Abstract
Formation of seroma most frequently occurs after mastectomy and axillary surgery. This study is intended at creating data on whether flap fixation has any role in reducing the seroma formation in patients undergoing the modified radical mastectomy. A prospective comparative study was conducted among 61 patients scheduled for modified radical mastectomy from 1st of January 2017 to 31st of December 2017. Patients were divided into two groups. In the flap fixation group (N = 30), the skin flaps were sutured to the pectoral muscle with Vicryl 3–0 sutures, and in the control group (N = 31), the wound was closed in the conventional methods at the edges. Closed suction drain was used in both groups. Flap fixation group showed a significantly lower frequency of seroma formation compared with the control group. In the flap fixation group, the drain was removed earlier compared with the control group. Mean value of the total amount of fluid drained for the study group was significantly lower than that of control. Flap fixation is a surgical technique which appears to reduce the total volume of fluid drained, the development of seroma, and the need for seroma aspirations.
Keywords: Modified radical mastectomy, Seroma, Flap fixation, Breast cancer
Introduction
The incidence of breast cancer is on the increase in India, and an increasing number of women are undergoing modified radical mastectomy (MRM) as the treatment for breast cancer [1, 2]. Mastectomy is associated with few significant complications. The most common complication is wound seroma, a collection of serous fluid that contains plasma and or lymph fluid, with a reported incidence rate of 3% to 85% [3]. Pathogenesis of seroma is not well understood. Several factors are held responsible for seroma formation.
The type of breast surgery performed is an important predictor of seroma formation whereas the age of the patient, axillary nodal status, tumor size, and the use of neoadjuvant chemotherapy were not. The use of electrocautery has been demonstrated to increase seroma formation following mastectomy; however, no other surgical devices have proven to be superior in seroma reduction [4].
This study is intended at creating data on whether flap fixation has any role in reducing the seroma formation in patients undergoing modified radical mastectomy in a tertiary care teaching hospital in Karnataka, India.
Methodology
A prospective comparative study was conducted among 61 patients with histologically proven cases of female breast cancer patients (with stage I-III disease) who are admitted for modified radical mastectomy in the Dept. of General Surgery, Krishna Rajendra Hospital, Mysore Medical College and Research Institute, Mysore, Karnataka from 1st of January 2017 to 31st of December 2017 (1 year). Patients on anticoagulant treatment, patients with abnormal coagulation profile, patients with body mass index (BMI) greater than 30 kg/m2 or less than 18.5 kg/m2, patients with uncontrolled diabetes mellitus, patients with uncontrolled hypertension (systolic BP > 150, diastolic BP > 100), patients with chronic liver disease, and patients who had any prior surgery on the axillary lymphatic system were excluded.
After being inducted into the study population, the patient was subjected to a detailed clinical examination, followed by radiological examination (mammogram/ultrasonogram/sonomammogram). All data—including clinical, demographic and neoadjuvant treatment—were collected. Patients were randomly grouped into two, based on the type of closure of modified radical mastectomy: Group A (control group, 31 patients), in which wound closure was done by the conventional method at edges with closed suction drainage, and Group B (flap fixation group, 30patients), in which wound closure was done with flap fixation with closed suction drainage. After mastectomy (MRM), the skin flaps were sutured to the pectoral muscle with Vicryl 3–0 sutures. Sutures were placed at 3 cm intervals in two or three rows depending upon the extent of the flaps. Axilla was obliterated by suturing its lateral wall to the fascia of the serratus anterior muscle and medial axillary wall (Figs. 1 and 2). After surgery, specimens were subjected to detailed histopathological evaluation, and all pathological parameters were recorded. Amount of drained fluid was recorded daily. Drains were removed when 24-h effluent becomes < 30 ml. Two weeks after drain removal, local chest wall examination was done, and an ultrasound scan over the flaps and axilla was done if necessary to rule out any collections. Total amount and duration of drained fluid and formation of seroma were recorded.
Fig. 1.
Image showing the technique of flap fixation to the underlying pectoralis major muscle after the modified radical mastectomy
Fig. 2.
Image showing flap fixation to chest wall after completing one layer of interrupted sutures using Vicryl 3–0
Data were entered in Microsoft Excel and analyzed using Epi info 7 Centers for Disease Control and Prevention (CDC) (Atlanta, GA, USA). Continuous variables were presented as means with standard deviations; categorical variables were presented as percentages. Continuous variables were compared between study groups with Student T tests. Categorical variables were compared between study groups with chi-squared tests. p < 0.05, is considered as evidence of statistical significance.
