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.
Similar content being viewed by others
References
Maddern BR (2002) Electrosurgery for tonsillectomy. Laryngoscope 112:11–13
Gross WC, Gallagher R, Schloser RJ et al (2001) Autologous fibrin sealant reduces pain after tonsillectomy. Laryngoscope 11:259–263
Castellano P, Lopez-Escamaz JA (2003) American Society of Anesthesiology classification may predict severe post-tonsillectomy haemorrhage in children. J Otolaryngol 32:302–307
Randall DA, Hoffer ME (1998) Complications of tonsillectomy and adenoidectomy. Otolaryngol Head Neck Surg 118:61–68
Oz MC, Cosgrove DM, Badduke BR et al (2000) Controlled clinical trial of a novel hemostatic agent in cardiac surgery. Ann Thorac Surg 69:1376–1382
Jacobs JB (2001) Innovative techniques: use of FloSeal in endoscopic sinus surgery: operative techniques. Otolaryngol Head Neck Surg 12:83–84
Mathiasen RA, Cruz R (2004) Prospective, randomized, controlled clinical trial of a novel matrix hemostatic sealant in children undergoing adenoidectomy. Laryngoscope 131:601–605
Jo SH, Mathiasen RA, Gurushanthaiah D (2007) Prospective, randomized, controlled trial of a hemostatic sealant in children undergoing adenotonsillectomy. Otolaryngol Head Neck Surg 137:454–458
Huskisson EC (1974) Measurement of pain. Lancet 2:1227–1231
Silvola J, Salonen A, Nieminen J, Kokki H (2011) Tissue welding tonsillectomy provides an enhanced recovery compared to that after monopolar electrocautery technique in adults: a prospective randomized clinical trial. Eur Arch Otorhinolaryngol 268:255–260
Mitic S, Tvinnereim M, Lie E, Saltyte BJ (2007) A pilot randomized controlled trial of coblation tonsillectomy versus dissection tonsillectomy with bipolar diathermy haemostasis. Clin Otolaryngol 32:261–267
Wilson YSL, Merer DM, Moscatello AL (2009) Comparison of three common tonsillectomy techniques: a prospective randomized double-blinded clinical study. Laryngoscope 119:162–170
Gallagher TQ, Wilcox L, McGuire E, Derkay CS (2010) Analyzing factors associated with major complications after adenotonsillectomy in 4776 patients: comparing three tonsillectomy techniques. Otolaryngol Head Neck Surg 142:886–892
Apfelbaum JL, Chen C, Mehta SS, Gan T (2003) Postoperative pain experience: results from a national survey suggests postoperative pain continues to be undermanaged. Anesth Analg 97:534–540
Baumann A, Caversaccio M (2004) Hemostasis in endoscopic sinus surgery using a specific gelatine-thrombin based agent (FloSeal). Rhinology 41:244–249
Mann KG (1999) Biochemistry physiology of blood coagulation. Thromb Haemost 82:165–174
Dorion RP, Hamati HF, Landis B, Frey C, Heydt D, Carey D (1998) Risk and clinical significance of developing antibodies induced by topical thrombin preparations. Arch Pathol Lab Med 122:887–894
Neschis DG, Heyman MR, Cheanvechai V, Benja min ME, Flinn WR (2002) Coagulopathy as a result of factor V inhibitor after exposure to bovine topical thrombin. J Vasc Surg 35:400–402
19th Association of University Hospitals of Germany (2009) Tonsillectomy hemorrhage. In: Quality of life-art medicine of the German Academic Medicine, Berlin, pp 24–25
Windfuhr JP, Schloendorff G, Baburi D, Kremer B (2008) Lethal outcome of post-tonsillectomy hemorrhage. Eur Arch Otorhinolaryngol 265:1527–1534
Stoeckli SJ, Moe KS, Huber A, Schmid S (1999) A prospective randomized double-blind trial of fibrin glue for pain and bleeding after tonsillectomy. Laryngoscope 109:652–655
Blackmore KJ, O`Hara J, Flood LM, Martin FW (2008) The effect of FloSeal on postoperative pain: a randomised controlled pilot study. Clin Otolaryngol 33:265–284
Toma AG, Blanshard J, Eynon-Lewis N, Bridger MW (1995) Post-tonsillectomy pain: the first ten days. J Laryngol Otol 109:963–964
Jorgensen S, Bascom DA, Partsafa A, Wax MK (2003) The effect of 2 sealants (FloSeal and Tisseel) on fasciocutaneous flap revascularization. Arch Facial Plast Surg 5:399–401
Attner P, Hemlin C, Söderman AC (2010) Ligasure versus diathermy scissors tonsillectomy: a controlled randomized study. Acta Otolaryngol 130:1180–1184
Werner MU, Duun P, Kehlet H (2004) Prediction of postoperative pain by preoperative nociceptive responses to heat stimulation. Anesthesiology 100:115–119
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.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
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
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00405-011-1904-4