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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01330706
First Posted: April 7, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Universidad Complutense de Madrid
  Purpose
The investigators conducted a controlled, prospective randomized study to examine the antiseptic efficacy of intraoperative irrigation methods during nail avulsion surgery.

Condition Intervention Phase
Skin Diseases Nail Diseases Nails, Ingrown Drug: Polihexanide Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Efficacy of Intraoperative Surgical Scrubbing in Reducing Bacterial Load After Nail Removal Surgery

Further study details as provided by Universidad Complutense de Madrid:

Primary Outcome Measures:
  • 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.



Enrollment: 50
Study Start Date: February 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sterile Saline solution
The investigators compared intraoperative antiseptic irrigation using 0.9% saline solution and 0.1% polihexanide.
Drug: Polihexanide
The investigators compared intraoperative antiseptic irrigation using 0.9% saline solution and 0.1% polihexanide.

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01330706


Locations
Spain
Universidad Complutense de Madrid
Madrid, Spain, 28040
Sponsors and Collaborators
Universidad Complutense de Madrid
Investigators
Principal Investigator: Ricado Becerro de Bengoa Vallejo, PhD Complutense University of Madrid
  More Information

Additional Information:
Publications:
Responsible Party: Ricardo Becerro de Bengoa Vallejo, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier: NCT01330706     History of Changes
Other Study ID Numbers: UCM 2011
First Submitted: April 1, 2011
First Posted: April 7, 2011
Last Update Posted: October 12, 2017
Last Verified: February 2009

Keywords provided by Universidad Complutense de Madrid:
Skin Diseases [C17.800]
Nail Diseases [C17.800.529]
Nails, Ingrown [C17.800.529.406]

Additional relevant MeSH terms:
Skin Diseases
Nail Diseases
Nails, Ingrown
Polihexanide
Disinfectants
Anti-Infective Agents