Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 140
Filtrar
1.
Breast Cancer Res Treat ; 203(2): 187-196, 2024 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-37878150

RESUMO

PURPOSE: Up to 40% of the 56,000 women diagnosed with breast cancer each year in the UK undergo mastectomy. Seroma formation following surgery is common, may delay wound healing, and be uncomfortable or delay the start of adjuvant treatment. Multiple strategies to reduce seroma formation include surgical drains, flap fixation and external compression exist but evidence to support best practice is lacking. We aimed to survey UK breast surgeons to determine current practice to inform the feasibility of undertaking a future trial. METHODS: An online survey was developed and circulated to UK breast surgeons via professional and trainee associations and social media to explore current attitudes to drain use and management of post-operative seroma. Simple descriptive statistics were used to summarise the results. RESULTS: The majority of surgeons (82/97, 85%) reported using drains either routinely (38, 39%) or in certain circumstances (44, 45%). Other methods for reducing seroma such as flap fixation were less commonly used. Wide variation was reported in the assessment and management of post-operative seromas. Over half (47/91, 52%) of respondents felt there was some uncertainty about drain use after mastectomy and axillary surgery and two-thirds (59/91, 65%) felt that a trial evaluating the use of drains vs no drains after simple breast cancer surgery was needed. CONCLUSIONS: There is a need for a large-scale UK-based RCT to determine if, when and in whom drains are necessary following mastectomy and axillary surgery. This work will inform the design and conduct of a future trial.


Assuntos
Neoplasias da Mama , Mastectomia , Feminino , Humanos , Mastectomia/efeitos adversos , Seroma/epidemiologia , Seroma/etiologia , Seroma/terapia , Neoplasias da Mama/cirurgia , Drenagem , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/terapia
2.
Ann Plast Surg ; 91(3): 331-336, 2023 09 01.
Artigo em Inglês, Alemão | MEDLINE | ID: mdl-37347178

RESUMO

BACKGROUND: Seroma is a relatively common complication after breast reconstruction with tissue expanders. The main risk in the presence of seroma is development of periprosthetic infection, which can lead to implant loss. Our goals were to identify risk factors for seroma, and to describe our protocol for managing fluid accumulation. PATIENTS AND METHODS: An IRB approved breast reconstruction database was reviewed to identify patients who underwent tissue expander reconstruction. Patient characteristics, details of surgery, outcomes and treatment were recorded. RESULTS: Two hundred nineteen tissue expander reconstructions were performed in 138 patients. Twenty-eight reconstructions developed seroma (12.8%), and 75 were identified to have prolonged drains (34.2%). Seroma was more common in patients with lymph node surgery ( P = 0.043), delayed reconstruction ( P = 0.049), and prepectoral reconstruction ( P = 0.002). Seroma and/or prolonged drains were more commonly noted in patients with higher body mass index ( P = 0.044) and larger breast size ( P = 0.001). Aspiration was the most common intervention (85.7%), which was performed in the clinic utilizing the expander port site. There was no difference in infection or explantation rate between seroma and no-seroma patients ( P = 0.546 and 0.167), whereas patients with any fluid concern (seroma and/or prolonged drains) were more prone to developing infection and undergoing explantation ( P = 0.041 and P < 0.005). CONCLUSION: We recommend that prolonged drain placement longer than 3 weeks should be avoided, and patients should be screened for fluid accumulation after drain removal. Serial aspiration via expander port site and continuation of expansion provide a safe and effective method to manage seromas to avoid infection and expander loss.


Assuntos
Implantes de Mama , Neoplasias da Mama , Mamoplastia , Humanos , Feminino , Dispositivos para Expansão de Tecidos/efeitos adversos , Estudos Retrospectivos , Mamoplastia/efeitos adversos , Mamoplastia/métodos , Drenagem/efeitos adversos , Expansão de Tecido/efeitos adversos , Expansão de Tecido/métodos , Seroma/epidemiologia , Seroma/etiologia , Seroma/terapia , Neoplasias da Mama/complicações , Implantes de Mama/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/cirurgia
3.
J Am Acad Orthop Surg ; 31(17): 908-913, 2023 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-37071898

RESUMO

Fluid collections after spine surgery are rare complications, although potentially grave, and may be broadly grouped into two major categories. Symptomatic postoperative epidural hematomas have some known risk factors and can present with a widely variable profile of signs and symptoms. Treatment involves emergent surgical evacuation to reduce the risk of permanent neurologic deficit. Postoperative seroma may lead to disruption of wound healing and deep infection and has been associated with the use of recombinant human bone mineral protein. These diagnoses may present diagnostic challenges; thorough understanding of the involved pathophysiology, meticulous clinical evaluation, and radiographic interpretation are critical to appropriate management and optimal outcome.


