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CompletedNCT04811378Updated Sep 13, 2021

HaemoCerTM Application in Breast Cancer Surgery

An interventional study of HaemoCer in Breast Neoplasm Female and Mastectomy, Segmental, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to female participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-09-13.

Sponsored by Medical University of Vienna · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 3 years 5 months after the study started (first participant enrolled Oct 2017, registered Mar 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
136
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
Female
01

Study 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).

02

Conditions studied

  • Breast Neoplasm Female
  • Mastectomy, Segmental

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 136 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

Patients with previous breast-conserving surgery on the same site

-

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
136 participants (actual)

Study arms

  • Active comparator
    HaemoCer

    Other: HaemoCer

  • No intervention
    No HaemoCer

Interventions

  • OtherHaemoCer

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

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What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • Medical University of Vienna
    Vienna, 1090, Austria
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04811378
Lead sponsor
Medical University of Vienna
Responsible party
Christian Singer (Univ.-Prof. Dr.med.univ. MPH, Medical University of Vienna) — Principal investigator
First posted
Mar 23, 2021
Start date
Oct 5, 2017
Primary completion
Mar 1, 2021
Completion
Mar 1, 2021
Last update
Sep 13, 2021

Study contacts

Christian Singer, Prof.
principal investigator · Medical University of Vienna

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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