Evaluating Hemopatch in Reducing Seroma Related Complications Following Axillary Lymph Node Dissection: a Pilot Study
NCT04185480 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62
Last updated 2021-09-24
Summary
To evaluate if the use of Hemopatch in axillary lymph node dissection shows potential in reducing clinically significant seroma and seroma related complications, which might serve as a basis for a randomized controlled trial.
Conditions
- Axillary Lymph Node Dissection
- ALND
- Axillary Clearance
- Seroma
Interventions
- DEVICE
-
Hemopatch
Before closure of the wound this hemostatic sealant (Hemopatch), a pad of collagen derived from bovine dermis will be applied in the axilla
Sponsors & Collaborators
-
Zuyderland Medisch Centrum
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-06-16
- Primary Completion
- 2021-06-01
- Completion
- 2021-06-01
Countries
- Netherlands
Study Locations
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