Jose Manuel de León Carrillo^*1, Carmen Victoria Almeida González², Carmen Victoria Almeida González², Gonzalo de Castro Parga³,Inmaculada Alonso Vargas⁴, Pilar Rioja Torres⁵, María Jose Cantero Rodríguez², CarmenGata Cala¹, MaríaErmitasDávila Casal³, MaríaJesús Sánchez Sánchez⁴, Rafael GalisteoDomínguez², AldaCardesin Revilla⁶, Antonio PiñeroMadrona⁷

1. Hospital UniversitarioVirgen del Rocío, Sevilla, España

2. Hospital UniversitarioVirgen de Valme, Sevilla, España

3. ComplejoHospitalarioUniversitario de Vigo, Vigo, Pontevedra, España

4. Hospital Clínic, Barcelona, España

5. Hospital Universitario Reina Sofía, Córdoba, España

6. Hospital ParcTaulí, Sabadell, Barcelona, España

7. Director GrupoEstudiosSenológicos de la SESPM

^*Corresponding author: Jose Manuel de León Carrillo, Hospital UniversitarioVirgen del Rocío, Sevilla, España, Spain

Abstract

Objectives: To demonstrate that the use of controlled compression orthosis versus classic compressive dressing reduces postoperative complications in conservative breast cancer surgery.Patients and Method: The 186 patients who were randomised to use an orthosis or a compressive dressing after conservative breast cancer surgery were included. Clinical-pathological variables were recorded and their relationship with the development of postoperative complications in the two weeks following surgery was studied, and a multivariate analysis was carried out with significant variables or with a tendency towards such a relationship.Results: As variables related to the appearance of postoperative complications in the two weeks following surgery we measured: medium or large size (P=.023), the use of a compressive dressing vs. an orthosis (P =.009), the intrinsic Her2neu subtype (P =.004), the use of breast drainage (P =.010) or axillary drainage (P =.017) and the extensive lymphadenectomy (P=.010). The use of a compressive dressing, the intrinsic Her2neu subtype and the use of breast drainage, persist as independent factors after the multivariate analysis.Conclusion: The compression orthosis versus the compressive dressing is an independent protective factor for early postoperative complications in breast cancer.

Keywords: breast cancer; breast-conserving therapy; postoperative complications; occlusive bandage; compressive garment

Introduction

Conservative breast and axillary surgery is the reference standard [1-6] in the surgical treatment of breast cancer, in line with the principle of applying the minimum effective treatment at both the breast and axillary levels. The evolution and surge in oncoplastic breast surgery [7] and selective sentinel lymph node biopsy for ganglionic staging8 currently include both surgical procedures in 80% and 95% of the surgical procedures indicated to achieve the best oncological, cosmetic and quality of life results, respectively.

Traditionally, once the patient has been operated on, a compressive dressing or bandage is placed over the scar on the breast, and it usually extends to the armpit in order to avoid local complications, such as bruises, serous-lymphatic collections or breast oedema, and also to reduce postoperative pain. The use of compressive dressings is not free from local complications, such as skin lesions, limitation of thoracic mobility with restrictive respiratory trouble and functional limitation of arm mobility [8,10,11].

Wearing a suitable bra that promotes good blood and lymphatic circulation of the breasts, at baseline conditions, and that, in cases of larger breasts supports their weight better, keeping the shoulders and back relaxed, has been shown to prevent the development of certain conditions such as osteomuscular pain, costoclavicular syndrome, respiratory failure, circadian rhythm disorders, and breast pain or oedema [12-17]. There are currently “well-fitted” orthoses with controlled compression that are personalised in size and cup designed to fix, mould and collect the breast from the armpit; these details are recognised as very important for postoperative care of the breast and the armpit that have undergone conservative oncological surgery, which is a surgical technique, moreover, that is not free of complications and undesirable effects, such as breast oedema, hematomas, seromas, skin lesions, pain, infection and an impact on quality of life [18-21].

An observational survey promoted by the Senological Studies Group of the Spanish Society of Senology and Breast Disease (SESPM), carried out in 2012 in the breast units of 35 Spanish hospitals, on the use of a compressive dressing versus orthosis immediately after operation in the conservative treatment of breast cancer, shows that in 53% of breast units a dressing is used versus 45%, where a bra/orthosis is used, with there being a highvariability in the type of bras used, from sports, elastic, seamless bras and those with preformed cups to specific postoperative compression bras [22].

