Prospective randomized controlled study to assess the value of a hemostatic and sealing agent for preventing seroma after axillary lymphadenectomy

Piñero-Madrona, Antonio; Castellanos-Escrig, Gregorio; Abrisqueta, Jesús; Canteras-Jordana, Manuel

doi:10.1002/jso.24344

Cited by 15 publications

(13 citation statements)

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“…One study was excluded from the analysis due to its retrospective nature [ 13 ]. At the end of the selection process, 23/223 (10.3%) screened studies met the inclusion criteria [ 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 ]. Figure 1 shows the PRISMA flow chart outlining the process of evidence acquisition.…”

Section: Resultsmentioning

confidence: 99%

“…Among them, 1884 (94.8%) patients had breast cancer; the remaining 103 and 1 patients were affected by melanoma and other cancers, and Hodgkin’s disease, respectively. In one of the series, one patient with Hodgkin’s disease underwent an axillary dissection [ 27 ]. The authors do not comment on the reason why they subjected the patient to this procedure.…”

Section: Resultsmentioning

confidence: 99%

“…When fibrin glue instillation under skin flaps was used to prevent lymphocele related morbidity following breast and axillary surgery, insufficient evidence to clearly assess the benefit on lymphocele rates and volume, complications, and length of hospital stay was achieved [ 52 ]. A more pronounced benefit was identified when non-liquid fibrin sealant devices (patches) were adopted in the same setting [ 24 , 26 , 27 ]. However, in a recent phase III clinical randomized trial, the application of fibrin sealant patches after ALND did not significantly reduce the total volume of axillary drainage.…”

Section: Discussionmentioning

confidence: 99%

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Fibrin Sealants and Axillary Lymphatic Morbidity: A Systematic Review and Meta-Analysis of 23 Clinical Randomized Trials

Gasparri

Kuehn

Ruscito

et al. 2021

Cancers

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Background: use of fibrin sealants following pelvic, paraaortic, and inguinal lymphadenectomy may reduce lymphatic morbidity. The aim of this meta-analysis is to evaluate if this finding applies to the axillary lymphadenectomy. Methods: randomized trials evaluating the efficacy of fibrin sealants in reducing axillary lymphatic complications were included. Lymphocele, drainage output, surgical-site complications, and hospital stay were considered as outcomes. Results: twenty-three randomized studies, including patients undergoing axillary lymphadenectomy for breast cancer, melanoma, and Hodgkin’s disease, were included. Fibrin sealants did not affect axillary lymphocele incidence nor the surgical site complications. Drainage output, days with drainage, and hospital stay were reduced when fibrin sealants were applied (p < 0.0001, p < 0.005, p = 0.008). Conclusion: fibrin sealants after axillary dissection reduce the total axillary drainage output, the duration of drainage, and the hospital stay. No effects on the incidence of postoperative lymphocele and surgical site complications rate are found.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Fibrin Sealants and Axillary Lymphatic Morbidity: A Systematic Review and Meta-Analysis of 23 Clinical Randomized Trials

Gasparri

Kuehn

Ruscito

et al. 2021

Cancers

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“…The reduction of dead space after surgery is one of those strategies that can be achieved through chemical ( 25 ) and/or mechanical means ( 26 , 27 ). Fibrin enriched compounds have shown seroma reduction in smaller studies, but this effect was lost in large randomized trials ( 23 , 24 , 26 , 28 ). Surgical glue has many uses, particularly in pediatric urogenital operations, to decrease incidence of hematomas, leak, and in the treatments of lymphocele ( 24 , 29 , 30 ).…”

Section: Introductionmentioning

confidence: 99%

“…No consensus exists despite numerous suggested strategies to reduce seroma formation including drains, buttress sutures, fibrin glue or patches, tetracycline sclerosing agents, methylprednisolone, somatostatin, and shoulder exercises (13,(15)(16)(17)(18)(19)(20)(21)(22)(23)(24).…”

Section: Introductionmentioning

confidence: 99%

Effectiveness of Cyanoacrylate in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection: A Randomized Controlled Trial

et al. 2021

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Background/PurposeSeroma is a common complication after axillary dissection in women with node-positive breast cancer. We aim to determine the effect of Cyanoacrylate on reducing seroma formation in patients undergoing axillary dissection. This a randomized clinical trial.MethodsThis is a single-center, randomized, single-blinded, and two-arm parallel study. Women with node-positive breast cancer eligible for axillary dissection were enrolled. Patients with a Body Mass Index (BMI) greater than 35 kg/m2, those who underwent immediate breast reconstruction, and/or received neoadjuvant chemotherapy were excluded. Patients were randomized in a 1:1 ratio, and were stratified according to their age, BMI, tumor size, and operation type. The primary endpoint was the total seroma volume (the total drained volume and the total aspirated volume after drain removal). Data presented as mean and range when applicable.Results111 patients were randomized (Cyanoacrylate 57; control 54). 105 patients were analyzed. Sixty-nine patients underwent breast conserving surgery, and 36 underwent modified radical mastectomy. There was no difference in the total seroma volume between the Cyanoacrylate vs. control arms (1,304 (60–4,950) vs. 1,446 (100–5,223) ml, p=0.458). Wound infection, flap necrosis, number of manual aspirates, and hematoma formation were not statistically different between the two groups. Time to drain removal was shorter in the Cyanoacrylate arm (11.04(3–23) vs. 13.84(3–37) days, p=0.015). The use of Cyanoacrylate was not cost effective ($586.93 (550–748) vs. $29.63 (0–198), p<0.001). Higher seroma volume was correlated with modified radical mastectomy, older age, and BMI more than 30 kg/m2.ConclusionCyanoacrylate did not reduce seroma formation and its use was not cost effective.Clinical Trial Registrationclinicaltrials.gov, identifier NCT02141373.

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Scientific surgery

2016

British Journal of Surgery

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et al. on behalf of the eTHoS study group. Comparison of stapled haemorrhoidopexy with traditional excisional surgery for haemorrhoidal disease (eTHoS): a pragmatic, multicentre, randomised controlled trial. Lancet 2016; 388: 2375-2385.Some 777 patients were included. The stapled procedure was less painful in the short term (6 weeks) but adverse event rates were similar. Standard surgery gave better quality of life over 24 months, P = 0⋅0342.

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Prospective randomized controlled study to assess the value of a hemostatic and sealing agent for preventing seroma after axillary lymphadenectomy

Abstract: Use of a collagen sponge coated with human coagulation factors following axillary lymphadenectomy was associated to a lower incidence of postoperative seroma. J. Surg. Oncol. 2016;114:423-427. © 2016 Wiley Periodicals, Inc.

Cited by 15 publications

References 45 publications

Fibrin Sealants and Axillary Lymphatic Morbidity: A Systematic Review and Meta-Analysis of 23 Clinical Randomized Trials

Fibrin Sealants and Axillary Lymphatic Morbidity: A Systematic Review and Meta-Analysis of 23 Clinical Randomized Trials

Effectiveness of Cyanoacrylate in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection: A Randomized Controlled Trial

Scientific surgery

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