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Cohera TissuGlu® Surgical Adhesive in the Management of Wound Drainage

NCT01526954 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2013-12-05

No results posted yet for this study

Summary

This study is designed to evaluate the safety and efficacy of the device while reducing the amount of drainage from surgical wounds following large flap surgical procedures, in this case abdominoplasty, as compared to the standard of care (closure techniques). It is hypothesized that the use of the Cohera device will facilitate reduction or closure of dead space when applied to planar surfaces created during an abdominoplasty procedure.

Conditions

  • Abdominoplasty

Interventions

DEVICE

TissuGlu Surgical Adhesive

TissuGlu Surgical Adhesive to be used prior to closure of the large tissue flap in abdominoplasty cases.

Sponsors & Collaborators

  • Cohera Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-09-30
Completion
2013-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01526954 on ClinicalTrials.gov