Closure of Skin Incision Using CO2 Laser

Wound Clinical Trial

Official title:

Closure of Skin Incision Using CO2 Laser

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02149979
• Other study ID #: Katzir #1
• Status: Completed
• Phase: Phase 1
• First received: May 25, 2014
• Last updated: May 28, 2014
• Start date: March 2007
• Est. completion date: January 2009

Study information

• Verified date: May 2014
• Source: Tel Aviv University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2009
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Wound

Intervention

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.

Locations

Country	Name	City	State
Israel	Department of Surgery B, "HaEmek" Medical Center	Afula
Israel	Haemek Medical Center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
Avraham Katzir

Country where clinical trial is conducted

Israel, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	Wound dehiscence of at least 50% of wound length		3 months	No