Back to resultsEvaluation of Safety and Efficacy of Using Seraffix LTB - (Laser Tissue Bonding) System
Primary Purpose
Dehiscence, Surgical Wound
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Seraffix LTB
Sponsored by
About this trial
This is an interventional treatment trial for Dehiscence, Surgical Wound focused on measuring Laser bonding soft tissue albumin
Eligibility Criteria
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.
Sites / Locations
- Haemek Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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:
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00521755
Brief Title
Evaluation of Safety and Efficacy of Using Seraffix LTB - (Laser Tissue Bonding) System
Official Title
Evaluation of Safety and Efficacy of Using Seraffix LTB - (Laser Tissue Bonding) System
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Seraffix
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 Seraffix LTB system for soft tissue bonding.
Detailed Description
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:
Laser welding-heating the approximated edges of cuts in tissues by a laser beam;
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dehiscence, Surgical Wound
Keywords
Laser bonding soft tissue albumin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Seraffix LTB
Intervention Description
laser soldering for soft tissue wounds
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ossama Hatoum, Dr.
Organizational Affiliation
HaEmek Medical Center, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haemek Medical Center
City
Afula
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Safety and Efficacy of Using Seraffix LTB - (Laser Tissue Bonding) System
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