Evaluation of Safety and Efficacy of Using Seraffix LTB - (Laser Tissue Bonding) System
The purpose of this study is to evaluate the safety and effectiveness of using Seraffix LTB system for soft tissue bonding.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Safety and Efficacy of Using Seraffix LTB - (Laser Tissue Bonding) System|
- Primary study endpoint will be to establish the safety of using the Seraffix System for tissue bonding and wounds closure. Safety will be established by paucity of serious adverse events and adverse events. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- 1. Re-intervention: A subject is scored a success (1) if he had No Re-intervention by 3 months; otherwise he is scored a failure (0). 2. Wound dehiscence of at least 50% of wound length: [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Study Completion Date:||February 2010|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Device: Seraffix LTB
laser soldering for soft tissue wounds
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:
- Laser welding-heating the approximated edges of cuts in tissues by a laser beam;
- 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).