NCT01331798

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Cohera Medical, Inc. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Accepted

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.

Detailed description

Background: Fluid accumulation in dissected tissue planes has been a longstanding problem following surgical procedures. The common use of closed suction drains has been associated with infection risk, wound healing complications, additional scarring, and patient discomfort. Additionally, seroma formation after drain removal often requires invasive treatment. Therapies that can reduce fluid accumulation and decrease the need for drains will have a positive impact on surgical practice. Objective: To study the safety and the preliminary efficacy of a TissuGlu®, a novel surgical adhesive, in the management of wound drainage during abdominoplasty procedures. Material \& Methods: A blinded prospective randomized trial compared drain fluid output (volume) and complication profile in 40 subjects undergoing abdominoplasty with (n=20) or without (n=20) the use of a urethane based adhesive. The TissuGlu® adhesive, which required no mixing or preparation, was administered to the abdominal wall using a custom drop tip applicator prior to closure of the abdominoplasty flap. Two Blake® drains connected to J-VAC suction reservoirs were placed in the wound.

Conditions

• Abdominoplasty

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2011-04-08
• Last updated: 2011-04-08

Locations

3 sites across 1 country: Germany