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Use of Floseal and effects on wound healing and pain in adults undergoing tonsillectomy: randomised comparison versus electrocautery

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Abstract

The objective of this study was to evaluate the effect of FloSeal® (FS, Baxter Healthcare, Deerfield, IL, USA) as a haemostatic matrix in comparison to bipolar electrocautery (EC) after tonsillectomy. Eligible patients were adults undergoing cold-knife tonsillectomy because of recurrent tonsillitis, tonsillar hypertrophy, or peritonsillar abscess (more than 3 months previously). Patients were randomly allocated, on a single-blind basis, to either FS or EC for haemostasis during tonsillectomy. Five experienced surgeons judged the handling of FS application using a five-point scale (very good, good, fair, poor, very poor). Postoperative pain scores were evaluated with a visual analogue scale for 20 days, and the duration under pain medication together with the consumption of pain medication was compared. Wound healing was documented on Days 1–5, 10, and 20. A total of 176 patients were enrolled. Overall, 76/77 (98.7%) of surgeon evaluations of FS handling were judged at least “good”. FS-treated patients showed significantly improved wound healing (less thickness of wound plaques) throughout the postoperative observation period, a trend for less postoperative pain (cumulative pain intensity score; P = 0.074), and a significantly shorter duration of pain-medication use (9.5 vs. 11.6 days; P = 0.014) as well as reduced pain-medication consumption/demand (P = 0.032). No difference in the rate of postoperative haemorrhage was observed between the two treatment groups (4.9% for FS patients, 6.0% for EC patients, P = 0.76). In conclusion, this study demonstrates the easy handling of FS application in tonsillectomy. Its use instead of EC after cold-steel tonsillectomy shows beneficial effects on mucosal recovery, as assessed by a decrease in the thickness of wound coating. Furthermore, FS is associated with a significantly shortened duration of pain-medication use and overall reduction in consumption/demand.

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Acknowledgments

We especially thank the Coordination Centre of Clinical Trial, Leipzig (CCCTL) for the support in data management in all statistical questions and analysis. Editorial support for this manuscript was funded by Baxter and provided by Alpha-Plus Medical Communications Ltd.

Conflict of interest

This study was sponsored by Baxter, who provided the study medication (FloSeal). No further payments were received by the authors. The authors declare that they have no conflict of interest.

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Correspondence to Christian Mozet.

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Mozet, C., Prettin, C., Dietze, M. et al. Use of Floseal and effects on wound healing and pain in adults undergoing tonsillectomy: randomised comparison versus electrocautery. Eur Arch Otorhinolaryngol 269, 2247–2254 (2012). https://doi.org/10.1007/s00405-011-1904-4

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  • DOI: https://doi.org/10.1007/s00405-011-1904-4

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