HaemoCerTM Application in Breast Cancer Surgery | NCT04811378

Studies
HaemoCerTM Application in Breast Cancer Surgery

NCT04811378

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Sep 13, 2021Actual

Enrollment

136Actual

Phase

Not Applicable

Conditions

Breast Neoplasm Female
Mastectomy, Segmental

Interventions

HaemoCer

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 5, 2017Actual

Primary Completion Date

Mar 1, 2021Actual

Completion Date

Mar 1, 2021Actual

First Submitted Date

Mar 19, 2021

First Submission Date that Met QC Criteria

Mar 19, 2021

First Posted Date

Mar 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 3, 2021

Last Update Posted Date

Sep 13, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christian Singer, Univ.-Prof. Dr.med.univ. MPH, Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

136Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HaemoCer	Active Comparator		Other: HaemoCer
No HaemoCer	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HaemoCer	Other	Randomized application of 3g haemostatic powder (HaemoCer) in the wound site during breast-conserving surgery.	HaemoCer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total volume of postoperative drained fluid (per breast)		7 days
Number of days until drain removal (n)		7 days

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian Singer, Prof.	Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna		Vienna		1090	Austria