Results
Sixty-one patients were included: 30 in the flap fixation group and 31 in the control group. Mean age of the study population was 48.89 years. General characteristics of the study population are shown in Tables 1 and 2. Tumor characteristics and demographics of patients of both the groups are compared and summarized in Tables 3 and 4. There were no significant differences noted between the two groups for age, menopausal status, grade of the tumor, nodal status, tumor size, side affected, stage of the tumor, and the presence of diabetes and neoadjuvant chemotherapy (Tables 3 and 4).
Table 1.
General characteristics of the study population (for quantitative variables)
| Variable | Mean | SD | Minimum | Maximum |
|---|---|---|---|---|
| Age (years) | 48.89 | 9.92 | 30 | 76 |
| Height (m) | 1.5 | 0.07 | 1.31 | 1.68 |
| Weight (kg) | 55 | 1.07 | 35 | 91 |
| BMI (kg/m2) | 24.27 | 4.4 | 18.46 | 33.63 |
| Tumor size (cm) | 4.28 | 2.45 | 1.8 | 11 |
| No. of drain (in days) | 5.34 | 1.15 | 4 | 9 |
| Total drain (ml) | 559.9 | 177.76 | 330 | 1100 |
Table 2.
General characteristics of the study population (for qualitative variables)
| Variable | N | % |
|---|---|---|
| Age group | ||
| 20–30 | 1 | 1.6 |
| 31–40 | 14 | 23 |
| 41–50 | 23 | 37.7 |
| 51–60 | 16 | 26.2 |
| 61–70 | 6 | 9.8 |
| 71–80 | 1 | 1.6 |
| Menopausal | ||
| Pre-meno | 28 | 45.9 |
| Post-meno | 33 | 54.1 |
| Side | ||
| Right | 35 | 57.4 |
| Left | 26 | 42.6 |
| Nodal status | ||
| LN-negative | 11 | 18 |
| 1–3 LN+ | 21 | 34.4 |
| > 3LN+ | 29 | 47.5 |
| Stage | ||
| 1 | 3 | 4.9 |
| 2A | 12 | 19.7 |
| 2B | 28 | 45.9 |
| 3A | 10 | 16.4 |
| 3B | 7 | 11.5 |
| 3C | 1 | 1.6 |
| Neoadjuvant | ||
| No | 50 | 82 |
| Yes | 11 | 18 |
| Grade | ||
| 1 | 3 | 4.9 |
| 2 | 34 | 55.7 |
| 3 | 24 | 39.3 |
| Diabetes | ||
| No | 51 | 83.6 |
| Yes | 10 | 16.4 |
| Hematoma | ||
| No | 60 | 98.4 |
| Yes | 1 | 1.6 |
| Surgical site infection | ||
| No | 54 | 88.5 |
| Yes | 7 | 11.5 |
| Partial flap necrosis | ||
| No | 57 | 93.4 |
| Yes | 4 | 6.6 |
Table 3.
Comparison of flap fixation group with control group
| Flap fixation group (N = 30) | Control group (N = 31) | ||
|---|---|---|---|
| Variable | Mean ± SD | Mean ± SD | p value |
| Age (years) | 50.21 ± 10.78 | 47.81 ± 9.06 | 0.393 |
| Height (m) | 1.51 ± 0.07 | 1.49 ± 0.06 | 0.334 |
| Weight (kg) | 55.01 ± 12.41 | 55.21 ± 8.89 | 0.991 |
| BMI (kg/m2) | 23.97 ± 5.06 | 24.56 ± 3.72 | 0.605 |
| Tumor size (cm) | 4.37 ± 2.69 | 4.18 ± 2.33 | 0.781 |
| Duration of surgery (minutes) | 102 ± 20 | 98 ± 24 | 0.810 |
| Number of lymph nodes removed | 16.9 ± 2.8 | 19.3 ± 3.7 | 0.231 |
| No. of drain (in days) | 4.60 ± 0.62 | 6.06 ± 1.09 | < 0.001 |
| Total drain (ml) | 449.67 ± 76.04 | 666.67 ± 183.55 | < 0.001 |
Table 4.
