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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01330706

Acronym

ribebeva

Enrollment

Registered

2011-04-07

Start date

2010-02-28

Completion date

2011-03-31

Last updated

2011-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nail Diseases, Nails, Ingrown, Skin Diseases

Keywords

Skin Diseases [C17.800], Nail Diseases [C17.800.529], Nails, Ingrown [C17.800.529.406]

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).

Interventions

DRUGPolihexanide

The investigators compared intraoperative antiseptic irrigation using 0.9% saline solution and 0.1% polihexanide.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026