Seroma Reduction and Drain Free Mastectomy (SARA)

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 Overview

• Status: Recruiting
• Conditions: Breast Cancer; Seroma; Wound Complication
• Intervention / Treatment: Procedure: With drain; Procedure: No drain

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.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: James van Bastelaar, MD, PhD; Phone Number: +31884591870; Email: j.vanbastelaar@zuyderland.nl
• Study Contact Backup: Name: Merel Spiekerman van Weezelenburg, MD; Phone Number: +31884591870; Email: m.spiekermanvanweezelenburg@zuyderland.nl

Study Locations

• Netherlands
  • Limburg
    • Sittard, Limburg, Netherlands, 6162 BG
      • Recruiting
      • Zuyderland Medisch Centrum
      • Contact: James van Bastelaar, MD; Phone Number: +31641227350; Email: j.vanbastelaar@zuyderland.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: With drain; Patients undergo mastectomy with flap fixation and low vacuum drainage.	Procedure: With drain; Mastectomy with flap fixation with low vacuum drainage
Experimental: No drain; Patients undergo mastectomy with flap fixation and low vacuum drainage is omitted.	Procedure: No drain; Mastectomy with flap fixation without low vacuum drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroma aspiration of clinically significant seroma	Proportion of patients undergoing seroma aspiration of clinically significant seroma Clinically significant seroma defined as: Wound healing is at risk due to seroma (wound break down, seroma leakage, necrosis); There is discomfort or pain caused by large amounts of seroma, characterised by tenseness of the skin.; 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of invasive interventions related to seroma or wound healing	Number of invasive interventions related to seroma or wound healing defined as: every aspiration of clinically significant seroma, incision and drainage of abscess or infected seroma and/or operative debriding of the wound.	During first six months post-operative
Surgical site infection (SSI) rate	Surgical site infection (SSI) rate, defined as redness, pain, heat or swelling at the site of the incision or by the drainage of pus. Infection rate will be measured by A) the need for antibiotics, B) seroma aspiration due to infection or C) surgical drainage.	During the first six postoperative months
Cosmesis	Cosmesis rated by the patient using the numeric rating scale (NRS) every planned outpatient clinic visit.	During the first six postoperative months
Quality of life measured using the SF-12 Health Survey	Quality of life measured using the SF-12 Health Survey. Resulting in 2 scores: the Mental Component Summary (MCS) and the Physical Component Summary (PCS). Both range between values of 0-100 with a score of 50 representing values of a standard population	During the first six postoperative months
The number of outpatient department visits	The number of outpatient department visits	During the first six months postoperative.
Experienced pain: NRS	Experienced wound pain and pain at the drain site by the patient using the NRS with a scale range from 0-10	During the first six months postoperative

Collaborators and Investigators

• Sponsor: Zuyderland Medisch Centrum

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2020
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: July 24, 2019
• First Submitted That Met QC Criteria: July 26, 2019
• First Posted (Actual): July 29, 2019

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Mastectomy; Drain
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Seroma
• Other Study ID Numbers: METCZ2019016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No