Comparison of flap fixation group with control group
| Flap fixation group (N = 30) | Control group (N = 31) | |||
|---|---|---|---|---|
| N (%) | N (%) | p value | OR[CI] | |
| Age group | 0.804 | |||
| 20–30 | 1 (3.3) | 0 | ||
| 31–40 | 6 (20) | 8 (25.8) | ||
| 41–50 | 11 (36.7) | 12 (38.7) | ||
| 51–60 | 8 (26.7) | 8 (25.8) | ||
| 61–70 | 3 (10) | 3 (9.7) | ||
| 71–80 | 1 (3.3) | 0 | ||
| Menopausal | 0.692 | 0.82 (0.28–2.24) | ||
| Pre-meno | 13 (43.3) | 15 (48.4) | ||
| Post-meno | 17 (56.7) | 16 (51.6) | ||
| Side | 0.96 | 0.42 (0.15–1.18) | ||
| Right | 14 (46.7) | 21 (67.7) | ||
| Left | 16 (53.3) | 10 (32.3) | ||
| Nodal status | 0.316 | |||
| LN-negative | 4 (13.4) | 7 (22.6) | ||
| 1–3 LN+ | 13 (43.3) | 8 (25.8) | ||
| > 3LN+ | 13 (43.3) | 16 (51.6) | ||
| Stage | 0.494 | |||
| 1 | 2 (6.7) | 1 (3.2) | ||
| 2A | 4 (13.3) | 8 (25.8) | ||
| 2B | 14 (46.7) | 14 (45.2) | ||
| 3A | 7 (23.3) | 3 (9.7) | ||
| 3B | 3 (10) | 4 (12.9) | ||
| 3C | 0 | 1 (3.2) | ||
| Neoadjuvant | 0.694 | 0.77 (0.21–2.81) | ||
| No | 24 (80) | 26 (83.9) | ||
| Yes | 6 (20) | 5 (16.1) | ||
| Grade | o.740 | |||
| 1 | 1 (3.3) | 2 (6.5) | ||
| 2 | 16 (53.3) | 18 (58.1) | ||
| 3 | 13 (43.3) | 11 (35.4) | ||
| Diabetes | ||||
| No | 26 (86.7) | 25 (80.6) | 0.525 | 1.56 (0.393–6.12) |
| Yes | 4 (13.3) | 6 (19.4) | ||
In the flap fixation group, the drain was removed earlier compared with the control group (4.6 days vs 6 days). Mean value of the total amount of fluid drained for the study group was much lesser than that of control (449 ml vs 666 ml). Both the number of days with the drain (p < 0.001) and the amount of fluid drained (p < 0.001) showed statistically significant association with the flap fixation technique. Flap fixation group showed a significantly lower frequency of seroma formation compared with the control group (26.7 vs 54.8 clinically and 46.7 vs 67.7 radiological).
Complications rates (hematoma, surgical site infection, and partial flap necrosis) were less in the study group as compared with the control. There was no significant difference in patients developing surgical site infection (SSI) and flap necrosis between the two groups (Table 5). Multiple seroma aspiration was performed in 8/30 (26.6%) patients in the flap fixation group as opposed to 14/31 (45.2%) patients in the control group (p = 0.016).
Table 5.
Frequency of seroma and complications in the two studied groups
| Flap fixation group (30) | Control group (31) | p value | |
|---|---|---|---|
| Seroma (clinical) | 0.039 | ||
| No seroma | 22 (73.3) | 14 (45.2) | |
| Seroma | 8 (26.7) | 17 (54.8) | |
| Seroma (radiological) | 0.044 | ||
| No seroma | 16 (53.3) | 10 (32.3) | |
| Seroma | 14 (46.7) | 21 (67.7) | |
| Complications | |||
| Hematoma | 0.305 | ||
| No | 29 (96.7) | 31 (100) | |
| Yes | 1 (3.3) | 0 | |
| Surgical site infection | 0.246 | ||
| No | 28 (92.9) | 26 (83.9) | |
| Yes | 2 (7.1) | 5 (16.1) | |
| Partial flap necrosis | 0.317 | ||
| No | 29 (96.7) | 30 (96.8) | |
| Yes | 1 (3.3) | 1 (3.2) | |
| Seroma requiring aspiration | 0.016 | ||
| No | 22 (73.4) | 17 (54.8) | |
| Yes | 8 (26.6) | 14 (45.2) | |
Discussion
The mean age at presentation of female breast carcinoma in the present study is 49 years which is a decade earlier compared with patients from West. The average age at diagnosis of breast carcinoma in the USA is 61 years. It is to be noted that other studies from India also have reported similar mean age at presentation [1, 3, 5]. The exact reason for the younger age of onset of breast cancer in Indian population remains unknown, though it has variously been attributed to race, genetic composition, and the environment. Among the study population, 45.9% is in the premenopausal age group. The exact reason for the younger age of onset of breast cancer in Indian community remains unknown. Most patients presented in stage IIB disease; they account for about 45.9% of the study population. Patients with stage I disease were only 4.9%. In contrast, 60%of patients in the USA were diagnosed when they had stage I disease. The reason for late presentation may be due to low socioeconomic status and lack of awareness regarding the disease.
