HerniaNCT00274625
Evaluation of Surgisis Gold Graft for Incision Reinforcement After Open Bariatric Surgery
A study testing Surgisis Gold Graft in people with Hernia and Obesity, run by Cook Group Incorporated at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Surgisis Gold Graft
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 402 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2005to Sep 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
St. Mary's Medical
Richmond, Virginia, 23226
Mayo Clinic Foundation
Rochester, Minnesota, 55905
About this study
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.
Read the 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.
- Being tested
- Surgisis Gold Graft, Control
- Keywords
- Biomaterials, Bariatric Surgery, Hernia, Prevention of, Obesity, Bypass Surgery, Incisional Hernia, Ventral Hernia
- Medical subject headings
- Hernia, Obesity, Incisional Hernia, Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgisis Gold GraftDevice
Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
ControlProcedure or surgery
Incision is closed without the placement of a graft material (standard of care control)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Surgisis Gold Graft Receives: Device: Surgisis Gold Graft |
| 2 | Active comparator | Control Receives: Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incisional Hernia
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2006 (estimated)
- Study startAug 2005
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cook Biotech Incorporated, MED Institute, Incorporated
- Responsible party
- Sponsor
- Investigators
- Michael Sarr, MD, Principal investigator, Mayo Clinic Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274625
- Sponsor's protocol ID
- 1076-05-00
- Other IDs
- 04-007
- Status last verified
- Nov 2014
- First submitted
- 9 Jan 2006
- Last updated
- 12 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sarr MG, Hutcher NE, Snyder S, Hodde J, Carmody B. A prospective, randomized, multicenter trial of Surgisis Gold, a biologic prosthetic, as a sublay reinforcement of the fascial closure after open bariatric surgery. Surgery. 2014 Oct;156(4):902-8. doi: 10.1016/j.surg.2014.06.022.
PubMed 25239343
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Surgisis Gold Graft for Incision Reinforcement After Open Bariatric Surgery
- ClinicalTrials.gov ID
- NCT00274625
- Acronym / sponsor ID
- 1076-05-00
- Keywords
- Biomaterials, Bariatric Surgery, Hernia, Prevention of, Obesity, Bypass Surgery, Incisional Hernia, Ventral Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- Cook Biotech Incorporated, MED Institute, Incorporated
- Study start
- Aug 2005
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 11 Jan 2006 (estimated)
- Results
- Posted 12 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Surgisis Gold GraftSurgisis Gold Graft |
| 2 | Active comparator | Procedure: ControlControl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgisis Gold GraftSurgisis Gold Graft is placed as an underlay following open bariatric surgery. | Device | 1 |
| ControlIncision is closed without the placement of a graft material (standard of care control) | Procedure or surgery | 2 |
Primary outcome
Incisional Hernia
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25239343Sarr MG, Hutcher NE, Snyder S, Hodde J, Carmody B. A prospective, randomized, multicenter trial of Surgisis Gold, a biologic prosthetic, as a sublay reinforcement of the fascial closure after open bariatric surgery. Surgery. 2014 Oct;156(4):902-8. doi: 10.1016/j.surg.2014.06.022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Sarr, MD principal investigator
Mayo Clinic Foundation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgisis Gold Graft in people with Hernia and Obesity, run by Cook Group Incorporated at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incisional Hernia (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00274625, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2014.