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

Dehiscence, Surgical Wound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00525434
• Other study ID #: SF-EB -01
• Status: Terminated
• Phase: N/A
• First received: September 4, 2007
• Last updated: June 8, 2011
• Start date: November 2008
• Est. completion date: November 2009

Study information

• Verified date: May 2008
• Source: Seraffix
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: November 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dehiscence, Surgical Wound
• Surgical Wound Dehiscence

Intervention

Device:
• Seraffix LTB
wounds closure by using laser and albumin

Locations

Country	Name	City	State
Israel	RAMBAM Medical center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Seraffix

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No