Abstract
The present randomized controlled study aimed to investigate the effects of TopClosure® tension-relief system (TRS) on patients with breast cancer undergoing mastectomy. A total of 402 female patients with breast cancer who came to the Renmin Hospital of Wuhan University between March 2014 and June 2018 were involved in the present study. All patients receiving mastectomy were randomly divided into the TRS group (n=201) and the control group (n=201). Serum levels of high-sensitivity C-reactive protein, TNF-α, IL-6 and procalcitonin were measured using ELISA. Vancouver Scar Scale was recorded at 2 weeks and 1-3 and 6 months following the operation. The 36-Item Health Survey Scales were performed for all patients at 1 month after surgery. The TRS reduced the incidence of flap necrosis, infection and the duration of hospital stay. In addition, the TRS was found to attenuate inflammation and improve scar outcomes as well as the quality of life. It was concluded that the TRS could significantly improve the clinical outcomes.
Keywords: tension-relief system, breast cancer, mastectomy, clinical outcomes, inflammation
Introduction
Breast cancer is one of the commonest female malignancy worldwide, accounting for 25% of female cancer cases (1). The morbidity of breast cancer is up to 11.6%, with mortality of 6.6% across the world (2). Patients with high tumor stage have rather poor prognosis. In recent years, more and more patients with breast cancer in early stage have been diagnosed by breast cancer screening (3). Consequently, surgery can be one of the options for them.
Mastectomy is the commonest surgical procedure for patients with breast cancer in China (4). A variety of complications, such as skin flap necrosis, wound dehiscence, inferior quality scarring, and infection, may be triggered by tissue resection with high tension wound closure, excessive wound gap and defects in surgery. In some cases, a skin graft or flap mobilization can be used if the surgical wound cannot be primarily closed (5). TopClosure® tension-relief system (TRS) is a simple and practical system for skin stretching and wound closure-secure. For patient undergoing valgus cystectomy, TRS is a useful method to repair the large abdominal defect in abdominal reconstruction with shorter operative duration and hospital stay. TRS can clearly improve wound aesthetics (6). TRS shows high efficacy for the closure of moderate and large scalp defects and serves as a topical tension-relief platform for tension sutures (6). TRS can reduce local complications, shorten hospital stay and reduce donor site morbidity (7). However, few studies report the effect of TRS application on patients with breast cancer undergoing mastectomy.
The present study was a randomized controlled study to investigate the effect of TRS on clinical outcomes and prognosis for patients with breast cancer undergoing mastectomy. The results showed that application of TRS could significantly improve the clinical outcomes, attenuated inflammation and improve wound aesthetics.
Materials and methods
Patients
The present study enrolled 402 female patients diagnosed with breast cancer, who underwent mastectomy without reconstruction between March 2014 and June 2018. The inclusion criteria were: i) All the patients were diagnosed as breast cancer by histopathological examination; ii) breast cancer was diagnosed for the first time and identified as primary breast cancer; iii) none of the patients received any chemotherapy or radio-therapy before the study and iv) patients were without serious cardiovascular diseases, renal, or liver dysfunctions. The following patients were excluded: i) Patients with other primary malignant tumors or metastatic breast cancer and ii) patients who had received prior breast surgery. Cancer stage was evaluated according to the 8th edition of American Joint Committee on Cancer (AJCC) Cancer Staging Manual (8). The present study was approved by the Ethics Committee of Renmin Hospital of Wuhan University (approval number WHRMH-214-019A). Written informed consent was obtained from all participants.
All patients received mastectomy and were randomly divided into two groups, TRS group and control group (n=201 for each group) using a computer-generated list by Rv. Uniform formula using SPSS software (SPSS Inc.). Patients in TRS group used a Tension-relief System (TopClosure®, IVT Medical Ltd.) for wound closure and patients in control group received primary suture closure after mastectomy.
TopClosure® TRS
After mastectomy, attachment plates were placed ~3-5 cm away from wound edges, rendered firmly adherent to the skin on both sides and secured to the skin-by-skin staples (Weck; Teleflex Incorporated.). Wound edges were approximated by stress relaxation through tension sutures (Ethicon, Inc.) as previously described elsewhere (9). A strap was then tightened gradually to finalize immediate primary closure of the wound. Drains were placed in the axilla or under the flap. Definite need for closure with skin graft or flap was considered technically as a failure.
All patients were managed according to a standard protocol. Drains were removed once daily with drainage <50 ml. Patients were discharged if drains were removed without signs of wound or systemic complication requiring in-hospital treatment.
