Evaluation of Safety and Efficacy of Using Seraffix LTB - (Laser Tissue Bonding) System

This study has been completed.
Sponsor:
Information provided by:
Seraffix
ClinicalTrials.gov Identifier:
NCT00521755
First received: August 26, 2007
Last updated: June 8, 2011
Last verified: June 2009

August 26, 2007
June 8, 2011
December 2008
November 2009   (final data collection date for primary outcome measure)
Primary study endpoint will be to establish the safety of using the Seraffix System for tissue bonding and wounds closure. Safety will be established by paucity of serious adverse events and adverse events. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
Primary study endpoint will be to establish the safety of using the Seraffix System for tissue bonding and wounds closure. Safety will be established by paucity of serious adverse events and adverse events. [ Time Frame: 3 months ]
Complete list of historical versions of study NCT00521755 on ClinicalTrials.gov Archive Site
1. 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). 2. Wound dehiscence of at least 50% of wound length: [ Time Frame: 3 months ] [ Designated as safety issue: No ]
1. 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). 2. Wound dehiscence of at least 50% of wound length: [ Time Frame: 3 months ]
Not Provided
Not Provided
 
Evaluation of Safety and Efficacy of Using Seraffix LTB - (Laser Tissue Bonding) System
Evaluation of Safety and Efficacy of Using Seraffix LTB - (Laser Tissue Bonding) System

The purpose of this study is to evaluate the safety and effectiveness of using Seraffix LTB system for soft tissue bonding.

Dermatologic wounds can be closed by a variety of methods. The choice of a particular closure technique should be based on the patient, wound, tissue characteristics, and anatomic location. The purpose of these closure methods is an approximation of wound lips until the regenerate tissue reach a phase, where it is closed and can sustain the daily tensile forces.

Several methods are used for wounds closure such as sutures, staples, tapes, tissue adhesives and laser energy. There have been two fundamental approaches to laser assisted bonding of tissues:

  1. Laser welding-heating the approximated edges of cuts in tissues by a laser beam;
  2. Laser soldering- applying a biological solder onto the approximated edges and heating the solder (and the underlying tissue).

Seraffix has developed the Seraffix LTB (Laser Tissue Bonding) System - a laser system for soft tissue bonding. This innovative system includes features that make laser soldering suitable for clinical use. The Seraffix system is composed of CO2 laser device, propriety grip device (Clamps) and soldering agent (Human Albumin).

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Dehiscence, Surgical Wound
Device: Seraffix LTB
laser soldering for soft tissue wounds
Experimental: A
Intervention: Device: Seraffix LTB
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
February 2010
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male/Female age 18-60.
  • Subject is scheduled for laparoscopic cholecystectomy surgery.
  • Subject able to comprehend and give informed consent for participation in this study.
  • Signed informed consent form.

Exclusion Criteria:

  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to screening.
  • Acute infection requiring intravenous antibiotics at the time of screening.
  • Bleeding, coagulation and or clotting disorders.
  • Diabetes mellitus: IDDM or NIDDM.
  • HIV positive or any other immunosuppressive disorder.
  • Renal failure (Serum creatinine >2.0 mg/dl).
  • Inflammatory and or allergic diseases or condition of the skin: Psoriasis, Eczema or dermatitis.
  • Any concomitant infection - viral or bacterial.
  • Drug abuse.
  • Use of steroids.
  • Infection / abscess / pain in treatment target area.
  • Pregnancy or lactating.
  • History of keloid scarring.
  • Use of aspirin or antioxidants
  • Subject is suffering extreme general weakness.
  • Subject objects to the study protocol.
  • Known cognitive or psychiatric disorder
  • Concurrent participation in any other clinical study.
  • Physician objection.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00521755
SF-01
No
Dr. Hanna Levy, Clinical Study Consultant, Seraffix
Seraffix
Not Provided
Principal Investigator: Ossama Hatoum, Dr. HaEmek Medical Center, Israel
Seraffix
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP