Clinical Trial: Efficacy of Intraoperative Surgical Scrubbing in Reducing Bacterial Load After Nail Removal Surgery
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Efficacy of Intraoperative Surgical Scrubbing in Reducing Bacterial Load After Nail Removal Surgery
Brief Summary: The investigators conducted a controlled, prospective randomized study to examine the antiseptic efficacy of intraoperative irrigation methods during nail avulsion surgery.
Detailed Summary: The investigators conducted a controlled, prospective randomized study to examine the antiseptic efficacy of intraoperative scrubbing methods during nail avulsion surgery. The investigators compared intraoperative antiseptic scrubbing using 0.9% saline solution and 0.1% polihexanide. Swab samples were taken from each patient at 5 distinct stages throughout the surgical procedure, and bacterial culture analysis was performed (positive culture rate, total inocula count, reduction of bacterial load, and identification of specific microorganisms).
Sponsor: Universidad Complutense de Madrid
Current Primary Outcome: bacterial count (CFU/cm2) [ Time Frame: Participants will be followed until the surgery to heal completely,an expected average of 7 weeks ]
The percentage of inoculum reduction at the irrigation step was calculated as follows: percentage of inoculum reduction = 100 e (1003 Ii)/Is, where Ii is the bacterial count (CFU/cm2) at the irrigation step and Is is the inoculum (CFU/cm2) at the surgery step.
Bacteria were identified using standard laboratory methods. The limit of detection in the nailfold test was 1.33 CFU/cm2.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Universidad Complutense de Madrid
Dates:
Date Received: April 1, 2011
Date Started: February 2010
Date Completion:
Last Updated: April 6, 2011
Last Verified: February 2009