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Hemopatch Versus Axillary Drainage After Axillary Lymphadenectomy

NCT04487561 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2023-02-17

No results posted yet for this study

Summary

Aspirative drainage continues to be the "gold standard" for the management of this post-surgical complication, even though it can lead to complications such as obstruction of the drainage, peritubal leakage of the seroma, etc. This may result in pain and reduction in mobility of the affected arm.

Based on our positive clinical outcomes and the fact that there is not any published data available in the literature regarding this use of the patch, the investigators propose a multicentric, randomized controlled clinical trial, with the objective of comparing the Hemopatch® with the usual technique used (aspirative drainage) in terms of efficacy and safety.

Hypothesis: Placing a Hemopatch ® instead of an aspirative drainage in women after undergoing axillary lymph node dissection during breast cancer surgery may reduce the appearance of seroma and consequently the need for a puncture, as well as the complications related to aspirative drainage.

Conditions

  • Breast Cancer
  • Breast-conserving Surgery
  • Axillary Lymph Node Dissection

Interventions

DEVICE

hemopatch

The patient will be randomized after performing the lymphadenectomy, according to a table of random numbers performed in excel kuytools, then a compression bandage will be performed on all the patients and it will be controlled 24 hours postoperatively, the subsequent control will be weekly until the drain is removed. and / or the disappearance of the seroma

PROCEDURE

Aspirative drainage

The patient will be randomized after performing the lymphadenectomy, according to a table of random numbers performed in excel kuytools, then a compression bandage will be performed on all the patients and it will be controlled 24 hours postoperatively, the subsequent control will be weekly until the drain is removed. and / or the disappearance of the seroma

Sponsors & Collaborators

  • Fundación para la Investigación del Hospital Clínico de Valencia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2023-02-14
Completion
2023-02-14

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04487561 on ClinicalTrials.gov