HaemoCerTM Application in Breast Cancer Surgery

Medical University of Vienna

Status: Completed

Conditions: Breast Neoplasm Female; Mastectomy, Segmental

Treatments: Other: HaemoCer

Study type: Interventional

Funder types: Other

Identifiers

NCT04811378

1178/2017

Details and patient eligibility

About

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).

Enrollment: 136 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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136 participants in 2 patient groups

HaemoCer

Active Comparator group

Treatment:

Other: HaemoCer

No HaemoCer

No Intervention group