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Closure of Skin Incision Using CO2 Laser

Primary Purpose

Wound

Status
Completed
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Temperature Controlled Laser Soldering
Sponsored by
Avraham Katzir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound focused on measuring Incision, Wound Closure, Laser Tissue Soldering

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Department of Surgery B, "HaEmek" Medical Center
  • Haemek Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Temperature Controlled Laser Soldering

Arm Description

Efficacy and safety of Temperature Controlled Laser Soldered wound incisions closure

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
Wound dehiscence of at least 50% of wound length

Full Information

First Posted
May 25, 2014
Last Updated
May 28, 2014
Sponsor
Avraham Katzir
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1. Study Identification

Unique Protocol Identification Number
NCT02149979
Brief Title
Closure of Skin Incision Using CO2 Laser
Official Title
Closure of Skin Incision Using CO2 Laser
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Avraham Katzir

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound
Keywords
Incision, Wound Closure, Laser Tissue Soldering

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Temperature Controlled Laser Soldering
Arm Type
Experimental
Arm Description
Efficacy and safety of Temperature Controlled Laser Soldered wound incisions closure
Intervention Type
Device
Intervention Name(s)
Temperature Controlled Laser Soldering
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
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).
Time Frame
3 months
Title
Wound dehiscence of at least 50% of wound length
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doron Kopelman, MD
Organizational Affiliation
Department of Surgery B, "HaEmek" Medical Center, Afula,
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abraham Katzir, PhD
Organizational Affiliation
The applied physics group, Tel Aviv University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David Simhon, MD, PhD
Organizational Affiliation
The applied physics group, Tel Aviv University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Surgery B, "HaEmek" Medical Center
City
Afula
ZIP/Postal Code
18341
Country
Israel
Facility Name
Haemek Medical Center
City
Afula
ZIP/Postal Code
18341
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
17245173
Citation
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.
Results Reference
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PubMed Identifier
15278922
Citation
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.
Results Reference
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PubMed Identifier
15278923
Citation
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.
Results Reference
background
PubMed Identifier
11573230
Citation
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.
Results Reference
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Closure of Skin Incision Using CO2 Laser

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