Measurement of inflammatory factors and white blood cell count
Serum levels of high-sensitivity C-reactive protein (hs-CRP), TNF-α, IL-6 and procalcitonin (PTC) were detected using ELISA. Commercial ELISA kits used were as follows: hs-CRP (cat. no. MBS3800421; range ~1-16 mg/l; MyBioSource, Inc.), TNF-α (cat. no. ab181421; range ~15.63-1,000 pg/ml), IL-6 (cat. no. ab178013; range ~7.8-500 pg/ml) and PTC (cat. no. ab221828; range ~6.25-400 pg/ml; all from Abcam). White blood cell count was detected using a Coulter automatic blood cell analyzer DxH800 (Beckman Coulter, Inc.).
Vancouver scar scale (VSS) and 36-item health survey scales
The present study used VSS to measure the scar conditions of the patients. The 36-Item Health Survey Scales (10) were used for measurement of quality of life.
The VSS provides a numerical score of the worst portion of a scar to describe scar quality, rating characteristics of pigmentation, vascularity, pliability and height (11). Higher score of VSS generally indicates worse condition for scaring. The 36-Item Health Survey Scales is usually used for evaluating quality of life (12). The 36-Item Health Survey Scales contains eight parameters, including physical function, role-physical, pain, general health, emotional well-being, role-emotional, social function and energy/fatigue. Higher score in each parameter suggests improved quality of life.
Data collection
Demographic and clinical data included age, body mass index, tumor stage, complications, side of operation, pathological type, tension of skin flap closure, hospital length of stay, flap necrosis, total volume of aspirate and the incidence of infection and subcutaneous liquid accumulation. VSS score was recorded at 2 weeks and 1-3 and 6 months following surgery, respectively. The 36-Item Health Survey Scales were performed for all patients at 1 month following surgery. Once mastectomy was completed, the margin gap created was assessed intraoperatively (Fig. 1A-D). Patients with margin gaps <4 cm were considered as having a low-tension closure wound closure whereas patients with margin gaps >4 cm were considered as having a high-tension wound closure. All the patients were followed up for 6 months.
Figure 1.
A 46-year-old patient received modified radical mastectomy due to ductal breast cancer. (A) A high-tension flap with 12 cm wide wound gap. (B) Direct primary closure was achieved by cycling of stress-relaxation by tension sutures over the TopClosure® tension-relief system. (C) At 12 days after surgery. (D) At six months after surgery.
Statistical analysis
Statistical analysis was performed using SPSS 18.0 (SPSS, Inc.). Normally distributed data were expressed by mean ± standard deviation, while non-normally distributed data were expressed by median (range). Comparison between two groups was made using the Student's t-test or Mann-Whitney U test. Comparison among three or more groups was conducted using one-way analysis of variance followed by Tukey post hoc test. The rates were compared by χ2 test. P<0.05 was considered to indicate a statistically significant difference.
Results
The baseline characteristics of the two groups
The present study enrolled 402 patients with breast cancer undergoing mastectomy. The mean age was 43.7±6.89 years. The baseline characteristics of all patients are listed in Table I. Patients in the TRS group had higher ratio of skin flap closure with low-tension than the control group. There were no significant differences for the other basic characteristics between the two groups. Fig. 1A-D showed the process of wound healing for a 46-year-old patient undergoing modified radical mastectomy with TopClosure® TRS application.
Table I.
Baseline characteristics of all patients.
| Characteristic | TRS group n=201 | Control group n=201 | P-value |
|---|---|---|---|
| Age, year | 45.22±8.67 | 44.65±7.69 | 0.488 |
| BMI, kg/m2 | 24.05±2.49 | 23.88±1.94 | 0.422 |
| Hypertension, n (%) | 28 (13.93) | 26 (12.94) | 0.770 |
| Diabetes, n (%) | 18 (8.96) | 20 (9.95) | 0.865 |
| Side of operation | |||
| Left, n (%) | 113 (56.22) | 96 (47.76) | 0.110 |
| Right, n (%) | 88 (43.78) | 105 (52.24) | |
| TNM stage, n (%) | |||
| I | 35 (17.41) | 40 (19.90) | 0.792 |
| II | 126 (62.69) | 124 (61.69) | |
| III | 40 (19.90) | 37 (18.41) | |
| Pathological type, n (%) | |||
| Invasive ductal carcinoma | 151 (75.12) | 159 (79.10) | 0.598 |
| Invasive lobular carcinoma | 34 (16.92) | 30 (14.93) | |
| Mucinous adenocarcinoma Tumor diameter, n (%) | 16 (7.96) | 12 (5.97) | |
| >2 cm | 155 (77.11) | 141 (70.15) | |
| ≤2 cm | 46 (22.89) | 60 (29.85) | |
| Skin flap closure | |||
| LTW, n (%) | 109 (54.23) | 121 (60.20) | 0.267 |
| HTW, n (%) | 92 (45.77) | 80 (39.80) |
LTW, low-tension closure wound; HTW, high-tension closure wound.
