|Year : 2021 | Volume
| Issue : 12 | Page : 1779-1784
Randomised controlled study of seroma rates after mastectomy with and without quilting the skin flap to pectoralis muscle
S Yilmaz1, MR Aykota1, TY Baran1, N Sabir2, E Erdem1
1 Department of General Surgery, Faculty of Medicine, Pamukkale University, Denizli, Turkey
2 Department of Radiology, Faculty of Medicine, Pamukkale University, Denizli, Turkey
|Date of Submission||12-Jan-2021|
|Date of Acceptance||17-Jun-2021|
|Date of Web Publication||09-Dec-2021|
Dr. M R Aykota
Department of Surgery, Pamukkale University School of Medicine, Denizli
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Aims: The aim of this study was to determine whether seroma formation was affected by reduction of the potential dead space with the flap fixation method and obliteration of the axillary region in patients with breast cancer who underwent either mastectomy and axillary lymph node dissection or sentinel lymph node biopsy. A total of 105 patients with breast cancer were divided into two groups according to wound closure patterns. Patients and Methods: The operating time, postoperative pain and complications, time to drain removal, seroma formation, amount of fluid aspirated and number of aspirations were recorded prospectively. Results: No significant difference was found between groups in the rates of seroma development (P = 0.7), complication rates (P = 0.6), time to drain removal (P = 0.5), length of hospital stay (P = 0.3) or numbers of aspiration (P = 0.7). The operating time for fixation was determined to be longer than that of the classic procedure (P = 0.02). Conclusions: Reducing potential dead space with flap fixation and obliteration of the axillary region may be useful in decreasing the development of seroma in patients who have undergone mastectomy because of breast cancer. However, surgical technique must be careful, and appropriate patient follow-up must be conducted.
Keywords: Mastectomy, postmastectomy seroma, ultrasonography
|How to cite this article:|
Yilmaz S, Aykota M R, Baran T Y, Sabir N, Erdem E. Randomised controlled study of seroma rates after mastectomy with and without quilting the skin flap to pectoralis muscle. Niger J Clin Pract 2021;24:1779-84
|How to cite this URL:|
Yilmaz S, Aykota M R, Baran T Y, Sabir N, Erdem E. Randomised controlled study of seroma rates after mastectomy with and without quilting the skin flap to pectoralis muscle. Niger J Clin Pract [serial online] 2021 [cited 2022 Jan 23];24:1779-84. Available from: https://www.njcponline.com/text.asp?2021/24/12/1779/332074
| Introduction|| |
Despite the recent development of many methods and techniques in the surgical treatment of breast cancer, which is the most common cancer in women, mastectomy is still the general treatment method. The most common complication after mastectomy is the development of seroma below skin flaps. Seroma is the accumulation of serous fluid in the axilla or underneath skin flaps after mastectomy and can be identified clinically or sonographically. Seroma is subdivided into three types: Grade 1 is asymptomatic (can be identified with only by ultrasonography), grade 2 is symptomatic but can be treated with medical treatment or simple aspiration and grade 3 is symptomatic and requires surgical or radiological intervention. The incidence of seroma has been reported to vary from 3% to 90%.
Seroma can increase the chances of postoperative complications such as delayed wound healing, surgical site infection, necrosis in skin flaps, persistent pain and opening of the wound site, and the start of adjuvant treatment may be delayed because the healing process is thus prolonged. The pathophysiologic causes of seroma formation are well known, the primary reasons include inflammatory reactions related to the surgery, injury to lymphatic or other vascular structures and the development of a dead space after removal of breast tissue or axillary tissue., According to the literature, many techniques have been used to limit the incidence and severity of seroma, primarily external compression clothing, drains, types of cauterization, shoulder immobilization, tetracycline, sclerotherapy, fibrin adhesives, octreotide injection and suturing methods to reduce the dead space.,,,,,,
According to recent publications about breast reconstruction, significant improvement has been achieved with the use of sutures in deep inferior epigastric flaps and the latissimus dorsi flap donor site and in flap fixation., The aim of this study was to determine whether seroma formation was affected by reduction in the potential dead space with the flap fixation method and obliteration of the axillary region in patients with breast cancer who underwent mastectomy alone or with axillary lymph node dissection (ALND) or sentinel lymph node biopsy (SLNB).
| Materials and Methods|| |
This prospective study was conducted on a total of 105 patients in the General Surgery Department of Pamukkale University Medical Faculty, Denizli, Turkey, between 1 September 2017 and 31 January 2019. Approval for the study was granted by the Non-Interventional Clinical Research Ethics Committee of Pamukkale University Medical Faculty (decision no. E.81507, dated 12 June 2017).
Inclusion criteria of the study were as follows:
- Breast cancer in a woman who planned to undergo mastectomy either alone or with SLND or ALND.
- Age of 18 years or older.
Exclusion criteria were as follows:
- Mastectomy with breast reconstruction planned for the same session.
- A history of known degenerative neuromuscular disease (thoracic muscular disease).
