Abstract
Purpose
The purpose of the study is to compare the results of single-blind a randomized controlled trial on the use of the local hemostatic agent Haemoblock and ultrasound monitoring of postoperative wounds in patients after the large incisional hernias repair.
Methods
The study represented a single-blind randomized controlled trial. The total number of patients was 66. Group with Haemoblock (A) and the Group without Haemoblock (B) included 33 patients each. Operation—sublay retromuscular repair with mesh prolene implant. We applied Haemoblock 15 ml retromuscularly and 15 ml subcutaneousely in group A. Wounds were drained by vacuum suction drainage. Postoperatively – ultrasound monitoring of postoperative wounds.
Results
Median of follow-up was 33 days. Significant differences were obtained in the duration of wound draining, 2.6 ± 0.6 days in group A versus 4.1 ± 0.9 days in group B (p = 0.002). In group A, the levels of C-reactive protein and albumin were less in the separated discharge, as well as its total amount. During the first 12 days, a significantly lower volume of fluid collections was detected in patients of group A than in patients of group B. We noted a more rapid subsidence of exudative processes in postoperative wounds in patients from group A. The number of punctures was significantly higher in group B (0.8 ± 1.0 vs. 0.2 ± 0.4, respectively, p = 0.003). The total number of puncture interventions in group A was six in six patients, versus 27 in 14 patients in group B (p = 0.000).
Conclusion
The use of the local hemostatic agent Haemoblock can reduce the duration of the postoperative wound draining, shorten the period of inflammatory exudative processes in the postoperative wound, significantly reduce the number of puncture interventions for the postoperative wound, reduce the risk of the seromas formation and surgical site infections (SSI) associated with seroma, reduce the severity of pain and the need for analgesics.
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No funding was received for conducting this trial.
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END—Original idea, preparation of the manuscript, critical revision of the manuscript; PVK—Original idea, data analysis, preparation of the manuscript, critical revision of the manuscript, data collection and follow-up of patients; VPK—critical revision of the manuscript, data collection and follow-up of patients, clinical study leader; AVS—critical revision of the manuscript.
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This study was approved by the Local Ethical Committee of Omsk state Medical University (protocol № 99 oт 14.12.2017) and the study was conducted according to the ethical standards of the Helsinki Declaration of 1975.
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Informed consent was obtained from all individual participants included in the study after detail explanation of possible complications. Patients were then given at least 24 h for consideration of participating in the clinical trial before the operation.
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Degovtsov, E.N., Kolyadko, P.V. & Kolyadko, V.P. Using local hemostatic to prevent seromas in patients with large incisional hernias randomized controlled trial. Hernia 25, 441–448 (2021). https://doi.org/10.1007/s10029-020-02251-1
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DOI: https://doi.org/10.1007/s10029-020-02251-1