Efficacy of Intraoperative Surgical Scrubbing in Reducing Bacterial Load After Nail Removal Surgery

Phase 4

Completed

• Conditions: Skin Diseases; Nail Diseases; Nails, Ingrown
• Interventions: Drug: Polihexanide

• Registration Number: NCT01330706
• Lead Sponsor: Universidad Complutense de Madrid

Brief Summary

The investigators conducted a controlled, prospective randomized study to examine the antiseptic efficacy of intraoperative irrigation methods during nail avulsion surgery.

Detailed Description

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).

Study Timeline

• Status Verified: 2009-02
• Study Start: 2010-02
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Study First Submitted: 2011-04-01
• Study First Submitted QC: 2011-04-06
• Last Update Submitted: 2011-04-06
• Study First Posted: 2011-04-07
• Last Update Posted: 2011-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Older than 18
• Onychocryptosis

Exclusion Criteria

• infection
• a history of tinea pedis
• onychomycosis
• paronychia
• nail trauma or subungual hematoma
• nail deformities and disorders
• peripheral vascular disease or diabetes
• cardiac disease
• a history of rheumatic fever
• recent antibiotic use or current antimicrobial therapy
• a history of steroid use and
• recent nail polish use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sterile Saline solution	Polihexanide	The investigators compared intraoperative antiseptic irrigation using 0.9% saline solution and 0.1% polihexanide.

Primary Outcome Measures

Name	Time	Method
bacterial count (CFU/cm2)	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.

Trial Locations

Locations (1)

Universidad Complutense de Madrid; 🇪🇸 Madrid, Spain