Closure of Skin Incision Using CO2 Laser

Study Overview
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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.

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.

Official Title
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Closure of Skin Incision Using CO2 Laser

Conditions
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Wound

Intervention / Treatment
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* Device: Temperature Controlled Laser Soldering


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Temperature Controlled Laser Soldering<br>Efficacy and safety of Temperature Controlled Laser Soldered wound incisions closure | Device: Temperature Controlled Laser Soldering<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary study endpoint will be to establish the safety of using the Temperature Controlled Laser Soldering System for skin bonding and wounds closure. Safety will be established by paucity of serious adverse events and adverse events. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). |  | 3 months | 
| Wound dehiscence of at least 50% of wound length |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incision, Wound Closure, Laser Tissue Soldering