BACKGROUND: We examined the efficacy and tolerability of Lavasept (polyhexamethylenbiguanid or PHMB)-an iodine-free antiseptic-in comparison to polyvinylpyrolidon iodine and Ringer's solution, as an alternative preoperative antiseptic. PATIENTS AND METHODS: In a randomized controlled double-blind trial 3 drops of Lavasept, 1.25%, PVP-iodine or Ringer's solution were applied preoperatively in 29 patients. The number of colony forming units (cfu) grown from conjunctival smears and conjunctival hyperaemia, corneal epitheliopathy and ocular surface pain were assessed preoperatively, intraoperatively and 1 day postoperatively. RESULTS: Despite intraoperative application of PVP-iodine, 40% of patients receiving Ringers solution still presented with more than 5 colony forming units (cfu) at the end of the procedure, while all patients that had additional preoperative Lavasept or PVP-iodine achieved relative sterility with less than 5 cfu (p < 0.05). While the effect of Lavasept lasted until the next day, conjunctival microbial colonisation recurred in eyes treated with PVP-iodine. As expected conjunctival hyperaemia and corneal epitheliopathy increased significantly postoperatively but no differences were observed between the 3 solutions tested. CONCLUSION: The preoperative application of Lavasept reduces the conjunctival flora safely and effectively. The microbicidal efficacy is equal to PVP-iodine, but potentially longer lasting. No signs of local or systemic intolerability were observed. Lavasept may be used as a potential alternative preoperative antiseptic and is suitable for iodine-intolerant patients.
RCT Entities:
BACKGROUND: We examined the efficacy and tolerability of Lavasept (polyhexamethylenbiguanid or PHMB)-an iodine-free antiseptic-in comparison to polyvinylpyrolidon iodine and Ringer's solution, as an alternative preoperative antiseptic. PATIENTS AND METHODS: In a randomized controlled double-blind trial 3 drops of Lavasept, 1.25%, PVP-iodine or Ringer's solution were applied preoperatively in 29 patients. The number of colony forming units (cfu) grown from conjunctival smears and conjunctival hyperaemia, corneal epitheliopathy and ocular surface pain were assessed preoperatively, intraoperatively and 1 day postoperatively. RESULTS: Despite intraoperative application of PVP-iodine, 40% of patients receiving Ringers solution still presented with more than 5 colony forming units (cfu) at the end of the procedure, while all patients that had additional preoperative Lavasept or PVP-iodine achieved relative sterility with less than 5 cfu (p < 0.05). While the effect of Lavasept lasted until the next day, conjunctival microbial colonisation recurred in eyes treated with PVP-iodine. As expected conjunctival hyperaemia and corneal epitheliopathy increased significantly postoperatively but no differences were observed between the 3 solutions tested. CONCLUSION: The preoperative application of Lavasept reduces the conjunctival flora safely and effectively. The microbicidal efficacy is equal to PVP-iodine, but potentially longer lasting. No signs of local or systemic intolerability were observed. Lavasept may be used as a potential alternative preoperative antiseptic and is suitable for iodine-intolerant patients.
Authors: K P Schmit-Neuerburg; C Bettag; W Schlickewei; W Fabry; J Hanke; K Renzing-Köhler; H Hirche; H J Kock Journal: Chirurg Date: 2001-01 Impact factor: 0.955