	1
Reproductive system and breast disorders
Reproductive System and Breast Disorders	1/18 (5.6%)	1	0/19 (0%)	0
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic and Mediastinal Disorders	2/18 (11.1%)	2	4/19 (21.1%)	4
Surgical and medical procedures
Surgical and Medical Procedures	1/18 (5.6%)	1	0/19 (0%)	0
Vascular disorders
Vascular Disorders	1/18 (5.6%)	1	2/19 (10.5%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.