HaemoCerTM Application in Breast Cancer Surgery

NCT ID: NCT04811378

Last Updated: 2021-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-05

Study Completion Date

2021-03-01

Brief Summary

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HaemoCer is a hemostatic agent to control bleedings during surgical procedures by accelerating natural hemostasis and is frequently applied during breast conserving surgery in women with breast cancer. There is however no adequate data available on the efficacy of HaemoCer regarding seroma formation or drainage output. The objective of this study is to investigate whether the intraoperative application of haemostatic powder (HaemoCer) in breast-conserving surgery in breast cancer patients reduces the postoperative drainage output and number of days until drain removal (number of hospitalization days).

Detailed Description

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Conditions

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Breast Neoplasm Female Mastectomy, Segmental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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HaemoCer

Group Type ACTIVE_COMPARATOR

HaemoCer

Intervention Type OTHER

Randomized application of 3g haemostatic powder (HaemoCer) in the wound site during breast-conserving surgery.

No HaemoCer

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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HaemoCer

Randomized application of 3g haemostatic powder (HaemoCer) in the wound site during breast-conserving surgery.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with breast cancer undergoing breast-conserving surgery
* No previous breast-conserving surgery on the same site
* ≥ 18 years age
* no current pregnancy
* Informed consent

Exclusion Criteria

Patients with previous breast-conserving surgery on the same site

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Christian Singer

Univ.-Prof. Dr.med.univ. MPH

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian Singer, Prof.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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1178/2017

Identifier Type: -

Identifier Source: org_study_id

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