Informed consent was obtained from all the patients in the study.
The study was designed as a double-blind, prospective, randomized study. Before the study, a list of numbers was given to an assistant for randomization, and at the closure stage at the end of the operation, the surgeon was informed which technique was to be applied. All the operations were performed by the same surgical team. Patients were evaluated clinically and ultrasonographically for wound site seroma 3 and 8 weeks after surgery [[Figure 1]: Flow Chart]. Throughout the follow-up period, the patient was not informed which closure technique had been used.
A total mastectomy was performed all the patients with a modified Steward incision, including the nipple-areola complex and, if present, previous biopsy scar. Electrocauterization was used as part of standard surgical dissection, and the lower and upper skin flaps were prepared. The same mastectomy incision was used for axillary grading. To the patients who underwent total mastectomy alone or with SLNB, a closed drain was placed in the anterior pectoral region. In patients who underwent total mastectomy with ALND, a second closed drain was placed in the axillary region. During SLNB or ALND, vascular and lymphatic vessels were dissected carefully by tying with 3/0 Vicryl, as is routine in our unit. In patients undergoing flap fixation, the skin flaps were sewed to the underlying pectoralis major muscle at approximately 2- to 3-cm intervals with 3/0 Vicryl sutures. In patients undergoing ALND, fixation was made to the medial inferior wall of the axilla and to the lateral wall toward the anterior surface of the serratus muscle with separate 3/0 Vicryl sutures, so that no dead space would be left [Figure 2]. Subcutaneous tissues were closed with 3/0 Vicryl sutures at intervals, and the skin was closed with staples. In patients undergoing classic wound closure, all the steps were the same except for the flap fixation.
|Figure 2: Fixation of the upper flap (a), the axilla (b), and subcutaneous tissue (c)|
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The compression dressing was applied for all the patients, and these dressings were removed after 48 hours. A daily record was kept of the amount and nature of the drainage. When the amount of daily drainage fell below 20 mL, the drains were removed.
Shoulder movement exercises were started on the first day postoperatively. The operating time, degree of postoperative pain and complications (bleeding, surgical site infection, flap necrosis) were recorded. After drain removal, the patients were evaluated clinically and with ultrasonography for seroma development 2 days a week for the first 3 weeks and again after 8 weeks for late seroma formation. When seroma that necessitated aspiration was present, the amount of fluid drained and the number of aspirations were recorded. Post-operative pain measured with the visual analogue scale pain scoring system from 0 (no pain) to 10 (unbearable pain) recorded.
The primary outcomes of the study differences between the groups with regard to seroma and the differences between the rates of the other secondary results were evaluated with Chi-square and Fisher's exact tests, and the differences between the mean values were evaluated with the t test and the Mann Whitney U test. When necessary, regression analysis was applied. A P value of less than 0.05 was considered statistically significant.
| Results|| |
The study included a total of 105 patients. Classic wound closure after mastectomy was performed in 53 (50.5%) and wound closure with flap fixation in 52 (49.5%). The mean age of the patients was 53.1 ± 12.4 years (range, 25–80 years), and mean body mass index was 26.7 ± 4.7 (range, 14–41) [Table 1] (T. Hypertension was present in 11 patients (10.5%), diabetes mellitus in 3 (2.9%), both hypertension and diabetes mellitus in 17 (16.2%) and ischemic heart disease in 3 (2.9%). Eighteen patients (17.1%) had a history of anticoagulant drug use. ALND was performed in 28 (26.7%).
The two groups of patients did not differ significantly with regard to age, body mass index, tumor diameter and grade [Table 1]. Of the patients who underwent fixation, 45 (42.9) had invasive ductal carcinoma, 3 had invasive lobular carcinoma, none had ductal carcinoma in situ and 4 had other pathological types of cancer. Of the patients who underwent classic surgery, 34 (43%) had invasive ductal carcinoma, 5 had invasive lobular carcinoma, 5 had ductal carcinoma and 9 had other pathological types of cancer. The classic wound closure method was used in more cases of invasive lobular carcinoma, in situ carcinoma and other pathological types, and the fixation method was used more in cases of invasive ductal carcinoma (P = 0.03).
In the evaluation of postoperative complications, bleeding was determined in 1 patient (1%), infection in 3 (2.9%), flap necrosis in 2 (1.9%) and ecchymosis in the flap in 1 (1%). The complication rates in the two groups did not differ significantly (P = 0.6). In 62 patients (59.6%), the tumors were stage 2; in 49 (46.7%), nodal stage 1; in 73 (69.5%), grade 2 and in 79 (75.2%), invasive ductal carcinoma. The location of the cancer was in the right breast in 53 patients (50.5%), in the left breast in 48 (45.7%) and bilateral in 4 (3.8%) patients. Neoadjuvant chemotherapy was administered to 21 (20%) patients.
