Back to resultsHaemoCerTM Application in Breast Cancer Surgery
Primary Purpose
Breast Neoplasm Female, Mastectomy, Segmental
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
HaemoCer
Sponsored by
About this trial
This is an interventional prevention trial for Breast Neoplasm Female
Eligibility 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
-
Sites / Locations
- Medical University of Vienna
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
HaemoCer
No HaemoCer
Arm Description
Outcomes
Primary Outcome Measures
Total volume of postoperative drained fluid (per breast)
Number of days until drain removal (n)
Secondary Outcome Measures
Total volume of postoperative drained fluid from the axillary fossa in case of axilla surgery (sentinel lymphonodectomy, axillary dissection)
Rate of immediate postoperative infection on the breast surgery site
Full Information
NCT ID
NCT04811378
First Posted
March 19, 2021
Last Updated
September 3, 2021
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT04811378
Brief Title
HaemoCerTM Application in Breast Cancer Surgery
Official Title
Randomised Controlled Trial: HaemoCerTM Versus no HaemoCerTM in Breast Cancer Surgery to Reduce Postoperative Drainage Output
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 5, 2017 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm Female, Mastectomy, Segmental
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HaemoCer
Arm Type
Active Comparator
Arm Title
No HaemoCer
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
HaemoCer
Intervention Description
Randomized application of 3g haemostatic powder (HaemoCer) in the wound site during breast-conserving surgery.
Primary Outcome Measure Information:
Title
Total volume of postoperative drained fluid (per breast)
Time Frame
7 days
Title
Number of days until drain removal (n)
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Total volume of postoperative drained fluid from the axillary fossa in case of axilla surgery (sentinel lymphonodectomy, axillary dissection)
Time Frame
7 days
Title
Rate of immediate postoperative infection on the breast surgery site
Time Frame
7 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Singer, Prof.
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
HaemoCerTM Application in Breast Cancer Surgery
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