NCT00521755

Evaluation of Safety and Efficacy of Using Seraffix LTB - (Laser Tissue Bonding) System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Seraffix · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of using Seraffix LTB system for soft tissue bonding.

Detailed description

Dermatologic wounds can be closed by a variety of methods. The choice of a particular closure technique should be based on the patient, wound, tissue characteristics, and anatomic location. The purpose of these closure methods is an approximation of wound lips until the regenerate tissue reach a phase, where it is closed and can sustain the daily tensile forces. Several methods are used for wounds closure such as sutures, staples, tapes, tissue adhesives and laser energy. There have been two fundamental approaches to laser assisted bonding of tissues: 1. Laser welding-heating the approximated edges of cuts in tissues by a laser beam; 2. Laser soldering- applying a biological solder onto the approximated edges and heating the solder (and the underlying tissue). Seraffix has developed the Seraffix LTB (Laser Tissue Bonding) System - a laser system for soft tissue bonding. This innovative system includes features that make laser soldering suitable for clinical use. The Seraffix system is composed of CO2 laser device, propriety grip device (Clamps) and soldering agent (Human Albumin).

Conditions

• Dehiscence, Surgical Wound

Interventions

Type	Name	Description
DEVICE	Seraffix LTB	laser soldering for soft tissue wounds

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-11-01
• Completion: 2010-02-01
• First posted: 2007-08-28
• Last updated: 2011-06-09

Locations

1 site across 1 country: Israel