Given all of the above, in 2016 a randomised prospective multicentre study was carried out, [22 in which the use of an orthosis was compared with that of a classic compressive dressing, with the combined incidence of complications, comfort, ease of use, aesthetic satisfaction and quality of life [23] being analysed, and the significant reduction of complications with the use of an orthosis versus a dressing two weeks after surgery being identified.

The objective of this retrospective study is to demonstrate and quantify the efficacy of orthoses versus dressings in the reduction of postoperative complications, adjusting the compression procedure for other complication predictive factors.

Patients and Method

For this, a sample was taken consisting of the 198 patients who were included in the CIR-ORT 2013 trial, [22,23] who received conservative surgery due to breast cancer, and who were followed up from 24 hours to 30 days after surgery.

In all cases, quality of life and the incidence of complications were recorded on five occasions during this time period.

The sample included cases from 5 Spanish hospitals: Virgen del Rocío University Hospital (Seville), Virgen de Valme University Hospital (Seville), Vigo University Hospital Complex, Clínic Hospital (Barcelona) and Reina Sofía University Hospital (Cordoba), and the study was promoted by the Senological Studies Group of the Spanish Society of Senology and Breast Disease. The protocol was approved by the corresponding Clinical Research Ethics Committees in all participating centres.

We included cases of women of legal age with an indication for conservative surgery for unilateral breast cancer, who granted their consent to participate in the study. We excluded patients with primary systemic therapy, with contraindications for conservative surgical treatment, those on anticoagulant treatment or those who did not accept participation.

The patients followed the normal care protocol in clinical practice and after undergoing conservative surgery and ganglionic staging, in the operating room they received thecompression system with an orthosis or a compressive dressing depending on their randomisation, carried out through the ETCETERA 2.67 software for Windows® at the time when the surgery was authorised. As an orthosis, the bra with reference 1194 by Anita Care® was used, characterised by seamless double layer preformed cups, made from cotton fabric (60%), with adjustable wide straps and side waistbands that exert regulated compression. This orthosis has a front zipper with a hook and eye fastening, which facilitates its wearing and decreases the healing time, as well as with a wide elastic band under the breast, which has cotton on the skin side, allowing controlled compression.

The classic dressing was prepared with gauzes or compresses and was applied on the injury, following protection of the skin with Nobecutan®, and was put in place with adhesive strips or surgical tape and covered the breast and the armpit, with peripheral support on the thoracic wall and the supraclavicular space. The compressive dressing was held in place for a maximum period of 48 hours and afterwards, it was replaced by a simple dressing in addition to a normal bra, which was maintained, as in the orthosis group, for 30 days. Subsequently, check-ups were carried out after 24 hours, upon discharge, and on follow-up days 7, 15 and 30.

The variables recorded were those considered to be potentially influential on the appearance of complications: age, BMI, bra size, tumour size, grade and phenotype, procedure on the breast and armpit, number of lymph nodes removed and breast and/or axillary drainage.

Local complications were considered (hematoma, breast oedema, seroma, skin complications) [24], assessment of pain through the visual analogue scale in the different check-ups, mobility of the ipsilateral upper limb, particularly the functional limitation of the shoulder or of thoracic mobility, through a physical examination and subjective assessment of the patient with the Constant-Murley scale [25]; as an efficacy measurement, we assessed the ease of use, the degree of comfort and aesthetic satisfaction through the Likert-type Usability Scale (rating from 0-5: completely dissatisfied, dissatisfied, undecided, satisfied and completely satisfied), and the quality of life was measured with the health questionnaire SF-12 [26].

The complications observed in the first two weeks after surgery were recorded with the aim of carrying out a comparative study between the groups with an orthosis and those with a compressive dressing, as well as a multivariate analysis for the complications twoweeks after surgery, with the aim of identifying and confirming treatment with compressive dressings as a predictive factor for these complications, as well as quantifying their impact.

Sample size

Considering expected complication percentages of between 20% and 40% with an α error of 5%, a bilateral test power of 80% and an estimated loss of study participants of 5%, it was necessary to analyse at least 86 patients per group, 172 in total. The calculation was performed with the nQuery Advisor 7.0 software for Windows.

Statistical analysis

Initially, the comparison of the potentially confusing variables of the relationship between the compression procedure and the general complications two weeks after surgery was carried out. Subsequently, the prediction of complications was studied univariately from their predictive potential variables. For this, Student’s t test was applied for independent samples and the nonparametric Mann-Whitney U test was applied in the case of quantitative variables. To analyse the associations between the qualitative variables and complications, contingency tables were created and the Chi-square test or the non-asymptotic methods of the Monte Carlo test and the Exacta test were applied. Lastly, a multivariate binary logistic regression model was generated for the complications event, with all the variables related to it below 25%, to try to identify the compression treatment as an independent predictor of the presence of complications.

