Closure of Skin Incision Using CO2 Laser

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-01-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Wound

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Temperature Controlled Laser Soldering

Efficacy and safety of Temperature Controlled Laser Soldered wound incisions closure

Group Type EXPERIMENTAL

Temperature Controlled Laser Soldering

Intervention Type DEVICE

This study had a prospective within-subject design. Patients allocated to laparoscopic cholecystectomy procedure were enrolled. After the completion of the laparoscopic cholecystectomy surgical procedure, 4 trocar port sites were randomly either sutured or laser soldered by employing the temperature-controlled laser soldering system.

Interventions

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Temperature Controlled Laser Soldering

This study had a prospective within-subject design. Patients allocated to laparoscopic cholecystectomy procedure were enrolled. After the completion of the laparoscopic cholecystectomy surgical procedure, 4 trocar port sites were randomly either sutured or laser soldered by employing the temperature-controlled laser soldering system.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No