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Evaluation of Cohera TissuGlu in the Management of Wound Drainage Following Abdominoplasty

NCT01331798 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-04-08

No results posted yet for this study

Summary

A blinded, prospective, randomized trial in 40 abdominoplasty cases at three sites to study the safety and the preliminary efficacy of TissuGlu®, a novel surgical adhesive, in the management of wound drainage during abdominoplasty procedures.

Conditions

  • Abdominoplasty

Interventions

DEVICE

Cohera TissuGlu Surgical Adhesive

TissuGlu device used prior to closing of the flap in the abdominoplasty procedure.

PROCEDURE

Control- Standard of care

Control Arm- no TissuGlu device used. Standard abdominoplasty procedure followed.

Sponsors & Collaborators

  • Cohera Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • Germany

Study Locations

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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 NCT01331798 on ClinicalTrials.gov