TopClosure® TRS attenuates inflammatory response in postoperative patients with breast cancer
Serum levels of hs-CRP, TNF-α, IL-6 and PTC and white blood cells (WBC) were detected 2 weeks following surgery. The results showed that the levels of WBC, hs-CRP, TNF-α and IL-6 in TRS group were evidently lower compared with the control group (Table II). No significant difference was observed for serum PTC contents between the two groups. This suggested that TRS application clearly attenuated inflammation in patients with breast cancer following surgery.
Table II.
Comparison of inflammatory factors between the two groups.
| Inflammatory factor | TRS group, n=201 | Control group, n=201 | P-value |
|---|---|---|---|
| WBC, x109/l | 8.96±2.35 | 10.32±2.51 | <0.001 |
| hs-CRP, mg/l | 1.05±0.16 | 1.13±0.25 | <0.001 |
| TNF-α, pg/ml | 103.97±20.79 | 128.75±34.74 | <0.001 |
| IL-6, pg/ml | 294.05±61.54 | 354.02±91.43 | <0.001 |
| PTC, ng/ml | 163.73±80.79 | 168.37±65.24 | 0.526 |
WBC, white blood cells; hs-CRP, high-sensitivity C-reactive protein; PTC, procalcitonin.
TopClosure® TRS improves the clinical outcomes of postoperative patients with breast cancer
The clinical outcomes were analyzed for patients with breast cancer following surgery. As shown in Table III, compared with the controls, TRS application significantly reduced the incidence of flap necrosis (0/201; 0%) and infection (8/201; 3.98%) as well as the duration of hospital stay (10.62±1.52 days). The findings indicated TRS application markedly improved clinical outcomes for patients with breast cancer following surgery.
Table III.
Comparison of clinic outcomes between two groups.
| TRS group n=201 | Control group n=201 | P-value | |
|---|---|---|---|
| Flap necrosis, n (%) | 0 (0) | 28 (13.93) | <0.001 |
| Seroma formation, n (%) | 38 (18.91) | 43 (21.39) | 0.619 |
| Total volume of aspirate, ml | 378±72.87 | 384.69±77.87 | 0.485 |
| Infection, n (%) | 8 (3.98) | 30 (14.92) | <0.001 |
| Hospital length of stay, days | 11.17±2.05 | 13.22±3.18 | <0.001 |
TRS, tension-relief system.
TopClosure® TRS improves quality of life and decreases severity of scarring
In order to evaluate the quality of life, a survey of 36-Item Health Survey Scales was conducted for all patients at 1 month following surgery. The result revealed that patients receiving TRS treatment had higher scores of physical function, emotional well-being and general health (Table IV). The VSS scores were recorded at 2 weeks and 1-3 and 6 months following surgery. As shown in Fig. 2, VSS score of patients in TRS group was significantly lower than the controls, suggesting improved wound healing. These results suggested that TRS application notably improved qulaity life and the scar outcomes.
Table IV.
Comparison for 36-Item Health Survey Scales between two groups.
| Parameters | TRS group n=201 | Control group n=201 | P-value |
|---|---|---|---|
| Physical function | 55.12±18.07 | 49.58±13.47 | 0.001 |
| Role-physical | 40.55±26.88 | 38.06±27.73 | 0.362 |
| Pain | 44.84±15.93 | 47.30±18.24 | 0.149 |
| General health | 37.75±12.60 | 34.05±14.93 | 0.008 |
| Emotional well-being | 50.31±19.11 | 44.22±15.10 | <0.001 |
| Role-emotional | 33.67±27.69 | 34.49±26.95 | 0.761 |
| Social function | 39.30±25.04 | 35.88±24.18 | 0.164 |
| Energy/fatigue | 68.81±18.52 | 65.60±18.59 | 0.084 |
TRS, tension-relief system.
Figure 2.
Dynamic change of VSS score in the two groups. VSS score was detected at 14, 30, 60, 90 and 180 days following surgery. ***P<0.001. VSS, Vancouver Scar Scale; TRS, tension-relief system.
