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sponsor has decide to pospone this study
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The purpose of this study is to evaluate the safety and effectiveness of using Seraffix LTB system for excisional biopsy wounds closure
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seraffix LTB | Device | wounds closure by using laser and albumin |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yehuda Ullmann, Dr. | RAMBAM Medical Center, Haifa Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RAMBAM Medical center | Haifa | Israel |
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| ID | Term |
|---|---|
| D013529 | Surgical Wound Dehiscence |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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