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HaemoCerTM Application in Breast Cancer Surgery

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ClinicalTrials.gov Identifier: NCT04811378
Recruitment Status : Completed
First Posted : March 23, 2021
Last Update Posted : September 13, 2021
Sponsor:
Information provided by (Responsible Party):
Christian Singer, Medical University of Vienna

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Breast Neoplasm Female Mastectomy, Segmental Other: HaemoCer Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomised Controlled Trial: HaemoCerTM Versus no HaemoCerTM in Breast Cancer Surgery to Reduce Postoperative Drainage Output
Actual Study Start Date : October 5, 2017
Actual Primary Completion Date : March 1, 2021
Actual Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: HaemoCer Other: HaemoCer
Randomized application of 3g haemostatic powder (HaemoCer) in the wound site during breast-conserving surgery.
No Intervention: No HaemoCer


Outcome Measures
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Primary Outcome Measures :
  1. Total volume of postoperative drained fluid (per breast) [ Time Frame: 7 days ]
  2. Number of days until drain removal (n) [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Total volume of postoperative drained fluid from the axillary fossa in case of axilla surgery (sentinel lymphonodectomy, axillary dissection) [ Time Frame: 7 days ]
  2. Rate of immediate postoperative infection on the breast surgery site [ Time Frame: 7 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04811378


Locations
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Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Christian Singer, Prof. Medical University of Vienna
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Christian Singer, Univ.-Prof. Dr.med.univ. MPH, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT04811378    
Other Study ID Numbers: 1178/2017
First Posted: March 23, 2021    Key Record Dates
Last Update Posted: September 13, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases