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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00521755
• Other study ID #: SF-01
• Status: Completed
• Phase: N/A
• First received: August 26, 2007
• Last updated: June 8, 2011
• Start date: December 2008
• Est. completion date: February 2010

Study information

• Verified date: June 2009
• Source: Seraffix
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Male/Female age 18-60.

• Subject is scheduled for laparoscopic cholecystectomy surgery.

• Subject able to comprehend and give informed consent for participation in this study.

• Signed informed consent form.

Exclusion Criteria:

• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to screening.

• Acute infection requiring intravenous antibiotics at the time of screening.

• Bleeding, coagulation and or clotting disorders.

• Diabetes mellitus: IDDM or NIDDM.

• HIV positive or any other immunosuppressive disorder.

• Renal failure (Serum creatinine >2.0 mg/dl).

• Inflammatory and or allergic diseases or condition of the skin: Psoriasis, Eczema or dermatitis.

• Any concomitant infection - viral or bacterial.

• Drug abuse.

• Use of steroids.

• Infection / abscess / pain in treatment target area.

• Pregnancy or lactating.

• History of keloid scarring.

• Use of aspirin or antioxidants

• Subject is suffering extreme general weakness.

• Subject objects to the study protocol.

• Known cognitive or psychiatric disorder

• Concurrent participation in any other clinical study.

• Physician objection.

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

Intervention

Device:
• Seraffix LTB
laser soldering for soft tissue wounds

Locations

Country	Name	City	State
Israel	Haemek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
Seraffix

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		3 months	Yes
Secondary	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:		3 months	No