Section: 
Diseases of the lymphoepithelial pharyngeal ring and neck
Diseases of the lymphoepithelial pharyngeal ring and neckEfficacy and safety of a new hemostatic device for adenoidectomy in children: results of a randomized clinical trial
M. V. Drozdova (1), S. V. Ryazantsev (2), L. E. Shapovalov (3), A. V. Andrianov (4), V. V. Turieva (5)
(1), (2), (3), (4), (5) Saint Petersburg Research Institute of Ear, Throat, Nose, and Speech, Saint Petersburg, 190013, Russian Federation, (2) Mechnikov North-Western State Medical University, Saint Petersburg, 191015, Russian Federation
UDK: 616.323-007.61-089.87-005.1-053.2:615.273.5
DOI: https://doi.org/10.18692/1810-4800-2026-4-8-18
ABSTRACT
Abstract. The article presents a clinical study of the efficacy and safety of a new domestic hemostatic product manufactured by Inmed LLC (Tech Specs 32.50.50 004 67539369 2017) during adenoidectomy in children. The product is a multilayer Z-shaped bandage with chitosan and highly dispersed silver (poviargol), where chitosan (N acetyl 1,4 ? D glucosamine) is the main active ingredient: its positively charged surface interacts with negatively charged erythrocyte membranes, forming a blood conglomerate and providing hemostasis. Objective. Comprehensive assessment of the efficacy and safety of using the medical product “Local sterile hemostatic agent for temporary arrest of external traumatic bleeding” (TU 32.50.50 004 67539369 2017) as a hemostatic agent during adenoidectomy in children. Patients and methods. Surgery was performed endoscopically using an adenotome (size 0–2). Hemostasis in the control group was achieved by nasopharyngeal tamponade with a gauze swab (1.5 ? 3.5–4.5 cm) soaked in a 3% hydrogen peroxide solution (exposure for 3 minutes), followed by bipolar coagulation of the bleeding areas with electrocautery. In the experimental group, a hemostatic device was used at the hemostasis stage: a tampon (size 3.25 cm for preschoolers, 4.25 cm for older children) was formed from a gauze drain (7.5 ? 160 cm) with an exposure of 180 seconds. The study population included 44 children aged 3 to 15 years with an established diagnosis of J35.2 — hypertrophy of the pharyngeal tonsil of grades II– III. Patients were randomly assigned to two groups: the main group, in which the device was used to ensure hemostasis, and the control group, where the traditional method with gauze drains was used. The required sample size was calculated in accordance with modern principles of clinical trial planning. Results. Analysis of data obtained during three consecutive visits convincingly confirms the advantage of the experimental method over the control technique in reducing the severity of key clinical symptoms of the disease. The indicators that significantly improved include: severity of edema; degree of hyperemia of the nasal and nasopharyngeal mucosa; amount and nature of discharge. The stability of the observed changes at all stages of monitoring and the high statistical significance of most differences (p < 0.001) indicate the reliability and reproducibility of the clinical effect of the experimental intervention. Conclusions. A conclusion is made about the high efficiency and safety of the device, its feasibility for implementation in pediatric practice for adenoidectomy: the method improves intra- and postoperative indicators, reduces the risk of complications and promotes faster recovery of patients.
Publication date:
08.08.2026
Keywords:
hemostasis, adenoidectomy in children, hemostatic product, Inmed LLC, chitosan (N acetyl 1,4 ? D glucosamine), pharyngeal tonsil hypertrophy, diagnosis J35.2, randomized trial, bipolar coagulation, postadenoidectomy blood loss, adenoidectomy duration, intraoperative adenoidectomy p For citation:
Drozdova M. V., Ryazantsev S. V., Shapovalov L. E., Andrianov A. V., Turieva V. V. Efficacy and safety of a new hemostatic device for adenoidectomy in children: results of a randomized clinical trial. Russian Otorhinolaryngology. 2026;25(4):8-18. (In Russ.) https://doi.org/10.18692/1810-4800-2026-4-8-18