CLINICAL TRIAL
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Topic usage of kaolin-impregnated gauze as a hemostatic in tonsillectomy.

BACKGROUND: The main postoperative complications after tonsillectomy are due to bleeding, and effective hemostasis may lead to a reduction of overall postoperative morbidity. This study was undertaken to determine the efficacy and safety of a novel kaolin-based hemostatic dressing in tonsillectomy.

METHODS: A pilot, single-blind, open label study was performed in patients aged 3-20 y with history of chronic or hypertrophic tonsillitis. Cold dissection tonsillectomy (CDT) + ligature was performed by the same surgeon. Hemostasis on each tonsillar fossa was achieved using kaolin-impregnated gauze (KG; study group) or standard surgical cotton gauze (CG; control). Time to complete hemostasis, operative time, intraoperative blood loss, pain score, analgesic use, and return to normal diet and activity were recorded for all children.

RESULTS: A total of 230 patients with a mean age of 8.0 y (138 in the study group and 92 in the control group) were included in the study. Both operative time and intraoperative blood loss were significantly reduced in the KG group (P < 0.0001) versus the CG group. At 5 min, 84.8% patients using the KG successfully achieved complete hemostasis versus 34.8% in the CG group where standard gauze controlled bleeding only partially. Results show significantly less pain for the KG group at 6- and 12-h postoperative when compared with the CG group (P < 0.0001). Also, the KG group required less analgesic medications, returned to normal diet and normal activities faster than the CG group (P < 0.01).

CONCLUSIONS: Preliminary findings show that the KG is effective and safe in managing surgical bleeding after tonsillectomy. In addition to rapid bleeding control, the dressing causes minimal inflammation and pain and allows patients to quickly return to normal activities. This novel dressing is a promising tool for ear, nose and throat surgical hemostasis.

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