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Feracrylum does not Reduce the Incidence of Seroma Formation after Modified Radical Mastectomy

Gatura G, Githaiga J, Kaisha W

School of Medicine, University of Nairobi

Correspondence to: Dr Wyckliffe Kaisha, P.O. Box 368-00202, Nairobi, Kenya. Email: wyksa2000@uonbi.ac.ke

Abstract

Background: Seroma formation, a common complication after mastectomy, may necessitate many hospital visits, carries an increased risk of infection and may delay adjuvant treatment. Many different unsuccessful procedures have been tried to prevent seroma. The aim of this study was to determine whether feracrylum can reduce seroma formation after mastectomy. Methods: A double blinded prospective randomized controlled study, with 2 groups of 24 patients each, was conducted with one exposed to feracryllum and the other a control group.

Results: Seroma rate was 88% in the feracrylum group while it was 38% in the control group (p<0.0001). The mean volume of drainage was less with feracrylum 695ml vs. 1486ml (p<0001). There was significant reduction in the days of drain retention 5.9 vs. 12.8(p<0.0001), and therate of wound related complications 8% vs. 7.1% in the feracrylum group (p<0.0001). Conclusion: Feracrylum does not reduce the incidence of seroma after mastectomy but it reduces the total volume of drainage and the rate of wound complications.

 

Key Words: Seroma, Mastectomy, Breast cancer

Introduction

Breast cancer is the most common malignancy in women worldwide and surgery is an important aspect of treatment (1). Modified radical mastec-tomy (MRM) is associated with numerous com-plications including seroma formation, the most common complication (1,2). Seroma is associated with skin stretching, patient discomfort, infection and prolongation of hospital stay. When it occurs post-operatively, this may require multiple visits for aspiration (3). Multiplicities of techniques have been tried in attempt to control seroma formation following mastectomy. Among them are; shoulder immobilization, use of fibrin sealant, various drain regimens and dead space obliteration with no success. Feracrylum, a coagulant, is an incomplete iron salt of polyacrylic acid. Within a pH range of 2.9 – 4, it forms water insoluble complexes with proteins of various origins including those contained in blood plasma. It has not been used to control seroma after mastectomy though it has been shown to reduce post-operative fluid collection following dental, orthopedic and laparoscopic procedures (4). The aim of this study was to determine whether Feracrylum leads to a reduction in the frequency of seroma formation following mastectomy.

 

Methods

A double blinded prospective randomized controlled trial including all breast cancer patients undergoing modified radical mastectomy at Kenyatta National hospital was conducted between May and September 2010. Patients booked for breast conservation and those with severe co-morbid conditions (hypertension, diabetes and immunosuppression) were excluded. Sample size calculation was done to detect a 40% reduction in the number of patients developing seroma after mastectomy with feracrylum compared to those without use of feracrylum, with a α of 0.05 and a power of 80%. This is because it has been established in previous studies that with use of drains alone there is a 25% reduction of seroma formation (5). It is of clinical relevance if a 40% reduction for those in the study group (65% of the subjects will have a successful outcome). A sample size of 42 patients was arrived at (21 patients per group).

All eligible persons were randomly assigned to two groups by using a computer generated code. The patients and investigators were blinded. A research assistant assigned the patients to either group A or B. Group ‘A’ underwent MRM plus tube