Trial reportBMC cancer2019
Effect of topical microporous polysaccharide hemospheres on the duration and amount of fluid drainage following mastectomy: a prospective randomized clinical trial.
Trial report in BMC cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03647930 (The Effect of Arista on Post-Operative Bleeding and Wound Drainage Following Mastectomy), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Effect of Arista on Post-Operative Bleeding and Wound Drainage Following Mastectomy: A Prospective Randomized Trial
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.
- Prevention of lymphocele or seroma after mastectomy and axillary lymphadenectomy for breast cancer: systematic review and meta-analysis.Scientific reports · 2022Pooled it
- The Effect of Low and High Vacuum Drainage on the Postoperative Drainage of Breast Cancer: Insights from a Prospective, Non-Inferiority, Randomized Clinical Trial.Cancer management and research · 2020Trial
- Role of Absorbable Polysaccharide Hemostatic Powder in the Prevention of Complications After Axillary Lymph Node Dissection in Breast Cancer Patients: A Multicenter Retrospective Analysis.Medicina (Kaunas, Lithuania) · 2025Article
- Clinical effectiveness of microporous polysaccharide hemospheres in mastectomy for patients with breast cancer.Gland surgery · 2024Article
- Review of Evidence Supporting the Arista™ Absorbable Powder Hemostat.Medical devices (Auckland, N.Z.) · 2024Review
- Role of Absorbable Polysaccharide Hemostatic Powder in the Prevention of Bleeding and Wound Events after Thyroid Surgery.Journal of clinical medicine · 2023Article
- Porcine liver injury model to assess tantalum-containing bioactive glass powders for hemostasis.Journal of materials science. Materials in medicine · 2022Article
- Effect of microporous polysaccharide hemospheres on anterolateral thigh free flap donor site complications.Laryngoscope investigative otolaryngology · 2022Article
- Application and outlook of topical hemostatic materials: a narrative review.Annals of translational medicine · 2021Review
- Quilting suture is better than conventional suture with drain in preventing seroma formation at pectoral area after mastectomy.BMC surgery · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSeroma formation is the most common complication after mastectomy and places patients at risk of associated morbidities. Microporous polysaccharide hemospheres (MPH) consists of hydrophilic, plant based, polysaccharide particles and is currently used as an absorbable hemostatic agent. An animal model evaluating MPH and seroma formation after mastectomy with axillary lymph node dissection showed a significant decrease in seroma volume. Study aim was to evaluate topical MPH on the risk of post-mastectomy seroma formation as measured by total drain output and total drain days.
methodsProspective randomized single-blinded clinical trial of patients undergoing mastectomy for the treatment of breast cancer. MPH was applied to the surgical site in the study group and no application in the control group.
resultsFifty patients were enrolled; eight were excluded due to missing data. Forty-two patients were evaluated, control (n = 21) vs. MPH (n = 21). No difference was identified between the two groups regarding demographics, tumor stage, total drain days, total drain output, number of clinic visits, or complication rates. On a subset analysis, body mass index (BMI) greater than 30 was identified as an independent risk factor for high drain output. Post hoc analyses of MPH controlling for BMI also revealed no statistical difference.
conclusionsUnlike the data presented in an animal model, no difference was demonstrated in the duration and quantity of serosanguinous drainage related to the use of MPH in patients undergoing mastectomy for the treatment of breast cancer. BMI greater than 30 was identified as an independent risk factor for high drain output and this risk was not affected by MPH use. NCT03647930, retrospectively registered 08/2018.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.