Clinical trial NCT02149979: Closure of Skin Incision Using CO2 Laser
Official title: Closure of Skin Incision Using CO2 Laser
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Wound
Keywords: Incision
Wound Closure
Laser Tissue Soldering
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 3 months
Secondary outcomes:
measure: 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).
timeFrame: 3 months
measure: Wound dehiscence of at least 50% of wound length
timeFrame: 3 months
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Department of Surgery B, "HaEmek" Medical Center
city: Afula
country: Israel
facility: Haemek Medical Center
Study officials:
affiliation: Department of Surgery B, "HaEmek" Medical Center, Afula,
name: Doron Kopelman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The applied physics group, Tel Aviv University
name: Abraham Katzir, PhD
role: STUDY_CHAIR
affiliation: The applied physics group, Tel Aviv University
name: David Simhon, MD, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.