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Completed

NCT Number: NCT01330706

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Universidad Complutense de Madrid

Madrid, 28040, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polihexanide

Drug

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Registry information

Acronym: ribebeva

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 7, 2011
Registry last updated
Apr 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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