Seroma Reduction and Drain Free Mastectomy

NCT ID: NCT04035590

Last Updated: 2023-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-26
• Study Completion Date: 2023-12-31

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.

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, infection, skin flap necrosis, patient discomfort and repeated visits to the outpatient clinic and therefore extensive research has been done to further elucidate the pathophysiology and prevention of seroma formation. Promising results have resulted from studies focusing on flap fixation in order to reduce the incidence of seroma and seroma aspirations. Mastectomy with flap fixation is becoming standard practice and is currently combined with closed-suction drainage. Closed-suction drainage is considered gold standard for reducing seroma formation after breast cancer surgery. However, evidence shows that closed-suction drainage is insufficient in preventing seroma formation. One might wonder if there is still a place for closed-suction drainage after mastectomy if flap fixation is performed. The promising results in flap fixation could exclude drainage systems in breast cancer surgery. However, the available data consist of small case series and therefore a large randomized controlled trial is needed for it to be widely implemented.

To our knowledge, no randomized controlled trial has been conducted comparing flap fixation with and without closed-suction drainage with seroma aspiration as the primary outcome.

The investigators hypothesize that flap fixation with closed suction drainage does not cause a significant lower incidence of seroma aspirations, when compared to flap fixation alone. The investigators also expect that patients without drainage will experience significantly less discomfort and comparable rates of surgical site infections.

Objective: 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.

Study design: Prospective randomized controlled trial

Study population: Female patients > 18 years diagnosed with invasive breast cancer or DCIS (ductal carcinoma in situ) with an indication to perform mastectomy

Intervention (if applicable):

1. Mastectomy with flap fixation using sutures with closed suction drainage

2. Mastectomy with flap fixation using sutures without closed suction drainage

Main study parameters/endpoints:

Patients undergoing seroma aspiration (clinically significant seroma (CSS)).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

Patients will be informed about the study before inclusion in the outpatient clinic. Informed consent will be obtained in the outpatient clinic a week after patients were initially informed. Postoperative check-ups will be done more frequently. Standard postoperative check-ups are planned at 2 weeks and 3 months. Additional study postoperative check-ups: 6 weeks, 6 months. Therefore, patients will be required to undergo two additional check-ups.

During out patients' visits, patients will hand in a questionnaire scale regarding cosmesis, pain and quality of life.

Patients will be clinically examined as they usually would be.

Conditions

Breast Cancer; Seroma; Wound Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

With drain

Patients undergo mastectomy with flap fixation and low vacuum drainage.

Group Type: ACTIVE_COMPARATOR

With drain

Intervention Type: PROCEDURE

Mastectomy with flap fixation with low vacuum drainage

No drain

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

Group Type: EXPERIMENTAL

No drain

Intervention Type: PROCEDURE

Mastectomy with flap fixation without low vacuum drainage

Interventions

No drain

Mastectomy with flap fixation without low vacuum drainage

Intervention Type: PROCEDURE

With drain

Mastectomy with flap fixation with low vacuum drainage

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zuyderland Medisch Centrum

OTHER

Sponsor Role: lead

Responsible Party

James van Bastelaar

Surgeon, Principal Investigator, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zuyderland Medisch Centrum

Sittard, Limburg, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

James van Bastelaar, MD, PhD

Role: CONTACT

j.vanbastelaar@zuyderland.nl

+31884591870

Merel Spiekerman van Weezelenburg, MD

Role: CONTACT

m.spiekermanvanweezelenburg@zuyderland.nl

+31884591870

Facility Contacts

James van Bastelaar, MD

Role: primary

j.vanbastelaar@zuyderland.nl

+31641227350

References

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.

Reference Type: DERIVED

PMID: 32767988 (View on PubMed)

Other Identifiers

METCZ2019016

Identifier Type: -

Identifier Source: org_study_id