Seroma Reduction and Drain Free Mastectomy

Study Overview
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Brief Summary
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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
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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): Mastectomy with flap fixation using sutures with closed suction drainage 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.

Official Title
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Seroma Reduction and Drain Free Mastectomy

Conditions
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Breast Cancer, Seroma, Wound Complication

Intervention / Treatment
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* Procedure: No drain
* Procedure: With drain


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mastectomy, Drain