Assuntos
Seroma , Doenças da Medula Espinal , Humanos , Seroma/terapia , Seroma/complicações , Estudos Retrospectivos , Coluna Vertebral/cirurgia , Hematoma/etiologia , Doenças da Medula Espinal/etiologia , Complicações Pós-Operatórias/cirurgia
4.
Int Wound J ; 20(4): 1183-1190, 2023 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-36251756

RESUMO

We conducted a meta-analysis to compare the effectiveness of negative pressure wound drainage to that of spontaneous wound drainage after thyroid tumour surgery. A thorough analysis of the literature up to July 2022 revealed that, of the 1234 patients who used surgery for thyroid tumours, 615 used negative pressure wound drainage and 619 used natural wound drainage. To measure the influence of negative pressure wound drainage in comparison to natural wound drainage following thyroid tumour surgery, mean difference (MD) and odds ratio (OR) with 95% confidence intervals (CIs) were measured using the contentious and dichotomous approaches with a random or fixed-effect model. Subjects who used negative pressure wound drainage had significantly higher averages for drained material (OR, 12.52; 95% CI, 6.78-18.26, P = 0.001), shorter drain placement times (MD, -1.06; 95% CI, 1.57 to -0.55, P = .001), lower rates of infection at the surgical site (OR, 0.17; 95% CI, 0.05-0.60, P = .006), higher rates of wound healing (OR, 5.91; 95% CI, 1.56-22.34, P = .009), and lower rate of wound seroma (OR, 0.21; 95% CI, 0.10-0.42, P < .001) in subjects after thyroid tumour surgery in comparison to subjects who used natural wound drainage after thyroid tumour surgery. Those who used negative pressure wound drainage had significantly higher averages of drained material, shorter drain placement times, lower rates of wound infection at the surgical site, higher rates of wound healing, and lower rates of wound seroma. Care must be used when analysing the results because of the small sample size of 7 of the 13 studies included in the meta-analysis and the lack of studies in several comparisons.


Assuntos
Seroma , Neoplasias da Glândula Tireoide , Humanos , Seroma/etiologia , Seroma/terapia , Neoplasias da Glândula Tireoide/cirurgia , Drenagem , Razão de Chances , Cicatrização
5.
Plast Reconstr Surg ; 151(1): 20e-30e, 2023 01 01.
Artigo em Inglês | MEDLINE | ID: mdl-36194076

RESUMO

SUMMARY: The breast implant capsule is a dynamic structure that forms following the implantation of a device. Although normally benign, increased awareness of breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) highlights that disease may arise from the capsule. BIA-ALCL presents as a late seroma or mass but explains few of the late seromas found in breast implant patients. To date, many of these seromas lack a clear cause and are often described as "idiopathic." Several benign and malignant breast implant capsular diseases can cause a late seroma or mass, including breast implant-associated squamous cell carcinoma. Similar to early reports of BIA-ALCL, these conditions are rare and largely limited to case reports or series. The purpose of this special topic is to present a narrative review highlighting capsular abnormalities that contribute to the formation of late seroma or mass in an attempt to broaden the differential diagnosis and help plastic surgeons identify the cause. Specifically, we review the presentation and management of BIA-ALCL, synovial metaplasia, capsular epithelialization, late hematoma, double capsule, breast cancer, squamous cell carcinoma, mesenchymal tumor, and B-cell lymphoma. Although rare, plastic surgeons should consider these capsular conditions as causes of late seromas and masses. Usually, these conditions may be diagnosed by following the National Comprehensive Cancer Network screening guidelines for BIA-ALCL. Thorough evaluation and workup of late seromas and masses may lead to improved characterization of these rare breast implant capsular conditions and improve our understanding of their pathophysiology and management.


Assuntos
Implante Mamário , Implantes de Mama , Neoplasias da Mama , Linfoma Anaplásico de Células Grandes , Humanos , Feminino , Linfoma Anaplásico de Células Grandes/diagnóstico , Linfoma Anaplásico de Células Grandes/etiologia , Linfoma Anaplásico de Células Grandes/terapia , Implantes de Mama/efeitos adversos , Seroma/diagnóstico , Seroma/etiologia , Seroma/terapia , Implante Mamário/efeitos adversos , Mama/cirurgia , Neoplasias da Mama/etiologia , Neoplasias da Mama/cirurgia , Neoplasias da Mama/diagnóstico
6.
Adv Skin Wound Care ; 35(7): 1-6, 2022 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-35723961

RESUMO

OBJECTIVE: To evaluate the safety of compressive taping in patients with seroma secondary to breast cancer surgery. METHODS: This study was a nonrandomized clinical study of medical devices applied to women indicated for seroma aspiration puncture after breast cancer surgery in a public reference hospital in Brazil. The intervention consisted of applying compressive taping over the seroma fluctuation area and maintained for 5 days. Evaluated outcomes comprised dermal changes caused by taping, subjective symptoms reported during the intervention period, and percent change in the punctured volume before and after the intervention. RESULTS: A total of 35 women (mean age, 56.7 ± 12.2 years) were included. Most presented with an advanced disease stage (≥IIB; 62.9%). Although a 28.6% incidence of dermal changes caused by taping was observed, an average reduction in the aspirated volume of -28.2 mL was identified (95% confidence interval, -48.3 to -8.0; P = .008). Treatment adherence was high (91.4%), and most patients reported satisfaction with the treatment (85.7%). CONCLUSIONS: The use of compressive taping on seroma areas can be considered safe, is well accepted by patients, and might be used as a noninvasive treatment option for seroma developing after breast cancer surgery.


Assuntos
Neoplasias da Mama , Seroma , Adulto , Idoso , Neoplasias da Mama/epidemiologia , Neoplasias da Mama/etiologia , Neoplasias da Mama/cirurgia , Drenagem , Feminino , Humanos , Incidência , Excisão de Linfonodo/efeitos adversos , Pessoa de Meia-Idade , Seroma/epidemiologia , Seroma/etiologia , Seroma/terapia
7.
Acta Clin Croat ; 60(3): 548-551, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-35282498

RESUMO

Abdominoplasty is one of the most popular aesthetic body contouring procedures. Seroma formation is the most common early complication after abdominoplasty. Usually, it resolves with punctions and seroma evacuation. Chronic seroma and pseudocyst formation is a rare complication and it demands surgical intervention. Based on our experience from the described case, the pseudocyst needs to be radically extirpated and a combination of quilting sutures, fibrin glue, three weeks of suction drainage, and compressive garments should be used to prevent recurrence.


Assuntos
Abdominoplastia , Abdominoplastia/efeitos adversos , Adesivo Tecidual de Fibrina , Humanos , Seroma/prevenção & controle , Seroma/terapia , Suturas/efeitos adversos
8.
Int Wound J ; 19(6): 1578-1593, 2022 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-35112467

RESUMO

The application of negative pressure wound therapy (NPWT) in cancer surgical wounds is still controversial, despite its promising usage, because of the risks of increased tumorigenesis and metastasis. This study aimed to review the risks and benefits of NPWT in surgical wounds with the underlying malignant disease compared with conventional wound care (CWC). The first outcome was wound complications, divided into surgical site infection (SSI), seroma, hematoma, and wound dehiscence. The secondary outcome was hospital readmission. We performed a separate meta-analysis of observational studies and randomised controlled trials (RCTs) with CI 95%. Thirteen observational studies with 1923 patients and seven RCTs with 1091 patients were included. NPWT group showed significant decrease in the risk of SSI (RR = 0.45) and seroma (RR = 0.61) in observational studies with P value <0.05, as well as RCTs but were not significant (RR = 0.88 and RR = 0.68). Wound dehiscence (RR = 0.74 and RR = 1.15) and hospital readmission (RR = 0.90 and RR = 0.62) showed lower risks in NPWT group but were not significant. Hematoma (RR = 1.08 and RR = 0.87) showed no significant difference. NPWT is not contraindicated in cancer surgical wounds and can be considered a beneficial palliative treatment to promote wound healing.