In India, larger proportions of patients have high-grade tumors and positive axillary lymph nodes. In the present study, 39.3% tumors were of grade III, and 81.9% of the patients had positive axillary lymph nodes at diagnosis. In developed countries, the majority of the patients have negative lymph nodes. Other Indian studies also have documented a higher proportion of lymph node–positive disease compared with the West [5]. The difference could be attributed to the well-established screening programs in developed countries.
Seroma formation is the most common complication after breast cancer surgery. If left untreated, it can lead to delayed wound healing, pain, skin necrosis, and infection and thereby a delay in adjuvant radiotherapy and chemotherapy.
Seroma is thought to be formed by acute inflammatory exudates in response to injury and acute phase of wound healing. The dissection in mastectomy and axillary lymphadenectomy injures several small blood vessels and lymphatics with subsequent oozing of blood and lymph from the raw surface area [6].
The key to reducing seroma formation seems to lie in the obliteration of dead space partly. However, the techniques used to achieve this goal are subject to much controversy. This study demonstrates that the reduction of dead space after modified radical mastectomy using flap fixation reduces seroma formation.
Petrek et al. showed that the most significant influencing factors in the development of seroma were the number and the extent of axillary lymph node involvement [7]. However, Gonzalez et al. and Hashemi et al. reported that the only statistically significant factor influencing the development of seroma was the type of surgery [4, 8]. They showed that there was a higher incidence of seroma formation in modified radical mastectomy than in wide local excision and axillary dissection.
The percentage of clinically significant seroma formation was 25/61 (40.9%). Flap fixation is associated with a lower incidence of seroma after mastectomy as compared with the control group (26.7% vs 54.8%). The percentage observed was within the incidence range that reported in the literature [9–11].
Historically, Halsted suggested obliteration of the dead space particularly in the axilla to facilitate wound healing. Several investigators have also found that the flap fixation technique is useful in decreasing seroma formation. Recently, Chilson et al. noted that there was a reduction in the incidence of seroma formation when flap tacking was done [12].
O’ Dweyer et al. reported that closing the dead space by suturing skin flaps to the underlying muscle leads to the reduction in seroma formation after mastectomy [13]. Coveney et al. showed significantly less drainage in the flap fixation group as compared with the conventional skin flap closure [9]. Purushotham et al. reported that breast surgery without drainage did not increase seroma formation if flaps were fixed with sutures [10]. The axillary flap fixation with sutures was found useful to avoid axillary drainage in patients undergoing breast conservation surgery and axillary lymph node dissection [14].
Many methods have the potential to reduce the incidence of seroma. Inconsistent results have been reported for shoulder immobilization, pressure dressing, and high- versus low-pressure drainage [7, 15–19]. Other interventions like fibrin sealant, bovine thrombin, and steroids were found ineffective [20]. Carcoforo et al. reported that octreotide which is a long-acting somatostatin analogue was found useful in reducing the incidence of seroma [21].
Although many factors have been correlated with seroma formation, there was no risk factor supported by evidence, and it is a subject of controversy. The present evidence relates the increase in the incidence of seroma to electrocautery because of increased thermal trauma [22]. There were no significant differences noted between the two groups for age, BMI, menopausal status, grade of the tumor, nodal status, tumor size, side affected, stage of the tumor, and the presence of diabetes and neoadjuvant chemotherapy.
In the present study, the overall complication rate is 16.4% (10/61) with no mortality. This rate is lower compared with that reported in the literature. Reported studies showed up to 30% of surgical morbidity among patients undergone breast and axilla surgery [9–11]. Here, complications rates (hematoma, surgical site infection, and partial flap necrosis) were less in the flap fixation group as compared with the control. There was no significant difference in patients developing SSI and flap necrosis between the two groups.
Conclusion
Flap fixation is a surgical technique that obliterates the dead space in patients undergoing modified radical mastectomy. It appears to reduce the total volume of fluid drained, the development of seroma and the need for seroma aspirations.
However, this technique should be tried on a much broader scale to prove its validity in decreasing the incidence of seroma formation and its subsequent complication so that it can be introduced as a step in the mastectomy procedure.
Acknowledgments
We acknowledge the help and support of Dr. Dinesh H N, Professor and Head of the Dept. of General Surgery, and Dr. Madhu B S, Professor of General Surgery, for completing this study.
Abbreviations
- MRM
modified radical mastectomy
- SSI
surgical site infection
Compliance with Ethical Standards
Competing Interests
The authors declare that they have no conflict of interest.
Footnotes
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Contributor Information
Ajith Vettuparambil, Email: ajitvl@gmail.com.
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