Seroma Reduction and Drain Free Mastectomy

Breast Cancer Clinical Trial

— SARA  

Official title:

Seroma Reduction and Drain Free Mastectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04035590
• Other study ID #: METCZ2019016
• Status: Recruiting
• Phase: N/A
• Start date: June 26, 2020
• Est. completion date: December 2023

Study information

• Verified date: July 2023
• Source: Zuyderland Medisch Centrum
• Contact: James van Bastelaar, MD, PhD
• Phone: +31884591870
• Email: j.vanbastelaar[@]zuyderland.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Seroma
• Wound Complication

Intervention

Procedure:
• No drain
Mastectomy with flap fixation without low vacuum drainage
• With drain
Mastectomy with flap fixation with low vacuum drainage

Locations

Country	Name	City	State
Netherlands	Zuyderland Medisch Centrum	Sittard	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Zuyderland Medisch Centrum

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Cosmesis	Cosmesis rated by the patient using the numeric rating scale (NRS) every planned outpatient clinic visit.	During the first six postoperative months
Secondary	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
Secondary	The number of outpatient department visits	The number of outpatient department visits	During the first six months postoperative.
Secondary	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