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

Evaluation of Safety and Efficacy of Using Seraffix LTB - (Laser Tissue Bonding) System for Excisional Biopsy Wounds Closure

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

Study Overview

• Status: Terminated
• Conditions: Dehiscence, Surgical Wound
• Intervention / Treatment: Device: Seraffix LTB

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).

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Rambam Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A	Device: Seraffix LTB; wounds closure by using laser and albumin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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:	3 months

Collaborators and Investigators

• Sponsor: Seraffix
• Investigators: Principal Investigator: Yehuda Ullmann, Dr., Rambam Medical Center, Haifa Israel

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: September 4, 2007
• First Submitted That Met QC Criteria: September 4, 2007
• First Posted (Estimate): September 5, 2007

Study Record Updates

• Last Update Posted (Estimate): June 9, 2011
• Last Update Submitted That Met QC Criteria: June 8, 2011
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: Laser bonding soft tissue albumin
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Wounds and Injuries; Surgical Wound; Surgical Wound Dehiscence
• Other Study ID Numbers: SF-EB -01