NCT00274625

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
402

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2006

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

November 12, 2014

Completed
Last Updated

November 12, 2014

Status Verified

November 1, 2014

Enrollment Period

7.1 years

First QC Date

January 9, 2006

Results QC Date

October 24, 2014

Last Update Submit

November 10, 2014

Conditions

HerniaObesity

Keywords

BiomaterialsBariatric SurgeryHernia, Prevention ofObesityBypass SurgeryIncisional HerniaVentral Hernia

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years

Study Arms (2)

1

EXPERIMENTAL

Surgisis Gold Graft

Device: Surgisis Gold Graft

2

ACTIVE COMPARATOR

Control

Procedure: Control

Interventions

Surgisis Gold GraftDEVICE

Surgisis Gold Graft is placed as an underlay following open bariatric surgery.

1
ControlPROCEDURE

Incision is closed without the placement of a graft material (standard of care control)

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Planned operative approach via upper midline incision with goal of weight loss
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic Foundation

Rochester, Minnesota, 55905, United States

Location

St. Mary's Medical

Richmond, Virginia, 23226, United States

Location

Related Publications (1)

  • 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.

    PMID: 25239343RESULT

MeSH Terms

Conditions

HerniaObesityIncisional HerniaHernia, Ventral

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPostoperative ComplicationsPathologic ProcessesHernia, Abdominal

Results Point of Contact

Title
Jason Hodde, Clinical Affairs Manager
Organization
Cook Biotech Incorporated
jhodde@cookbiotech.com
765-497-3355

Study Officials

  • Michael Sarr, MD

    Mayo Clinic Foundation

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2006

First Posted

January 11, 2006

Study Start

August 1, 2005

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

November 12, 2014

Results First Posted

November 12, 2014

Record last verified: 2014-11

Locations

US(2)