HaemoCerTM Application in Breast Cancer Surgery

Not Applicable

Completed

• Conditions: Mastectomy, Segmental; Breast Neoplasm Female
• Interventions: Other: HaemoCer

• Registration Number: NCT04811378
• Lead Sponsor: Medical University of Vienna

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-05
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-19
• Study First Posted: 2021-03-23
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-03
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 136

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

Read More

Exclusion Criteria

Patients with previous breast-conserving surgery on the same site

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HaemoCer	HaemoCer	-

Primary Outcome Measures

Name	Time	Method
Number of days until drain removal (n)	7 days
Total volume of postoperative drained fluid (per breast)	7 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria