*Contributed equally
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.
Breast cancer is one of the commonest female malignancy worldwide, accounting for 25% of female cancer cases (
Mastectomy is the commonest surgical procedure for patients with breast cancer in China (
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.
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 (
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.
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 (
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.
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.).
The present study used VSS to measure the scar conditions of the patients. The 36-Item Health Survey Scales (
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 (
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 (
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.
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
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 (
The clinical outcomes were analyzed for patients with breast cancer following surgery. As shown in
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 (
Skin flap necrosis is a common complication of mastectomy affecting ~3-32% of patients (
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 (
Emerging evidence illustrates that TRS serves as substitute for skin grafts, tissue expanders and flap (
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 (
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.
Not applicable.
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
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.
The present study was approved by the Ethics Committee of Renmin Hospital of Wuhan University (approval number WHRMH-214-019A).
Not applicable.
The authors declare that they have no competing interests.
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.
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.
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.
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.
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.
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.