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

NCT00525434 | Terminated

• 1 other identifier: SF-EB -01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dehiscence, Surgical Wound

Keywords

Laser bonding soft tissue albumin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

A

EXPERIMENTAL

Device: Seraffix LTB

Interventions

Seraffix LTB DEVICE

wounds closure by using laser and albumin

A

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seraffix: lead

Study Sites (1)

RAMBAM Medical center

Haifa, Israel

Location

MeSH Terms

Conditions

Surgical Wound Dehiscence

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yehuda Ullmann, Dr.

  RAMBAM Medical Center, Haifa Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 4, 2007
• First Posted: September 5, 2007
• Study Start: November 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: November 1, 2009
• Last Updated: June 9, 2011

Record last verified: 2008-05

Locations

IL (1)