Trial Outcomes & Findings for Hernia Repair in Multiply Morbid Patients (NCT NCT00930787)
NCT ID: NCT00930787
Last Updated: 2013-11-20
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
23 participants
Primary outcome timeframe
Postoperative Day 30
Results posted on
2013-11-20
Participant Flow
23 subjects recruited from 9 US sites between August 2009 and May 2010.
Participant milestones
| Measure |
Strattice Reconstructive Tissue Matrix
Use of Strattice Reconstructive Tissue Matrix to support hernia repair
|
Proceed Surgical Mesh
Use of Proceed Surgical Mesh to support hernia repair
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
9
|
|
Overall Study
COMPLETED
|
14
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hernia Repair in Multiply Morbid Patients
Baseline characteristics by cohort
| Measure |
Strattice Reconstructive Tissue Matrix
n=14 Participants
Use of Strattice Reconstructive Tissue Matrix to support hernia repair
|
Proceed Surgical Mesh
n=9 Participants
Use of Proceed Surgical Mesh to support hernia repair
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
58.2 years
STANDARD_DEVIATION 11.47 • n=5 Participants
|
52.7 years
STANDARD_DEVIATION 13.54 • n=7 Participants
|
56 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Postoperative Day 30Population: Study was terminated early and no analyses were conducted.
Outcome measures
Outcome data not reported
Adverse Events
Strattice Reconstructive Tissue Matrix
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Proceed Surgical Mesh
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Strattice Reconstructive Tissue Matrix
n=14 participants at risk
Use of Strattice Reconstructive Tissue Matrix to support hernia repair
|
Proceed Surgical Mesh
n=9 participants at risk
Use of Proceed Surgical Mesh to support hernia repair
|
|---|---|---|
|
Infections and infestations
Wound Infection
|
0.00%
0/14
|
11.1%
1/9 • Number of events 1
|
Other adverse events
| Measure |
Strattice Reconstructive Tissue Matrix
n=14 participants at risk
Use of Strattice Reconstructive Tissue Matrix to support hernia repair
|
Proceed Surgical Mesh
n=9 participants at risk
Use of Proceed Surgical Mesh to support hernia repair
|
|---|---|---|
|
Surgical and medical procedures
Incisional drainage
|
0.00%
0/14
|
11.1%
1/9 • Number of events 1
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
28.6%
4/14 • Number of events 5
|
11.1%
1/9 • Number of events 5
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/14
|
22.2%
2/9 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/14
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Localised intraabdominal fluid
|
0.00%
0/14
|
11.1%
1/9 • Number of events 1
|
|
Injury, poisoning and procedural complications
Seroma
|
21.4%
3/14 • Number of events 5
|
22.2%
2/9 • Number of events 5
|
|
Investigations
International normalised ratio increased
|
0.00%
0/14
|
11.1%
1/9 • Number of events 1
|
|
Investigations
Urine output decreased
|
28.6%
4/14 • Number of events 4
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/14
|
11.1%
1/9 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/14
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
35.7%
5/14 • Number of events 6
|
11.1%
1/9 • Number of events 6
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/14
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
2/14 • Number of events 3
|
11.1%
1/9 • Number of events 3
|
|
General disorders
Pyrexia
|
35.7%
5/14 • Number of events 5
|
0.00%
0/9
|
|
Infections and infestations
Incision site infection
|
0.00%
0/14
|
11.1%
1/9 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place