CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 402 enrolled
Drug / intervention
Surgisis Gold Graft +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00274625
NCT00274625N/ACompleted
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Evaluation of Surgisis Gold Graft for Incision Reinforcement After Open Bariatric Surgery

Cook Group Incorporated·interventional·Posted Jan 11, 2006·Updated Nov 12, 2014

In Brief

A clinical study evaluating Surgisis Gold Graft and Control for Hernia and Obesity. Completed, enrolled 402 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHernia, Obesity
CountriesUnited States
CollaboratorsCook Biotech Incorporated, MED Institute, Incorporated

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 11, 2006
Enrollment StartAug 1, 2005
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 20.5 years ago

Interventions

Surgisis Gold Graftdevice

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

Controlprocedure

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