Seroma Reduction and Drain Free Mastectomy

NCT04035590 | Unknown DMC

• 1 other identifier: METCZ2019016
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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 visits to the outpatient clinic, as well as reducing seroma related wound complications.

Conditions

Breast Cancer; Seroma; Wound Complication

Keywords

Mastectomy; Drain

Outcome Measures

Primary Outcomes (1)

• Seroma aspiration of clinically significant seroma

  Proportion of patients undergoing seroma aspiration of clinically significant seroma Clinically significant seroma defined as: 1. Wound healing is at risk due to seroma (wound break down, seroma leakage, necrosis) 2. There is discomfort or pain caused by large amounts of seroma, characterised by tenseness of the skin. 3. There is contaminated/ infected seroma and aspiration is necessary to treat infection. All patients that undergo seroma aspiration due to infection will also be treated with a one week course of Augmentin 625 mg 3 times daily.

  During first six months post-operative

Secondary Outcomes (6)

• Number of invasive interventions related to seroma or wound healing

  During first six months post-operative

• Surgical site infection (SSI) rate

  During the first six postoperative months

• Cosmesis

  During the first six postoperative months

• Quality of life measured using the SF-12 Health Survey

  During the first six postoperative months

• The number of outpatient department visits

  During the first six months postoperative.

Study Arms (2)

With drain

ACTIVE COMPARATOR

Patients undergo mastectomy with flap fixation and low vacuum drainage.

Procedure: With drain

No drain

EXPERIMENTAL

Patients undergo mastectomy with flap fixation and low vacuum drainage is omitted.

Procedure: No drain

Interventions

No drain PROCEDURE

Mastectomy with flap fixation without low vacuum drainage

No drain

With drain PROCEDURE

Mastectomy with flap fixation with low vacuum drainage

With drain

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

Study Sites (1)

Zuyderland Medisch Centrum

Sittard, Limburg, 6162 BG, Netherlands

RECRUITING

Related Publications (1)

• de Rooij L, van Kuijk SMJ, van Haaren ERM, Janssen A, Vissers YLJ, Beets GL, van Bastelaar J. A single-center, randomized, non-inferiority study evaluating seroma formation after mastectomy combined with flap fixation with or without suction drainage: protocol for the Seroma reduction and drAin fRee mAstectomy (SARA) trial. BMC Cancer. 2020 Aug 7;20(1):735. doi: 10.1186/s12885-020-07242-0.

  PMID: 32767988 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Seroma

Interventions

Drainage

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Central Study Contacts

James van Bastelaar, MD, PhD

CONTACT

+31884591870; j.vanbastelaar@zuyderland.nl

Merel Spiekerman van Weezelenburg, MD

CONTACT

+31884591870; m.spiekermanvanweezelenburg@zuyderland.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon, Principal Investigator, MD, PhD

Model Details: Study design is a randomized controlled trial. All patients are \> 18 years and will be enrolled after obtaining informed consent in the surgical out patient clinics of Zuyderland Medical Center Sittard. All patients have an indication to undergo mastectomy due to invasive breast cancer or DCIS. Follow up will be performed until 6 months after surgery. Patients will be evaluated in the out patient clinic 1 week, 6 weeks, 3 months and 6 months.

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 29, 2019
• Study Start: June 26, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)