Assuntos
Tratamento de Ferimentos com Pressão Negativa , Neoplasias , Ferida Cirúrgica , Hematoma , Humanos , Neoplasias/cirurgia , Ensaios Clínicos Controlados Aleatórios como Assunto , Seroma/etiologia , Seroma/terapia , Ferida Cirúrgica/terapia , Deiscência da Ferida Operatória/terapia , Infecção da Ferida Cirúrgica/terapia
10.
Ugeskr Laeger ; 183(46)2021 11 15.
Artigo em Dinamarquês | MEDLINE | ID: mdl-34796864

RESUMO

Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) is a serious complication in patients with breast implants. In this case report, a 38-year-old woman who was diagnosed with BIA-ALCL presented with seroma in her left breast eight years after her breast implantation surgery. The purpose of this case report is to draw attention to the fact that "late-onset" seroma in patients with breast implants can be a sign of malignancy. A multidisciplinary approach in the diagnosis and treatment of these patients is important. Manifestations, investigation and management of the disease are reviewed.


Assuntos
Implante Mamário , Implantes de Mama , Linfoma Anaplásico de Células Grandes , Adulto , Implante Mamário/efeitos adversos , Implantes de Mama/efeitos adversos , Feminino , Humanos , Linfoma Anaplásico de Células Grandes/diagnóstico , Linfoma Anaplásico de Células Grandes/etiologia , Linfoma Anaplásico de Células Grandes/terapia , Mastectomia , Seroma/diagnóstico por imagem , Seroma/etiologia , Seroma/terapia
11.
Aesthet Surg J ; 41(11): NP1543-NP1549, 2021 10 15.
Artigo em Inglês | MEDLINE | ID: mdl-34347042

RESUMO

This article introduces a new technology to minimize seroma and promote more predictable healing in surgically created deep space wounds. Its novel design internalizes the delivery of a continuously generated high negative pressure (-125 mmHg) throughout the surgically created space by means of a multibranched Manifold. In a small prospective cohort case study of 24 patients undergoing full abdominoplasty, all patients underwent placement of this device, which was removed 7 days postoperatively. Results at 30 days revealed no evidence of wound-healing problems, no clinical seroma, and no device malfunction. The internalization of a constant negative-pressure wound therapy provided by this system has the potential to significantly reduce clinical seroma, and to produce more consistent apposition of interfaces in deep tissue spaces in complex wounds seen in plastic surgery and other surgical disciplines.


Assuntos
Abdominoplastia , Tratamento de Ferimentos com Pressão Negativa , Humanos , Estudos Prospectivos , Seroma/etiologia , Seroma/terapia , Cicatrização
13.
Plast Reconstr Surg ; 147(2): 345-354, 2021 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-33565825

RESUMO

BACKGROUND: As the leading complication of abdominoplasty, seroma formation might represent an inflammatory process in response to surgical trauma. This prospective randomized trial investigated whether local administration of the antiinflammatory agent triamcinolone could prevent seroma accumulation. METHODS: Weekly and cumulative seroma volumes were compared between the study groups A, B, and C over a 4-week follow-up (group A, with drain, without triamcinolone; group B, without drain, without triamcinolone; group C, without drain, with triamcinolone). Aspirated seroma samples were analyzed by enzyme-linked immunosorbent assay for selective inflammatory mediators. RESULTS: Triamcinolone significantly reduced cumulative seroma volume (n = 60; mA 845 ± SDA 578 ml, mC 236 ± SDC 381 ml, p = 0.001). The most accentuated suppressive effect of triamcinolone was observed shortly after the treatment (week 1) (mA1 616 ± SDA1 457 ml, mB1 153 ± SDB1 161 ml, mC1 22 ± SDC1 44 ml, pA1/C1 < 0.001, pB1/C1 = 0.014). Local triamcinolone administration resulted in a differential concentration of interleukin-6 (IL-6) and matrix metalloproteinase-9 (MMP-9 (week 1) in seroma exudate as measured by enzyme-linked immunosorbent assay (mIL-6A1 1239 ± SDA1 59 pg/ml, mIL-6C1 848 ± SDC1 80 pg/ml, p < 0.001; mMMP-9A1 2343 ± SDA1 484 pg/ml, mMMP-9C1 376 ± SDC1 120 pg/ml, p = 0.001). CONCLUSIONS: Local administration of 80 mg of triamcinolone reduced postabdominoplasty seroma accumulation significantly. Under triamcinolone treatment, suppressed levels of IL-6 and MMP-9 in seroma fluid were observed. Notably, inflammatory marker suppression correlated clinically with a decrease in seroma accumulation. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.