Results

A total of 99 patients were studied in the group with orthoses and 87 with compressive dressings, whose general characteristics can be seen in Table 1. It can be seen that both groups are comparable for all the characteristics considered; however, the lymphadenectomy, the total number of lymph nodes removed, a tumour size of less than 2 cm and the result of selective sentinel node biopsy (SLNB) differed slightly by treatment, so they were considered subsequently in the final analysis for the adjustment of the compression treatment factor as a potential predictor of postoperative complications.

After the multivariate analysis, the possible variables associated with general complications two weeks after breast surgery were the size (P=.023) the phenotype of the tumour (P =.004); breast and axillary drainages (P =.010 and .017, respectively); the total number of lymph nodes removed (P =.010); and the breast compressor procedure, a factor in the study that showed a reduction of more than half in the number of complications when the orthosis was used than when the compressive dressing was used (P =0.009). We also observed the tendency for a relationship with a greater risk of complications, although without achieving statistical significance, in the type of surgery on the breast, the performing of a lymphadenectomy, the size of the tumour <2cm and the existence of lymphovascular invasion (Table 2).

Table 1. General characteristics of the study groups.

Table 2. Complication prediction factors two weeks after surgery

* Median (P25; P75), asymmetrical distribution

After the multivariate analysis of the variables that could affect this association or were univariately significant for complications, independent predictive factors were identified for the presence of postoperative complications at two weeks: the compression procedure, resulting in the orthosis protecting by a factor of 3 versus the dressing; the tumour phenotype, such that a Luminal B or Her-2 tumour would be linked two or five times more to complications, respectively, than a Luminal A; and to the use of drainage in the breast, multiplying by four the risk of the appearance of complications (Tables 3 and 4).

Table 3. Variables initially considered in the multivariate model

Table 4. Variables in the final multivariate model

Discussion

The brassiere or bra is an item of feminine lingerie with a predominantly aesthetic function. The invention of the modern bra is attributed to Pierre Poiret who, in 1907, joined two handkerchiefs with a silk ribbon and created one of the underwear items most used by women: the brassiere: But it was the American Mary Phelps Jacobs who in 1914 patented the brand with the name “backless brassiere” [27]. Since then, the bra has been an item of femininity that has been determining the specific and individual needs of women: comfort, function, need, fashion, seduction and price. Subsequently, the industry adapted the characteristics of the bra to the needs of each woman beyond fashion, innovating different types of bras for each type of chest and specifically for each situation: daily use, pregnancy, lactation, sport, parties, premenstrual state and therapeutic use per se. The ultimate goal is comfort and the avoidance of the emergence of diseases in the breast [28].

In this context, a controlled compression orthosis must meet the following conditions: 1) it must be moulded as if it were a second skin; 2) the compression must be uniform throughout the breast; 3) it must be very well adapted to the body, and not leave space or friction points; 4) it must be made with breathable and hypoallergenic fabric; and lastly, 5) it must be easy to put on and take off [22].

Therefore, its advantages are that it stabilises and immobilises the breast after any breast-conserving surgical operation and after plastic surgery; it favours the healing process, since it moderately compresses the area of the scar and benefits the lymphatic flow; it does not oppress or irritate the skin, thanks to the use of soft and hypoallergenic materials and its capacity for individual adaptation; and, in addition, it is easy to use for both the patient and the healthcare staff. All of the above give it therapeutic value per se and usefulness for reducing the functional limitation secondary to the surgical treatment of breast cancer [22-23].

Currently, there are several types of compression orthoses that meet the therapeutic expectations mentioned above.A comprehensive literature review in several repertoires (Medline, PubMed, Embase, Cochrane) has not allowed the authors to find studies that provide information on the relationship between the use of orthoses and the appearance of postoperative complications, and, as such, this would be a pioneering study in this field. In this context, as one of the few existing studies on bras and orthoses, in 2004 Sharon et al. [26] publishedthat postsurgical discomfort is reduced more when an adequate well-fitting bra is used instead of a tubular bandage, as a conclusion of their comparative study between both postoperative compression techniques, although without analysing the effects of the bra on postoperative complications.

