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1.
Breast Cancer Res Treat ; 203(2): 187-196, 2024 Jan.
Article de Anglais | MEDLINE | ID: mdl-37878150

RÉSUMÉ

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.


Sujet(s)
Tumeurs du sein , Mastectomie , Femelle , Humains , Mastectomie/effets indésirables , Sérome/épidémiologie , Sérome/étiologie , Sérome/thérapie , Tumeurs du sein/chirurgie , Drainage , Complications postopératoires/épidémiologie , Complications postopératoires/étiologie , Complications postopératoires/thérapie
2.
Ann Plast Surg ; 91(3): 331-336, 2023 09 01.
Article de Anglais, Allemand | MEDLINE | ID: mdl-37347178

RÉSUMÉ

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.


Sujet(s)
Implants mammaires , Tumeurs du sein , Mammoplastie , Humains , Femelle , Expanseurs tissulaires/effets indésirables , Études rétrospectives , Mammoplastie/effets indésirables , Mammoplastie/méthodes , Drainage/effets indésirables , Expansion tissulaire/effets indésirables , Expansion tissulaire/méthodes , Sérome/épidémiologie , Sérome/étiologie , Sérome/thérapie , Tumeurs du sein/complications , Implants mammaires/effets indésirables , Complications postopératoires/épidémiologie , Complications postopératoires/étiologie , Complications postopératoires/chirurgie
3.
J Am Acad Orthop Surg ; 31(17): 908-913, 2023 Sep 01.
Article de Anglais | MEDLINE | ID: mdl-37071898

RÉSUMÉ

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.


Sujet(s)
Sérome , Maladies de la moelle épinière , Humains , Sérome/thérapie , Sérome/complications , Études rétrospectives , Rachis/chirurgie , Hématome/étiologie , Maladies de la moelle épinière/étiologie , Complications postopératoires/chirurgie
4.
Int Wound J ; 20(4): 1183-1190, 2023 Apr.
Article de Anglais | MEDLINE | ID: mdl-36251756

RÉSUMÉ

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.


Sujet(s)
Sérome , Tumeurs de la thyroïde , Humains , Sérome/étiologie , Sérome/thérapie , Tumeurs de la thyroïde/chirurgie , Drainage , Odds ratio , Cicatrisation de plaie
5.
Plast Reconstr Surg ; 151(1): 20e-30e, 2023 01 01.
Article de Anglais | MEDLINE | ID: mdl-36194076

RÉSUMÉ

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.


Sujet(s)
Implantation de prothèse mammaire , Implants mammaires , Tumeurs du sein , Lymphome à grandes cellules anaplasiques , Humains , Femelle , Lymphome à grandes cellules anaplasiques/diagnostic , Lymphome à grandes cellules anaplasiques/étiologie , Lymphome à grandes cellules anaplasiques/thérapie , Implants mammaires/effets indésirables , Sérome/diagnostic , Sérome/étiologie , Sérome/thérapie , Implantation de prothèse mammaire/effets indésirables , Région mammaire/chirurgie , Tumeurs du sein/étiologie , Tumeurs du sein/chirurgie , Tumeurs du sein/diagnostic
6.
Adv Skin Wound Care ; 35(7): 1-6, 2022 Jul 01.
Article de Anglais | MEDLINE | ID: mdl-35723961

RÉSUMÉ

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.


Sujet(s)
Tumeurs du sein , Sérome , Adulte , Sujet âgé , Tumeurs du sein/épidémiologie , Tumeurs du sein/étiologie , Tumeurs du sein/chirurgie , Drainage , Femelle , Humains , Incidence , Lymphadénectomie/effets indésirables , Adulte d'âge moyen , Sérome/épidémiologie , Sérome/étiologie , Sérome/thérapie
7.
Acta Clin Croat ; 60(3): 548-551, 2022 Feb.
Article de Anglais | MEDLINE | ID: mdl-35282498

RÉSUMÉ

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.


Sujet(s)
Abdominoplastie , Abdominoplastie/effets indésirables , Colle de fibrine , Humains , Sérome/prévention et contrôle , Sérome/thérapie , Matériaux de suture/effets indésirables
8.
Int Wound J ; 19(6): 1578-1593, 2022 Oct.
Article de Anglais | MEDLINE | ID: mdl-35112467

RÉSUMÉ

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.


Sujet(s)
Traitement des plaies par pression négative , Tumeurs , Plaie opératoire , Hématome , Humains , Tumeurs/chirurgie , Essais contrôlés randomisés comme sujet , Sérome/étiologie , Sérome/thérapie , Plaie opératoire/thérapie , Lâchage de suture/thérapie , Infection de plaie opératoire/thérapie
10.
Ugeskr Laeger ; 183(46)2021 11 15.
Article de Danois | MEDLINE | ID: mdl-34796864

RÉSUMÉ

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.


