Trial Outcomes & Findings for Evaluation of Surgisis Gold Graft for Incision Reinforcement After Open Bariatric Surgery (NCT NCT00274625)
NCT ID: NCT00274625
Last Updated: 2014-11-12
Results Overview
An obvious defect or interruption of the fascia in the area of the incision that was palpable on clinical examination and/or visible by a cross-sectional imaging modality.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
402 participants
Primary outcome timeframe
2 years
Results posted on
2014-11-12
Participant Flow
Participant milestones
| Measure |
Surgisis Gold
Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
|
Suture Closure
Control : Incision is closed without the placement of a graft material (standard of care control)
|
|---|---|---|
|
Overall Study
STARTED
|
199
|
203
|
|
Overall Study
COMPLETED
|
139
|
141
|
|
Overall Study
NOT COMPLETED
|
60
|
62
|
Reasons for withdrawal
| Measure |
Surgisis Gold
Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
|
Suture Closure
Control : Incision is closed without the placement of a graft material (standard of care control)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
46
|
54
|
|
Overall Study
Excluded from analysis
|
14
|
8
|
Baseline Characteristics
Evaluation of Surgisis Gold Graft for Incision Reinforcement After Open Bariatric Surgery
Baseline characteristics by cohort
| Measure |
Surgisis Gold
n=185 Participants
Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
|
Suture Closure
n=195 Participants
Control : Incision is closed without the placement of a graft material (standard of care control)
|
Total
n=380 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.6 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
45.1 years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
44.8 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
146 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
302 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Weight
|
138 kg
STANDARD_DEVIATION 30 • n=5 Participants
|
143 kg
STANDARD_DEVIATION 34 • n=7 Participants
|
140.6 kg
STANDARD_DEVIATION 32.2 • n=5 Participants
|
|
BMI (Body mass index)
|
48.2 kg/m^2
STANDARD_DEVIATION 8.2 • n=5 Participants
|
48.2 kg/m^2
STANDARD_DEVIATION 7.7 • n=7 Participants
|
48.2 kg/m^2
STANDARD_DEVIATION 7.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: 14 patients in Surgisis Gold group and 8 patients in Suture Closure group were excluded from the analysis, because prior to procedure, either they were found not to meet the inclusion/exclusion criteria, or they chose not to participate.
An obvious defect or interruption of the fascia in the area of the incision that was palpable on clinical examination and/or visible by a cross-sectional imaging modality.
Outcome measures
| Measure |
Surgisis Gold
n=185 Participants
Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
|
Suture Closure
n=195 Participants
Control : Incision is closed without the placement of a graft material (standard of care control)
|
|---|---|---|
|
Incisional Hernia
|
32 participants
|
38 participants
|
Adverse Events
Surgisis Gold
Serious events: 0 serious events
Other events: 87 other events
Deaths: 0 deaths
Suture Closure
Serious events: 0 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Surgisis Gold
n=185 participants at risk
Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
|
Suture Closure
n=195 participants at risk
Control : Incision is closed without the placement of a graft material (standard of care control)
|
|---|---|---|
|
General disorders
Pain
|
17.3%
32/185 • Number of events 32
14 patients in Surgisis Gold group and 8 patients in Suture Closure group were excluded from the analysis, because prior to procedure, either they were found not to meet the inclusion/exclusion criteria, or they chose not to participate.
|
10.8%
21/195 • Number of events 21
14 patients in Surgisis Gold group and 8 patients in Suture Closure group were excluded from the analysis, because prior to procedure, either they were found not to meet the inclusion/exclusion criteria, or they chose not to participate.
|
|
Infections and infestations
Wound infection
|
12.4%
23/185 • Number of events 23
14 patients in Surgisis Gold group and 8 patients in Suture Closure group were excluded from the analysis, because prior to procedure, either they were found not to meet the inclusion/exclusion criteria, or they chose not to participate.
|
4.1%
8/195 • Number of events 8
14 patients in Surgisis Gold group and 8 patients in Suture Closure group were excluded from the analysis, because prior to procedure, either they were found not to meet the inclusion/exclusion criteria, or they chose not to participate.
|
|
Infections and infestations
Wound erythema requiring antibiotics
|
13.5%
25/185 • Number of events 25
14 patients in Surgisis Gold group and 8 patients in Suture Closure group were excluded from the analysis, because prior to procedure, either they were found not to meet the inclusion/exclusion criteria, or they chose not to participate.
|
1.0%
2/195 • Number of events 2
14 patients in Surgisis Gold group and 8 patients in Suture Closure group were excluded from the analysis, because prior to procedure, either they were found not to meet the inclusion/exclusion criteria, or they chose not to participate.
|
|
Infections and infestations
Incisional hernia
|
17.3%
32/185 • Number of events 32
14 patients in Surgisis Gold group and 8 patients in Suture Closure group were excluded from the analysis, because prior to procedure, either they were found not to meet the inclusion/exclusion criteria, or they chose not to participate.
|
19.5%
38/195 • Number of events 38
14 patients in Surgisis Gold group and 8 patients in Suture Closure group were excluded from the analysis, because prior to procedure, either they were found not to meet the inclusion/exclusion criteria, or they chose not to participate.
|
Additional Information
Jason Hodde, Clinical Affairs Manager
Cook Biotech Incorporated
Phone: 765-497-3355
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60