Evaluation of Safety and Efficacy of Using Seraffix LTB - System for Excisional Biopsy Wounds Closure

This study has been terminated.
(sponsor has decide to pospone this study)
Sponsor:
Information provided by:
Seraffix
ClinicalTrials.gov Identifier:
NCT00525434
First received: September 4, 2007
Last updated: June 8, 2011
Last verified: May 2008
  Purpose

The purpose of this study is to evaluate the safety and effectiveness of using Seraffix LTB system for excisional biopsy wounds closure


Condition Intervention
Dehiscence, Surgical Wound
Device: Seraffix LTB

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Efficacy of Using Seraffix LTB - (Laser Tissue Bonding) System for Excisional Biopsy Wounds Closure

Further study details as provided by Seraffix:

Primary Outcome Measures:
  • Primary study endpoint will be to establish the safety of using the Seraffix System for excisional biopsy wounds closure. Safety will be established by paucity of serious adverse events and adverse events. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

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: [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: November 2008
Study Completion Date: November 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Device: Seraffix LTB
wounds closure by using laser and albumin

Detailed Description:

Excisional biopsy of the skin is a biopsy in which an entire lesion is removed. An excisional biopsy is in contrast to an incisional biopsy in which only a sample of tissue is cut into and removed. It is most frequently done to diagnose a skin growth such as a mole, or cancer of the skin.

The most common method of wound closure of skin excisions is interrupted nonabsorbable sutures. The sutures should be removed as soon as adequate intrinsic bonding strength is sufficient, depending mostly on the specific body region (from 5-7 days for the face and up to 12-14 days for trunk and extremities).

Laser energy, also known as laser welding, has been used on limited basis as an alternative to traditional wound closure method. 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).

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male/Female age 18-60.
  2. Subject is scheduled for excisional biopsy surgery.
  3. Subject able to comprehend and give informed consent for participation in this study.
  4. Signed informed consent form.

Exclusion Criteria:

  1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to screening.
  2. Acute infection requiring intravenous antibiotics at the time of screening.
  3. Bleeding, coagulation and or clotting disorders.
  4. Diabetes mellitus: IDDM or NIDDM.
  5. HIV positive or any other immunosuppressive disorder.
  6. Renal failure (Serum creatinine >2.0 mg/dl).
  7. Inflammatory and or allergic diseases or condition of the skin: Psoriasis, Eczema or dermatitis.
  8. Any concomitant infection - viral or bacterial.
  9. Drug abuse.
  10. Use of steroids.
  11. Infection / abscess / pain in treatment target area.
  12. Pregnancy or lactating.
  13. History of keloid scarring.
  14. Use of aspirin or antioxidants
  15. Subject is suffering extreme general weakness.
  16. Subject objects to the study protocol.
  17. Known cognitive or psychiatric disorder
  18. Concurrent participation in any other clinical study.
  19. Physician objection.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525434

Locations
Israel
RAMBAM Medical center
Haifa, Israel
Sponsors and Collaborators
Seraffix
Investigators
Principal Investigator: Yehuda Ullmann, Dr. RAMBAM Medical Center, Haifa Israel
  More Information

No publications provided

Responsible Party: Dr. Hanna Levy, Clinical Study Consultant, Seraffix
ClinicalTrials.gov Identifier: NCT00525434     History of Changes
Other Study ID Numbers: SF-EB -01
Study First Received: September 4, 2007
Last Updated: June 8, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Seraffix:
Laser bonding soft tissue albumin

Additional relevant MeSH terms:
Surgical Wound Dehiscence
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014