The already published results of the CIR-ORT 2013 [22-23] clinical trial showed significant differences in the appearance of total and individual general complications (hematoma, seroma, breast oedema, pain intensity, skin lesions and functional limitation of the arm) depending on the use of orthoses or compressive dressings, with greater aesthetic satisfaction and quality of life being found with the use of the former. Thus, after 15 days, these differences become significant (P= .035), being 33% in favour of the orthosis in patients with lymphadenectomy and 15% in favour of the orthosis in patients without this intervention.

With the present study, we have tried to analyse this relationship and get to know better which factors are dependent on the management of these patients that are more related to the appearance of complications depending on the use of orthotics or a standard compressive dressing.

Among the data provided by this study, we can highlight the relationships between certain factors and the appearance of complications that can be reduced or modulated, at least theoretically, by the use of orthoses instead of the traditional compressive dressing. Thus the size and the cup of the bra, with three times the complications when using C/D/E cups versus A/B, a more exhaustive axillary dissection when necessary, with the risk of complications doubling for every 7 nodes removed, or the use of breast and axillary drainage, which would multiply by three the appearance of these complications, are management issues that should be considered when indicating the use of the dressing or orthosis in the period immediately following surgery.

More curious, although with fewer practical implications, would be finding a relationship between the intrinsic molecular subtype of the tumours and the emergence of complications. In fact, while the luminal profile A is associated with fewer complications, the HER2 neu profile duplicates them. In addition, this relationship persists after performing the multivariate analysis.

With a more general perspective, and from a practical point of view, it is very important that every woman recently operated on for breast cancer with conservative surgery, isable to participate in their social life and feel healthy, improve their quality of life and not be limited by the use of traditional compressive dressing. In this regard, the results coincide with those of Sharon et al. [29] and Gho et al. [30] and O’Hea et al. [31] on the importance of using tools that improve the quality of life of patients to reduce pain, seroma formation and in general the discomfort after conservative breast cancer surgery. It should be emphasised how the use of controlled compression orthoses that minimises the formation of blisters, a frequent adverse effect with the use of dressings that can be categorised as banal, is one of the most negatively assessed impacts by patients [22-23].

The interpretation of the statistical model has to be carried out from the perspective of the identification of postoperative complication predictive factors after breast cancer conservative surgery, since it would be necessary to have a larger sample size to replicate the model and adjust their confidence intervals for the odds ratios.

In conclusion, orthosis versus the traditional dressing in the compression procedure after conservative breast surgery is a protective predictor, and it therefore reduces general complications two weeks after the aforementioned surgery.

References

1. Arriagada R, Lê MG, Rochard F, et al. Conservative treatment versus mastectomy in early breast cancer: Patterns of failure with 15 years of follow-up data. InstitutGustave-Roussy Breast Cancer Group. J ClinOncol.1996; 14: 1558-64.

2. Veronesi U, Cascinelli N, Mariani L, et al. wenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002; 347: 1227-32.

3. Fisher B, Jeong J, Anderson S, et al. Twenty five year follow-up of a randomized trial comparing radical mastectomy, total mastectomy and total mastectomy followed by irradiation. N Engl J Med. 2002; 347:567–575.

4. Veronesi U, Stafyla V, Luini A, et al. Breast cancer: From ‘‘maximum tolerable’’ to ‘‘minimum effective’’ treatment. Front Oncol. 2012; 2: 125.

5. Kronowitz SJ, Hunt KK, Kuerer HM. Practical guidelines for repair of partial mastectomy defects using the breast reduction technique in patients undergoing breast conservation therapy. PlastReconstr Surg. 2007; 120: 1755–1768.

6. Marija A,Liberato C, Joseph G. The physical and psychological effects of breast reconstruction in breast cancer patients.A retrospective quantitative analysis between 2009 and 2011 at Mater Dei Hospital, Malta HellenikeCheirourgike.ActaChirurgicaHellenica. 2016; l: 79-84.

7. Acea-Nebril B, Cereijo-Garea C, García-Novoa A, et al. The role of oncoplastic breast reduction in the conservative management of breast cancer: Complications, survival, and quality of life. J SurgOncol.2017; 115: 679–686.

8. De León Carrillo J. Tratamientoquirúrgicodelcáncer de mama. En: Salvador Boffil J, Cuadernosmultidisciplinares de cáncer de mama. Ed. Saned. Madrid 2009; 69-81.

9. Krag DN, Anderson SJ, Julian TB, et al. Sentinel-lymph-node resection compared with conventional axillary-lymph-node dissection in clinically nodenegative patients with breast cancer: Overall survival findings from the NSABP B-32 randomised phase 3 trial. Lancet Oncol.2010; 11: 927-33.