Assuntos
Abdominoplastia/efeitos adversos , Anti-Inflamatórios/administração & dosagem , Drenagem/métodos , Seroma/terapia , Triancinolona/administração & dosagem , Adulto , Terapia Combinada/métodos , Ensaio de Imunoadsorção Enzimática , Exsudatos e Transudatos/química , Exsudatos e Transudatos/diagnóstico por imagem , Exsudatos e Transudatos/efeitos dos fármacos , Exsudatos e Transudatos/imunologia , Feminino , Seguimentos , Humanos , Interleucina-6/análise , Interleucina-6/imunologia , Masculino , Metaloproteinase 9 da Matriz/análise , Metaloproteinase 9 da Matriz/imunologia , Pessoa de Meia-Idade , Complicações Pós-Operatórias , Estudos Prospectivos , Seroma/diagnóstico , Seroma/etiologia , Irrigação Terapêutica/métodos , Resultado do Tratamento , Ultrassonografia
14.
J Plast Reconstr Aesthet Surg ; 74(9): 2251-2257, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-33582049

RESUMO

BACKGROUND AND PURPOSE: Seromas are a common and unavoidable complication following lymphadenectomy, and often become clinically significant with superseded infection requiring re-admission for prompt intervention. However, there is no consensus as to whether a formal surgical incision and drainage (I&D), ultrasound (US)-guided aspiration or intravenous (IV) antibiotics alone is the most efficacious method of managing an infected seroma, the investigation of which formed the rationale for this study. SUBJECTS AND METHODS: This retrospective cohort study included a consecutive series of patients readmitted for infected seroma following a lymphadenectomy for melanoma at Leeds Teaching Hospitals Trust (LTHT) from 2006 to 2017. Details on management, length of hospital stay, length of follow-up and number of clinical appointments required were examined. FINDINGS: Seventy-one cases of infected seroma were identified from the cohort of 1691 lymphadenectomies. Initially, 21 patients (29.5%) were managed by IV antibiotics alone (failure rate of 52.4%); 18 (25.4%) with US-guided aspiration (failure rate 27.8%) and 32 (45.1%) with surgical I&D, which was 100% effective. Ultimately, 62.5% of the cohort required surgical management. Patients who underwent surgical I&D were discharged significantly faster following the procedure (3 versus 5 days for US-guided aspiration, p = 0.002) and spent fewer days in hospital overall (p = 0.022). The overall average cost was comparable across the three treatment groups. CONCLUSIONS: Surgical management seemed preferential to conservative approaches in terms of efficacy and was not significantly more expensive overall; but carries anaesthetic risk. There may be a clinically significant difference in outcome depending on management; however, more evidence is required to investigate this.


Assuntos
Excisão de Linfonodo , Metástase Linfática/patologia , Melanoma/patologia , Complicações Pós-Operatórias/microbiologia , Complicações Pós-Operatórias/cirurgia , Seroma/microbiologia , Seroma/terapia , Neoplasias Cutâneas/patologia , Antibacterianos/uso terapêutico , Feminino , Humanos , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos
15.
BMJ Case Rep ; 14(1)2021 Jan 18.
Artigo em Inglês | MEDLINE | ID: mdl-33462032

RESUMO

Morel-Lavallée lesion is a chronic, recurrent collection of serous fluid in the soft tissues and usually occurs following injury. The most common sites are thigh, hip and pelvic region. This presents as a local or diffuse swelling and may cause discomfort to the patient besides being a potential site for bacterial contamination. So, early diagnosis and timely management is crucial for an early and successful outcome. The investigation modality of choice for diagnosis of these lesions is MRI. Definitive management ranges from percutaneous aspiration with or without sclerotherapy to open debridement and irrigation. Although recurrences are common with conservative management, it can be minimised with judicious use of sclerotherapy.


