HaemoCerTM Application in Breast Cancer Surgery

Breast Neoplasm Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04811378
• Other study ID #: 1178/2017
• Status: Completed
• Phase: N/A
• Start date: October 5, 2017
• Est. completion date: March 1, 2021

Study information

• Verified date: September 2021
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

-

Related Conditions & MeSH terms

• Breast Neoplasm Female
• Breast Neoplasms
• Mastectomy, Segmental

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total volume of postoperative drained fluid (per breast)		7 days
Primary	Number of days until drain removal (n)		7 days
Secondary	Total volume of postoperative drained fluid from the axillary fossa in case of axilla surgery (sentinel lymphonodectomy, axillary dissection)		7 days
Secondary	Rate of immediate postoperative infection on the breast surgery site		7 days