10. O’Hea BJ, Ho MN, Petrek JA. External compressive dressing versus standard dressing after axillary lymphadenectomy.Am J Surg. 1999; 177: 450-3.

11. Eagle M. Compression bandaging. Nurs Stand. 200; 15: 47-52.

12. Lee YA, Hyun KJ, Tokura H. The effects of skin pressure by clothing on circadian rhythms of core temperature and salivary maltonin.Chronobiol Int. 2000; 17: 783-793.

13. Miyatsuji A, Matsumoto T, Mitarai S, et al. Effects of clothing pressure caused by different types of brassieres on autonomic nervous system activity evaluated by heart rate variability power spectral analysisJPhysiolAnthropolAppl Human Sci. 2002; 21: 67-74.

14. De Silva M. The costoclavicular syndrome: A “new cause”Ann Rheum Dis. 1986; 45: 916-920.

15. Mac Ghee DE, Steele JR. How do respiratory state and measurement method affect bra size calculations? Br J Sports Med. 2006; 40: 970-974.

16. Mentz HA. Ruiz-Razura A, Miniel LA. Correction of the bra strap shoulder groove deformity in women PlastReconstr Surg. 2007; 120: 2122-2123.

17. Wood K, Cameron M, Fitzgerald K. Breast size, bra fit and thoracic pain in young women: A correlational study.ChiroprOsteopat. 2008; 16: 1.

18. De León-Carrillo JM. Ortesispostoperatoria en patologíamamaria. Rev SenolPatolMamar., 2010; 23: 335-337

19. White J. Bra fitting criteria for bra selection a fitting in the UK. Ergonomics 2012; 55(6): 704-711.

20. Chan Ch J C, Yu W WM, Newton E. Evaluation and Analysis of bra design. The Design Journal 2015; 4 (3): 33-40.

21. Burbage J, Cameron L. An investigation into the prevalence and impact of breast pain, bra issues and breast size on female horse riders. J sports sci. 2017; 35:1091-97.

22. De Leon-Carrillo JM, Delgado C, De Castro G,et al. Estudiocomparativoaleatorizado de la utilidad de órtesis de compresióncontroladafrente al apósitocompresivo en el postoperatorioinmediato de la cirugíaconservadora del cáncer de mama. Rev SenolPatolMamar. 2016; 29(4): 150-156.

23. Cantero MJ,Galisteo R,Gata C,et al. Calidad de vida con órtesis de compresiónfrente a apósito en el postoperatorio de pacientes con cirugíaconservadora de cáncer de mama. Rev SenolPatolMamar. 2018;31(1): 20-30.

24. Sierra A, Fernández Ferrero F. Complicaciones de la cirugíamamaria. En: Sierra A, Piñero A, Illana J, editores. Cirugía de la mama. Madrid: Arán; 2006: 406-13.

25. CastelletFeliu E, Vidal N, Conesa X. Escalas de valoración en cirugíaortopédica y traumatología. Trauma Fund MAPFRE.2010; 21:34-43.

26. Vilagut G. Interpretación de los cuestionarios de salud SF-36 y SF-12 en España: componentesfísico y mental. Med Clin (Barc).2008;130:726-35

27. El sostén, Mitos y Leyendas. Manual de uso. Frances Puertas. Ed. Arcopress. Cordoba. 2012.

28. The bra-strap injury. Nanchahal J Br J Plast Surg. 2002; 55(5): 453-454.

29. Sharon L, Clark D, Harvey F. Patient preference for bra or binder after breast surgery. ANZ J Surg. 2004;7 4: 463-4.

30. O’Hea BJ, Ho MN, Petrek JA. External compressive dressing versus standard dressing after axillary lymphadenectomy.Am J Surg. 1999; 177: 450-3.

31. Gho SA, Munro BJ, Jones SC, Steele JR. Evidence-based recommendations for building better bras for a woman treated for breast cancer. Ergonomics.2014; 57: 774-8.

Received: July 27, 2018;
Accepted: August 11, 2018;
Published: August 14, 2018.

To cite this article : De León Carrillo JM, Delgado Jiménez C, Almeida González C.Compression Orthosis as Factor that Reduces Complications in Conservative Breast Cancer Surgery with Respect to the Use of a Compressive Dressing.British Journal of Cancer Research. 2018: 1:3.

© De León Carrillo JM, et al. 2018.