Status:

UNKNOWN

Seroma Reduction and Drain Free Mastectomy

Lead Sponsor:

Zuyderland Medisch Centrum

Conditions:

Breast Cancer

Seroma

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief Summary

To prove that omitting drains after mastectomy and flap fixation does not contribute to higher incidence of seroma formation and therefore reducing patient disutility such as seroma aspirations and vi...

Detailed Description

Rationale: Seroma formation, a collection of serous fluid containing blood plasma and/or lymph fluid, is a common complication in breast cancer surgery and can lead to delayed wound healing, infectio...

Eligibility Criteria

Inclusion

  • Older than 18 years
  • Female sex
  • Indication for mastectomy

Exclusion

  • Patients undergoing breast conserving therapy
  • Patients undergoing modified radical mastectomy
  • Patients undergoing direct breast reconstruction
  • Unable to comprehend implications and extent of study and sign for informed consent
  • Patients with radiation therapy of unilateral breast in previous history

Key Trial Info

Start Date :

June 26 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2023

Estimated Enrollment :

250 Patients enrolled

Trial Details

Trial ID

NCT04035590

Start Date

June 26 2020

End Date

December 1 2023

Last Update

July 7 2023

Active Locations (1)

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1

Zuyderland Medisch Centrum

Sittard, Limburg, Netherlands, 6162 BG