Closure of Skin Incision Using CO2 Laser

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

Study Overview

• Status: Completed
• Conditions: Wound
• Intervention / Treatment: Device: Temperature Controlled Laser Soldering

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Israel
  • Afula, Israel, 18341
    • Department of Surgery B, "HaEmek" Medical Center
  • Afula, Israel, 18341
    • HaEmek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Temperature Controlled Laser Soldering; Efficacy and safety of Temperature Controlled Laser Soldered wound incisions closure	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Avraham Katzir
• Investigators: Principal Investigator: Doron Kopelman, MD, Department of Surgery B, "HaEmek" Medical Center, Afula,; Study Chair: Abraham Katzir, PhD, The applied physics group, Tel Aviv University; Study Director: David Simhon, MD, PhD, The applied physics group, Tel Aviv University

Publications and helpful links

General Publications

• Simhon D, Halpern M, Brosh T, Vasilyev T, Ravid A, Tennenbaum T, Nevo Z, Katzir A. Immediate tight sealing of skin incisions using an innovative temperature-controlled laser soldering device: in vivo study in porcine skin. Ann Surg. 2007 Feb;245(2):206-13. doi: 10.1097/01.sla.0000232554.13719.10.
• Simhon D, Brosh T, Halpern M, Ravid A, Vasilyev T, Kariv N, Katzir A, Nevo Z. Closure of skin incisions in rabbits by laser soldering: I: Wound healing pattern. Lasers Surg Med. 2004;35(1):1-11. doi: 10.1002/lsm.20074.
• Brosh T, Simhon D, Halpern M, Ravid A, Vasilyev T, Kariv N, Nevo Z, Katzir A. Closure of skin incisions in rabbits by laser soldering II: Tensile strength. Lasers Surg Med. 2004;35(1):12-7. doi: 10.1002/lsm.20073.
• Simhon D, Ravid A, Halpern M, Cilesiz I, Brosh T, Kariv N, Leviav A, Katzir A. Laser soldering of rat skin, using fiberoptic temperature controlled system. Lasers Surg Med. 2001;29(3):265-73. doi: 10.1002/lsm.1118.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: May 25, 2014
• First Submitted That Met QC Criteria: May 28, 2014
• First Posted (Estimate): May 29, 2014

Study Record Updates

• Last Update Posted (Estimate): May 29, 2014
• Last Update Submitted That Met QC Criteria: May 28, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Incision; Wound Closure; Laser Tissue Soldering
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: Katzir #1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No