Discussion
Skin flap necrosis is a common complication of mastectomy affecting ~3-32% of patients (13-15). In order to avoid skin flap necrosis, accelerate wound healing and to shorten hospital stay, the application of skin-stretching devices has been described in various studies (16-18). In the present study, TRS skin stretching together with secure wound closure device were used to treat the surgical wounds of mastectomy. It was observed that TRS notably improved the clinical outcomes and quality of life as well as decreasing the severity of scarring and inflamation. Consequently, TRS might be a potential skin-stretching device for patients with breast cancer during mastectomy.
In the present study, no skin flap necrosis was observed in TRS group. This might be attributed to the novel characteristics of the TRS. Reportedly, two malleable attachment plates (APs) in TRS can be flexibly fixed to wound margins. Primary wound closure can be achieved by stress relaxation through tension sutures without injuring the underlying skin. The plates serve as a tension-relief platform, shielding the skin from direct damage of the tension sutures, reducing modified radical mastectomy flap tension, especially in cases of high-tension flaps. Moreover, the flap is tightly fixed to the chest after fixation and stretch of the APs. Thus, eliminating dead space and promoting angiogenesis (19-21). Hence, incidence of flap necrosis is reduced. Furthermore, the device can also be used for immediate or delayed primary closure of large wounds by stress relaxation during surgery (7,22). By contrast, conventional (relaxation-suturing) tension suturing induces high and non-uniform tension on the flap margins, resulting in local ischemia, necrosis, scarring and wound dehiscence. Due to the expected high-tension closure and high rate of recurrence, primary closure is not suitable for large skin defects. Therefore, TRS has become a promising option for skin stretching and wound closure-secure for trauma and oncologic surgery.
Emerging evidence illustrates that TRS serves as substitute for skin grafts, tissue expanders and flap (23). The TRS significantly restrained blood loss and reduced donor site morbidity, as well as improving wound aesthetics and minimizing the risk for future reconstructive procedure in a 3-day-old female infant undergoing surgical resection of the giant scalp hemangioma (24). The same results can be found in some other cases. For instance, a case study on a 36-year-old man receiving surgical resection of the keloid showed that primary closure with TRS contributed to simplified surgical procedures and reduced the operative time (25). Meanwhile, TRS contributes to cosmetic improvements of scarring and decreases the probability of future reconstructive procedures of anterior chest wall (25). Ashkenazi et al (26) found that a large skin defect treated with TRS could avoid extending the scope of surgery with skin grafting or flaps, as well as reducing possibility of donor site morbidity. In addition, TRS exhibits the potential for immediate primary closure of high-tension mastectomy wounds (26). For the closure of extensive wounds, TRS reduces the incidence of major complications, such as wound dehiscence or infections; moreover, all healed wounds were stable in one-year follow-up (27).
However, the application of TRS is only illustrated in few case reports. The present study conducted a randomized controlled study to investigate the effect of TRS on breast surgery for patients with breast cancer. The results showed that TRS reduced the incidence of flap necrosis and infection, shortened hospital stay, improved wound aesthetics and the quality of life. These findings were consistent with the above previous studies (24-27). Surgery may trigger acute inflammatory response, which shows close association with the clinical outcomes. Lee et al (28) reveals that postoperative inflammation was an important risk factor for the mortality of patients with breast cancer. The present study noted that TRS application decreased inflammation following surgery. Thus, it was hypothesized that it might affect the prognosis in a long term, which needs further investigation in the future.
The present study also had some limitations. One concern about the findings is that the sample size was too small. In addition, the data were collected from one single center instead of multicenter.
In conclusion, skin stretching and secure wound closure was effectively achieved by the TRS with primary closure. TRS significantly improved clinical outcomes and the quality of life for patients with breast cancer, as well as suppressing postoperative inflammation and infections. TRS might be a novel potential skin-stretching device for mastectomy.
Acknowledgements
Not applicable.
Funding Statement
Funding: No funding was received.
Availability of data and material
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Authors' contributions
MY and HF conducted most of the experiments and HF wrote the manuscript; HJ and ZZ conducted the experiments and YZ analyzed the data, MY designed the study and revised the manuscript. MY and HF confirm the authenticity of all the raw data. All authors read and approved the final manuscript.
Ethics approval and consent to participate
The present study was approved by the Ethics Committee of Renmin Hospital of Wuhan University (approval number WHRMH-214-019A).
Patient consent for publication
Not applicable.
Competing interests
The authors declare that they have no competing interests.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.