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| Name | Class |
|---|---|
| Asociación De Cirujanos De Mama De Toledo | OTHER |
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Hemopatch is an alternative to reduce morbidity associated with axillary lymphadenectomy surgery, possibly contributing to improved patient management, clinical outcomes, and hospital costs. We propose a multicenter, controlled, and randomized trial to study the efficacy of Hemopatch in reducing serous wound drainage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemopatch Group: | Experimental | Hemopatch + suction drainage |
|
| Control group | Other | No sealant (liquid, gel or patch) + suction drain |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemopatch | Device | HEMOPATCH Sealing Hemostat ("HEMOPATCH") consists of a soft, thin, pliable, flexible pad of collagen derived from bovine dermis, coated with NHS-PEG (pentaerythritol polyethylene glycol ether tetra-succinimidyl glutarate). Due to its flexible structure, the application of HEMOPATCH to the site where hemostasis / sealing is desired is easily controlled. For differentiation, the non-coated side is marked with blue squares using a biocompatible colorant. HEMOPATCH is supplied in the following 3 sizes:
|
| Measure | Description | Time Frame |
|---|---|---|
| Total volume in milliliters (ml) of drainage | Total volume in milliliters (ml) of drainage: To be measured in the hospital every day before discharge, and collected daily after discharge with a follow-up of phone calls or patient diaries during hospital visits until extraction drain. | In the last 24 hours |
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INCLUSION CRITERIA
Preoperative:
Intraoperative:
Postoperative:
- Patients with ≥ 10 axillary nodes removed
EXCLUSION CRITERIA
Preoperative:
Intraoperative:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| María García Ávila, MD | Contact | 638432910 | garciaavilamaria@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Surgery and Digestive System Service | Recruiting | Toledo | 45004 | Spain |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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After axillary node dissection, patients will be randomised to:
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|
| Control group | Other | No sealant (liquid, gel or patch) + suction drain |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D008722 | Methods |