Assuntos
Antibacterianos/administração & dosagem , Doxiciclina/administração & dosagem , Escleroterapia , Seroma/diagnóstico , Seroma/etiologia , Coxa da Perna/lesões , Acidentes por Quedas , Desbridamento , Drenagem , Feminino , Humanos , Seroma/terapia , Adulto Jovem
18.
Artigo em Inglês | MEDLINE | ID: mdl-33105793

RESUMO

Growing evidence indicates that physical activity (PA) interventions may reduce upper limb function-limiting side effects of treatments and improve quality of life (QoL) of breast cancer (BC) survivors. However, the possible effectiveness of PA in cases developing seroma after BC treatment has yet to be demonstrated. Here, we describe for the first time the impact of a structured PA pathway (i.e., two cycles of eight-week adapted PA followed by eight-week adapted fitness) on upper limb disability and QoL in a peculiar case of chronic seroma as complication of reconstructive plastic surgery after left breast mastectomy and lymphadenectomy. A 56-year-old female BC survivor underwent a functional test battery (i.e., shoulder-arm mobility, range of motion, back flexibility and indirect assessment of pectoralis minor muscle) at baseline, during and after ending the structured PA pathway. Upper limb and back pain intensity and QoL were evaluated by numerical rating scale and Short Form-12 questionnaire, respectively. A relevant seroma reduction, an improvement in upper limb mobility and pain perception, and an overall increase in QoL were achieved after the structured PA intervention. Our findings suggest that an adapted PA intervention may represent an effective strategy for seroma treatment in BC survivors.


Assuntos
Neoplasias da Mama , Terapia por Exercício , Excisão de Linfonodo , Qualidade de Vida , Seroma , Neoplasias da Mama/cirurgia , Terapia por Exercício/normas , Feminino , Humanos , Excisão de Linfonodo/efeitos adversos , Excisão de Linfonodo/reabilitação , Pessoa de Meia-Idade , Seroma/etiologia , Seroma/terapia , Extremidade Superior/cirurgia
19.
BMC Cancer ; 20(1): 735, 2020 Aug 07.
Artigo em Inglês | MEDLINE | ID: mdl-32767988

RESUMO

BACKGROUND: Seroma formation is a common complication after breast cancer surgery and can lead to delayed wound healing, infection, patient discomfort and repeated visits to the outpatient clinic. Mastectomy combined with flap fixation is becoming standard practice and is currently combined with closed-suction drainage. There is evidence showing that closed-suction drainage may be insufficient in preventing seroma formation. There is reasonable doubt whether there is still place for closed-suction drainage after mastectomy when flap fixation is performed. We hypothesize that mastectomy combined with flap fixation and closed suction drainage does not cause a significant lower incidence of seroma aspirations, when compared to mastectomy and flap fixation alone. Furthermore, we expect that patients without drainage will experience significantly less discomfort and comparable rates of surgical site infections. METHODS: This is a randomized controlled trial in female breast cancer patients undergoing mastectomy and flap fixation using sutures with or without sentinel lymph node biopsy (SLNB). Patients will be eligible for inclusion if they are older than 18 years, have an indication for mastectomy with or without sentinel procedure. Exclusion criteria are modified radical mastectomy, direct breast reconstruction, previous history of radiation therapy of the unilateral breast, breast conserving therapy and inability to give informed consent. A total of 250 patients will be randomly allocated to one of two groups: mastectomy combined with flap fixation and closed-suction drainage or mastectomy combined with flap fixation without drainage. Follow-up will be conducted up to six months postoperatively. The primary outcome is the proportion of patients undergoing one or more seroma aspirations. Secondary outcome measures consist of the number of invasive interventions, surgical site infection, quality of life measured using the SF-12 Health Survey, cosmesis, pain and number of additional outpatient department visits. DISCUSSION: To our knowledge, no randomized controlled trial has been conducted comparing flap fixation with and without closed-suction drainage with seroma aspiration as the primary outcome. This study could result in finding evidence that supports performing mastectomy without closed-suction drainage. TRIAL REGISTRATION: This trial was approved by the medical ethical committee of Zuyderland Medical Center METC-Z on 20 March 2019 (METCZ20190023). The SARA Trial was registered at ClinicalTrials.gov as per July 2019, Identifier: NCT04035590 .


Assuntos
Mastectomia/métodos , Complicações Pós-Operatórias/terapia , Seroma/terapia , Retalhos Cirúrgicos/transplante , Adulto , Feminino , Humanos , Mastectomia/efeitos adversos , Países Baixos , Avaliação de Resultados em Cuidados de Saúde , Complicações Pós-Operatórias/etiologia , Tamanho da Amostra , Biópsia de Linfonodo Sentinela , Seroma/etiologia , Sucção , Técnicas de Sutura
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...