The mean postoperative pain scores were 3.5 ± 1.7 in patients undergoing classic surgery and 2.9 ± 1.8 in those undergoing fixations; the difference was not statistically significant (P = 0.1). The mean operating time for fixation was 100.1 ± 17.4 min, which was longer than that for classic surgery (92.3 ± 17.1 min; P = 0.02). The mean length of hospital stay after classic surgery was 3.36 ± 2.01 days, and that after fixation was 3 ± 1.6 days in the fixation group; this difference was not statistically significant (P = 0.3).
Seroma was determined to be present after mastectomy in 58 (55.2%) patients; the proportions of patients with seroma in the two groups were not significantly different (P = 0.7). The rates of seroma determined with postoperative ultrasonography did not differ significantly between the two groups (P = 0.8 at 3 weeks and P = 0.8 at 2 months). There was no statistically significant difference between the groups with regard to the number of postoperative seroma aspirations (P = 0.3). The rate of seroma development in patients who underwent ALND did not differ from that in patients who did not undergo ALND (P = 0.2; [Table 2]).
| Discussion|| |
Extensive dissection during mastectomy and axillary lymph adenectomy leads to various vascular and lymphatic injuries, and the accumulation of lymphatic fluid increases the risk of seroma formation. To prevent seroma formation, the most important factor is the reduction of potential dead space.
The closed drainage system, which has traditionally been used for many years in the prevention of the postoperative development of seroma and associated complications, is not always sufficient. Other methods such as compression clothing and pressure dressings have been reported in literature to be ineffective in preventing the formation of seroma.,
The flap fixation method in which skin flaps are sutured to the underlying muscle tissue and fascia, thereby obliterating the axillary space, has been reported in several studies to be an inexpensive and simple method that significantly decreases seroma formation.,,, This study was a comparison of the rates of seroma development after mastectomy performed with two different surgical methods, and these rates were not significantly different [Table 2]. Moreover, no statistically significant difference was determined between the two groups with regard to seroma-related postoperative complications such as wound site infection and flap necrosis. Van Bastelaar et al. found no difference between two similar groups in rate of surgical site infections. In a prospective study by Mazouni et al. the incidence of surgical site infection was not affected by fixation. However, ten Wolde et al. reported that surgical site infection was observed less in the patients who underwent fixation (11.2%) than in those who did not (31.0%; P < 0.01). In addition, as in this study, other studies have demonstrated that the incidence of seroma was reduced with the axillary padding method.
In the current study, although the mean total drainage volume after classic surgery (193.6 mL) was higher than that after fixation (173.9 mL), the difference was not statistically significant [Table 2]. However, in examining similar studies in the literature, Khater et al. found the total drainage volume to be significantly lower after fixation. Sakkary also found total drainage volume was determined to be significantly lower after fixation.
The mean time until drain removal in this study was 3.9 days after flap fixation and 4.6 days after classic surgery, but the difference was not statistically significant [Table 2]. In studies by both Khater et al.and Sakkary however, the time to drain removal was significantly shorter after fixation. In a prospective randomized study by Faisal et al. of patients undergoing modified radical mastectomy, the time to drain removal was significantly shorter and the total drainage amount was significantly less among patients who underwent axillary exclusion than among those who underwent conventional surgery.
The number of seroma aspirations in this study did not differ significantly between the study groups [Table 2], but similar studies have demonstrated a lower number of aspirations after fixation., As expected, the operating time for fixation was determined to be significantly longer than that of for classic surgery in the current study [Table 2]. Khater et al. similarly reported a longer operating time for fixation. The postoperative pain scores in the current study did not differ significantly between the two groups [Table 2].
In a prospective, randomized study by Petrek et al. the most important factor in seroma development was found to be the extent of ALND and the number of lymph nodes removed. However, in other studies, seroma development has been reported to vary only in relation to the surgical method., According to these findings, rates of seroma were highest after modified radical mastectomy. In this study, no significant difference in seroma development was determined between patients who underwent ALND and those who did not.
Although the results of this study showed no statistically significant difference between the two groups in respect of seroma development and amounts of fluid aspirated, the suture technique was beneficial in the prevention of seroma in selected patients (e.g. those with macromastia and those with factors that hamper wound healing, such as diabetes). The absence of a significant difference between the patients can be attributed to factors such as fastidious surgical technique, the careful application of hemostasis, not performing dissection without tying areas where there were potential lymphatic channels at every stage of the axillary dissection procedure, the postoperative use of dressings at effective pressure and not removing the drains before the daily drainage amount had fallen to below 20 mL.
The limitations of this study are to place the drainage in both wound closure groups and wait for the amount of daily drainage to decrease too much (daily drainage drops below 20 mL) to remove the drains.
| Conclusions|| |
Reducing potential dead space with flap fixation and obliteration of the axillary region may be useful in decreasing the development of seroma in patients who undergo mastectomy for breast cancer, but surgical technique must be careful, and appropriate patient follow-up must be conducted.
Declaration of patient consent
Informed consent was obtained from all individual participants included in the study.
The authors would like to thank Enago for the English language review. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2]