## Protocol Section
### Identification Module
**NCT ID:** NCT02149979

**Brief Title:** Closure of Skin Incision Using CO2 Laser

**Official Title:** Closure of Skin Incision Using CO2 Laser

#### Organization Study ID Info
**ID:** Katzir #1
#### Organization
**Class:** OTHER
**Full Name:** Tel Aviv University
### Status Module
#### Completion Date
**Date:** 2009-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-05-29

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-05-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-01

**Type:** ACTUAL

#### Start Date
**Date:** 2007-03

**Status Verified Date:** 2014-05

#### Study First Post Date
**Date:** 2014-05-29
**Type:** ESTIMATED
**Study First Submit Date:** 2014-05-25
**Study First Submit QC Date:** 2014-05-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Avraham Katzir

#### Responsible Party

**Investigator Affiliation:** Tel Aviv University

**Investigator Full Name:** Avraham Katzir

**Investigator Title:** Head of the applied physics group

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Wound

**Keywords:**

- Incision

- Wound Closure

- Laser Tissue Soldering

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 10

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Efficacy and safety of Temperature Controlled Laser Soldered wound incisions closure

**Intervention Names:**

- Device: Temperature Controlled Laser Soldering

**Label:** Temperature Controlled Laser Soldering

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Temperature Controlled Laser Soldering

**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.

**Name:** Temperature Controlled Laser Soldering

**Type:** DEVICE

### Outcomes Module

#### 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.

**Time Frame:** 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).

**Time Frame:** 3 months

**Measure:** Wound dehiscence of at least 50% of wound length

**Time Frame:** 3 months

### Eligibility Module

**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.

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Afula

**Country:** Israel

**Facility:** Department of Surgery B, "HaEmek" Medical Center

**Zip:** 18341

**Location 2:**

**City:** Afula

**Country:** Israel

**Facility:** Haemek Medical Center

**Zip:** 18341

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Surgery B, "HaEmek" Medical Center, Afula,

**Name:** Doron Kopelman, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** The applied physics group, Tel Aviv University

**Name:** Abraham Katzir, PhD

**Role:** STUDY_CHAIR

**Official 3:**

**Affiliation:** The applied physics group, Tel Aviv University

**Name:** David Simhon, MD, PhD

**Role:** STUDY_DIRECTOR

### References Module

#### 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.

**PMID:** 17245173

**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.

**PMID:** 15278922

**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.

**PMID:** 15278923

**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.

**PMID:** 11573230

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M1112

- Name: Surgical Wound

- Relevance: HIGH

- As Found: Incision

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000072836

- Term: Surgical Wound

### Misc Info Module

- Version Holder: 2024-05-24
