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

Dehiscence, Surgical Wound Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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). ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dehiscence, Surgical Wound
• Surgical Wound Dehiscence

• NCT number: NCT00521755
• Study type: Interventional
• Source: Seraffix
• Status: Completed
• Phase: N/A
• Start date: December 2008
• Completion date: February 2010