NCT04811378

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
Last Updated

September 13, 2021

Status Verified

September 1, 2021

Enrollment Period

3.4 years

First QC Date

March 19, 2021

Last Update Submit

September 3, 2021

Conditions

Breast Neoplasm FemaleMastectomy, Segmental

Outcome Measures

Primary Outcomes (2)

  • Total volume of postoperative drained fluid (per breast)

    7 days

  • Number of days until drain removal (n)

    7 days

Secondary Outcomes (2)

  • Total volume of postoperative drained fluid from the axillary fossa in case of axilla surgery (sentinel lymphonodectomy, axillary dissection)

    7 days

  • Rate of immediate postoperative infection on the breast surgery site

    7 days

Study Arms (2)

HaemoCer

ACTIVE COMPARATOR
Other: HaemoCer

No HaemoCer

NO INTERVENTION

Interventions

HaemoCerOTHER

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

HaemoCer

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with previous breast-conserving surgery on the same site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Study Officials

  • Christian Singer, Prof.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ.-Prof. Dr.med.univ. MPH

Study Record Dates

First Submitted

March 19, 2021

First Posted

March 23, 2021

Study Start

October 5, 2017

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

September 13, 2021

Record last verified: 2021-09

Locations

AU(1)