Sujet(s)
Implantation de prothèse mammaire , Implants mammaires , Lymphome à grandes cellules anaplasiques , Adulte , Implantation de prothèse mammaire/effets indésirables , Implants mammaires/effets indésirables , Femelle , Humains , Lymphome à grandes cellules anaplasiques/diagnostic , Lymphome à grandes cellules anaplasiques/étiologie , Lymphome à grandes cellules anaplasiques/thérapie , Mastectomie , Sérome/imagerie diagnostique , Sérome/étiologie , Sérome/thérapie
11.
Aesthet Surg J ; 41(11): NP1543-NP1549, 2021 10 15.
Article de Anglais | MEDLINE | ID: mdl-34347042

RÉSUMÉ

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.


Sujet(s)
Abdominoplastie , Traitement des plaies par pression négative , Humains , Études prospectives , Sérome/étiologie , Sérome/thérapie , Cicatrisation de plaie
13.
Plast Reconstr Surg ; 147(2): 345-354, 2021 02 01.
Article de Anglais | MEDLINE | ID: mdl-33565825

RÉSUMÉ

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.


Sujet(s)
Abdominoplastie/effets indésirables , Anti-inflammatoires/administration et posologie , Drainage/méthodes , Sérome/thérapie , Triamcinolone/administration et posologie , Adulte , Association thérapeutique/méthodes , Test ELISA , Exsudats et transsudats/composition chimique , Exsudats et transsudats/imagerie diagnostique , Exsudats et transsudats/effets des médicaments et des substances chimiques , Exsudats et transsudats/immunologie , Femelle , Études de suivi , Humains , Interleukine-6/analyse , Interleukine-6/immunologie , Mâle , Matrix metalloproteinase 9/analyse , Matrix metalloproteinase 9/immunologie , Adulte d'âge moyen , Complications postopératoires , Études prospectives , Sérome/diagnostic , Sérome/étiologie , Irrigation thérapeutique/méthodes , Résultat thérapeutique , Échographie
14.
J Plast Reconstr Aesthet Surg ; 74(9): 2251-2257, 2021 Sep.
Article de Anglais | MEDLINE | ID: mdl-33582049

RÉSUMÉ

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.


Sujet(s)
Lymphadénectomie , Métastase lymphatique/anatomopathologie , Mélanome/anatomopathologie , Complications postopératoires/microbiologie , Complications postopératoires/chirurgie , Sérome/microbiologie , Sérome/thérapie , Tumeurs cutanées/anatomopathologie , Antibactériens/usage thérapeutique , Femelle , Humains , Durée du séjour/statistiques et données numériques , Mâle , Adulte d'âge moyen , Études rétrospectives
15.
BMJ Case Rep ; 14(1)2021 Jan 18.
Article de Anglais | MEDLINE | ID: mdl-33462032

RÉSUMÉ

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.


Sujet(s)
Antibactériens/administration et posologie , Doxycycline/administration et posologie , Sclérothérapie , Sérome/diagnostic , Sérome/étiologie , Cuisse/traumatismes , Chutes accidentelles , Débridement , Drainage , Femelle , Humains , Sérome/thérapie , Jeune adulte
18.
Article de Anglais | MEDLINE | ID: mdl-33105793

RÉSUMÉ

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.


Sujet(s)
Tumeurs du sein , Traitement par les exercices physiques , Lymphadénectomie , Qualité de vie , Sérome , Tumeurs du sein/chirurgie , Traitement par les exercices physiques/normes , Femelle , Humains , Lymphadénectomie/effets indésirables , Lymphadénectomie/rééducation et réadaptation , Adulte d'âge moyen , Sérome/étiologie , Sérome/thérapie , Membre supérieur/chirurgie
19.
BMC Cancer ; 20(1): 735, 2020 Aug 07.
Article de Anglais | MEDLINE | ID: mdl-32767988

RÉSUMÉ

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 .


Sujet(s)
Mastectomie/méthodes , Complications postopératoires/thérapie , Sérome/thérapie , Lambeaux chirurgicaux/transplantation , Adulte , Femelle , Humains , Mastectomie/effets indésirables , Pays-Bas , , Complications postopératoires/étiologie , Taille de l'échantillon , Biopsie de noeud lymphatique sentinelle , Sérome/étiologie , Aspiration (technique) , Techniques de suture
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