Trial Outcomes & Findings for Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair (StAR) (NCT NCT01083472)
NCT ID: NCT01083472
Last Updated: 2013-11-19
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
37 participants
Primary outcome timeframe
Month 12 after repair
Results posted on
2013-11-19
Participant Flow
Participant milestones
| Measure |
Strattice(TM) TM Repair
Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
19
|
|
Overall Study
COMPLETED
|
18
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Repair of Challenging Abdominal Wall Defects: Strattice(TM) TM in Abdominal Wall Repair (StAR)
Baseline characteristics by cohort
| Measure |
Strattice(TM) TM Repair
n=18 Participants
Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect
|
Standard of Care Repair
n=19 Participants
Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
70 years
STANDARD_DEVIATION 9.94 • n=5 Participants
|
67 years
STANDARD_DEVIATION 8.49 • n=7 Participants
|
68.5 years
STANDARD_DEVIATION 9.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 12 after repairPopulation: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Strattice(TM) TM Repair
Serious events: 7 serious events
Other events: 16 other events
Deaths: 0 deaths
Standard of Care Repair
Serious events: 8 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Strattice(TM) TM Repair
n=18 participants at risk
Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect
|
Standard of Care Repair
n=19 participants at risk
Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh
|
|---|---|---|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/18
|
5.3%
1/19 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
1/18 • Number of events 1
|
0.00%
0/19
|
|
Gastrointestinal disorders
Pyrexia
|
5.6%
1/18 • Number of events 2
|
0.00%
0/19
|
|
Infections and infestations
Bacterial Sepsis
|
5.6%
1/18 • Number of events 1
|
0.00%
0/19
|
|
Infections and infestations
Infectious Peritonitis
|
0.00%
0/18
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Post Operative Wound Infection
|
5.6%
1/18 • Number of events 1
|
0.00%
0/19
|
|
Infections and infestations
Sepsis
|
0.00%
0/18
|
5.3%
1/19 • Number of events 1
|
|
Infections and infestations
Wound Infection
|
16.7%
3/18 • Number of events 3
|
5.3%
1/19 • Number of events 1
|
|
Injury, poisoning and procedural complications
Incisional Hernia
|
0.00%
0/18
|
5.3%
1/19 • Number of events 1
|
|
Injury, poisoning and procedural complications
Seroma
|
5.6%
1/18 • Number of events 1
|
0.00%
0/19
|
|
Infections and infestations
Wound Dehiscence
|
16.7%
3/18 • Number of events 3
|
36.8%
7/19 • Number of events 8
|
|
Injury, poisoning and procedural complications
Wound Necrosis
|
11.1%
2/18 • Number of events 2
|
5.3%
1/19 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound Secretion
|
0.00%
0/18
|
5.3%
1/19 • Number of events 1
|
|
Reproductive system and breast disorders
Female Genital Tract Fistula
|
5.6%
1/18 • Number of events 1
|
0.00%
0/19
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/18
|
5.3%
1/19 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
5.6%
1/18 • Number of events 1
|
0.00%
0/19
|
|
Vascular disorders
Circulatory Collapse
|
0.00%
0/18
|
5.3%
1/19 • Number of events 1
|
Other adverse events
| Measure |
Strattice(TM) TM Repair
n=18 participants at risk
Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect
|
Standard of Care Repair
n=19 participants at risk
Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood and Lymphatic System Disorders
|
0.00%
0/18
|
15.8%
3/19 • Number of events 3
|
|
Cardiac disorders
Cardiac Disorders
|
5.6%
1/18 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
|
Endocrine disorders
Endocrine Disorders
|
5.6%
1/18 • Number of events 1
|
0.00%
0/19
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
27.8%
5/18 • Number of events 5
|
36.8%
7/19 • Number of events 7
|
|
General disorders
General Disorders Administration Site Conditions
|
16.7%
3/18 • Number of events 3
|
21.1%
4/19 • Number of events 4
|
|
Infections and infestations
Infections and Infestations
|
61.1%
11/18 • Number of events 11
|
47.4%
9/19 • Number of events 9
|
|
Injury, poisoning and procedural complications
Injury, Poisoning and Procedural Complications
|
50.0%
9/18 • Number of events 9
|
63.2%
12/19 • Number of events 12
|
|
Metabolism and nutrition disorders
Metabolism and Nutrition Disorders
|
11.1%
2/18 • Number of events 2
|
5.3%
1/19 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorders
|
5.6%
1/18 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
|
Nervous system disorders
Nervous System Disorders
|
11.1%
2/18 • Number of events 2
|
0.00%
0/19
|
|
Renal and urinary disorders
Renal and Urinary Disorders
|
5.6%
1/18 • Number of events 1
|
5.3%
1/19 • Number of events 1
|
|
Reproductive system and breast disorders
Reproductive System and Breast Disorders
|
5.6%
1/18 • Number of events 1
|
0.00%
0/19
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic and Mediastinal Disorders
|
11.1%
2/18 • Number of events 2
|
21.1%
4/19 • Number of events 4
|
|
Surgical and medical procedures
Surgical and Medical Procedures
|
5.6%
1/18 • Number of events 1
|
0.00%
0/19
|
|
Vascular disorders
Vascular Disorders
|
5.6%
1/18 • Number of events 1
|
10.5%
2/19 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER