Evaluation of Surgisis Gold Graft for Incision Reinforcement After Open Bariatric Surgery
Study Details
Study Description
Brief Summary
The primary objective is to compare the effectiveness of the Surgisis Gold Graft to suture closure alone in preventing an incisional hernia after open bariatric surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
This will be a prospective, randomized clinical trial comparing outcomes of use of a sublay of Surgisis Gold Graft for tissue reinforcement, as compared to suture closure alone in evaluating incidence of incisional hernias. Prior to undergoing open bariatric surgery, patients will be randomized to receive either Surgisis Gold Graft or suture closure alone. Subjects will be seen for follow-up visits at six weeks, three months, six months, one year and two years post-operatively. Patients may see their primary care physician for the one and two follow-up visits.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Surgisis Gold Graft |
Device: Surgisis Gold Graft
Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
|
| Active Comparator: 2 Control |
Procedure: Control
Incision is closed without the placement of a graft material (standard of care control)
|
Outcome Measures
Primary Outcome Measures
- Incisional Hernia [2 years]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Planned operative approach via upper midline incision with goal of weight loss
-
18 years of age or older
-
Body mass index (BMI) >= 30 kg/m2
-
Documented history of non-surgical attempts at weight loss
-
Patients undergoing reoperation for a failed previous bariatric procedure are eligible provided the operation is being performed for weight loss and provided at the time of reoperation there is no incisional hernia
-
Patients with small, non-incarcerated, previously unrepaired umbilical hernias are acceptable provided the hernia defect is no greater than 2.5 cm in diameter
Exclusion Criteria:
-
Patients with pre-existing midline abdominal wall incisional hernia or diastasis rectus
-
Patients undergoing repeat bariatric surgery for complications of a previous bariatric procedure
-
Patients with a previous upper midline incision found to have an incisional hernia
-
Patients with connective tissue disorders known to predispose to hernia formation
-
Active infection at the time of proposed surgery
-
Sensitivity or religious objections to porcine products
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic Foundation | Rochester | Minnesota | United States | 55905 |
| 2 | St. Mary's Medical | Richmond | Virginia | United States | 23226 |
Sponsors and Collaborators
- Cook Group Incorporated
- Cook Biotech Incorporated
- MED Institute, Incorporated
Investigators
- Principal Investigator: Michael Sarr, MD, Mayo Clinic Foundation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1076-05-00
- 04-007
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Surgisis Gold | Suture Closure |
|---|---|---|
| Arm/Group Description | Surgisis Gold Graft is placed as an underlay following open bariatric surgery. | Control : Incision is closed without the placement of a graft material (standard of care control) |
| Period Title: Overall Study | ||
| STARTED | 199 | 203 |
| COMPLETED | 139 | 141 |
| NOT COMPLETED | 60 | 62 |
Baseline Characteristics
| Arm/Group Title | Surgisis Gold | Suture Closure | Total |
|---|---|---|---|
| Arm/Group Description | Surgisis Gold Graft is placed as an underlay following open bariatric surgery. | Control : Incision is closed without the placement of a graft material (standard of care control) | Total of all reporting groups |
| Overall Participants | 185 | 195 | 380 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
44.6
(10.6)
|
45.1
(12.1)
|
44.8
(11.4)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
146
78.9%
|
156
80%
|
302
79.5%
|
| Male |
39
21.1%
|
39
20%
|
78
20.5%
|
| Weight (kg) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg] |
138
(30)
|
143
(34)
|
140.6
(32.2)
|
| BMI (Body mass index) (kg/m^2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg/m^2] |
48.2
(8.2)
|
48.2
(7.7)
|
48.2
(7.9)
|
Outcome Measures
| Title | Incisional Hernia |
|---|---|
| Description | 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. |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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. |
| Arm/Group Title | Surgisis Gold | Suture Closure |
|---|---|---|
| Arm/Group Description | Surgisis Gold Graft is placed as an underlay following open bariatric surgery. | Control : Incision is closed without the placement of a graft material (standard of care control) |
| Measure Participants | 185 | 195 |
| Number [participants] |
32
17.3%
|
38
19.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Surgisis Gold, Suture Closure |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.60 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||
| Arm/Group Title | Surgisis Gold | Suture Closure | ||
| Arm/Group Description | Surgisis Gold Graft is placed as an underlay following open bariatric surgery. | Control : Incision is closed without the placement of a graft material (standard of care control) | ||
All Cause Mortality |
||||
| Surgisis Gold | Suture Closure | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Surgisis Gold | Suture Closure | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/185 (0%) | 0/195 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Surgisis Gold | Suture Closure | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 87/185 (47%) | 62/195 (31.8%) | ||
| General disorders | ||||
| Pain | 32/185 (17.3%) | 32 | 21/195 (10.8%) | 21 |
| Infections and infestations | ||||
| Wound infection | 23/185 (12.4%) | 23 | 8/195 (4.1%) | 8 |
| Wound erythema requiring antibiotics | 25/185 (13.5%) | 25 | 2/195 (1%) | 2 |
| Incisional hernia | 32/185 (17.3%) | 32 | 38/195 (19.5%) | 38 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Jason Hodde, Clinical Affairs Manager |
|---|---|
| Organization | Cook Biotech Incorporated |
| Phone | 765-497-3355 |
| jhodde@cookbiotech.com |
- 1076-05-00
- 04-007