NCT00525434

Evaluation of Safety and Efficacy of Using Seraffix LTB - System for Excisional Biopsy Wounds Closure

Evaluation of Safety and Efficacy of Using Seraffix LTB - (Laser Tissue Bonding) System for Excisional Biopsy Wounds Closure

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (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 excisional biopsy wounds closure

Detailed description

Excisional biopsy of the skin is a biopsy in which an entire lesion is removed. An excisional biopsy is in contrast to an incisional biopsy in which only a sample of tissue is cut into and removed. It is most frequently done to diagnose a skin growth such as a mole, or cancer of the skin. The most common method of wound closure of skin excisions is interrupted nonabsorbable sutures. The sutures should be removed as soon as adequate intrinsic bonding strength is sufficient, depending mostly on the specific body region (from 5-7 days for the face and up to 12-14 days for trunk and extremities). Laser energy, also known as laser welding, has been used on limited basis as an alternative to traditional wound closure method. 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	wounds closure by using laser and albumin

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-07-01
• Completion: 2009-11-01
• First posted: 2007-09-05
• Last updated: 2011-06-09

Locations

1 site across 1 country: Israel