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OpenTrials
Completed

NCT Number: NCT04811378

HaemoCerTM Application in Breast Cancer Surgery

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).

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Key information

Conditions

Breast Neoplasm Female Mastectomy, Segmental

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

HaemoCer

Other

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

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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Randomised Controlled Trial: HaemoCerTM Versus no HaemoCerTM in Breast Cancer Surgery to Reduce Postoperative Drainage Output

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 23, 2021
Registry last updated
Sep 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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