Closure of Skin Incision Using CO2 Laser

Avraham Katzir

Status and phase

Completed

Phase 1

Conditions

Wound

Treatments

Device: Temperature Controlled Laser Soldering

Study type

Interventional

Funder types

Other

Identifiers

NCT02149979

Katzir #1

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of using Temperature Controlled Laser Soldering System for soft tissue bonding.

Full description

Skin incisions can be closed by a variety of method which create temporary approximation of the wound edges until natural healing process ensue and reach a phase, where it is closed and can sustain the daily tensile forces.

The wound closure devices include sutures, staples, tapes, tissue adhesives. The Applied Physics group at the Tel Aviv University has developed a Temperature Controlled CO2 Laser Soldering system for soft tissue bonding.

This system includes features that make laser soldering suitable for clinical use. The Temperature Controlled Laser Soldering System is composed of CO2 fiberoptic laser device, Infrared fiber-optic radiometer, a computerized temperature control program, propriety grip device (Clamps) and concentrated Human Albumin as a soldering agent.

Enrollment

10 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male/Female age 18-65.
Subject is scheduled for laparoscopic cholecystectomy surgery.
Subject able to comprehend and sign informed consent for participation in this study.
Ability to comply with the study procedures and follow-up visits

Exclusion criteria

Subject has a history of hypertrophic or keloid scar formation
Subject is a pregnant and/or nursing woman
Subject has a known allergy to blood products
Subject is suffering from a bleeding disorders or using anticoagulant medications
Subject is suffering from hepatic or renal disorder
Subject is suffering from rheumatic and / or collagen disorder
Subject is using steroids
Subject is suffering from immunosuppressive disorder
Subject is suffering from Ischemic Heart Disease (IHD)
Subject is suffering from neoplastic disorder
Subject who has had an active illness within 4 weeks of study enrollment
Subject is participating in another study for an investigational drug and/or device within 3 months of study enrollment
Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study.