Evaluation of Safety and Efficacy of Using Seraffix LTB - System for Excisional Biopsy Wounds Closure
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|ClinicalTrials.gov Identifier: NCT00525434|
Recruitment Status : Terminated (sponsor has decide to pospone this study)
First Posted : September 5, 2007
Last Update Posted : June 9, 2011
|Condition or disease||Intervention/treatment||Phase|
|Dehiscence, Surgical Wound||Device: Seraffix LTB||Not Applicable|
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:
- 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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Safety and Efficacy of Using Seraffix LTB - (Laser Tissue Bonding) System for Excisional Biopsy Wounds Closure|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||November 2009|
Device: Seraffix LTB
wounds closure by using laser and albumin
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00525434
|RAMBAM Medical center|
|Principal Investigator:||Yehuda Ullmann, Dr.||RAMBAM Medical Center, Haifa Israel|