Efficacy of Intraoperative Surgical Scrubbing in Reducing Bacterial Load After Nail Removal Surgery
ribebeva
1 other identifier
interventional
50
1 country
1
Brief Summary
The investigators conducted a controlled, prospective randomized study to examine the antiseptic efficacy of intraoperative irrigation methods during nail avulsion surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2010
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 1, 2011
CompletedFirst Posted
Study publicly available on registry
April 7, 2011
CompletedApril 7, 2011
February 1, 2009
1.1 years
April 1, 2011
April 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
bacterial count (CFU/cm2)
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.
Participants will be followed until the surgery to heal completely,an expected average of 7 weeks
Study Arms (1)
Sterile Saline solution
EXPERIMENTALThe investigators compared intraoperative antiseptic irrigation using 0.9% saline solution and 0.1% polihexanide.
Interventions
The investigators compared intraoperative antiseptic irrigation using 0.9% saline solution and 0.1% polihexanide.
Eligibility Criteria
You may qualify if:
- Older than 18
- Onychocryptosis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universidad Complutense de Madrid
Madrid, Madrid, 28040, Spain
Related Publications (1)
Becerro de Bengoa Vallejo R, Losa Iglesias ME, Cervera LA, Fernandez DS, Prieto JP. Efficacy of intraoperative surgical irrigation with polihexanide and nitrofurazone in reducing bacterial load after nail removal surgery. J Am Acad Dermatol. 2011 Feb;64(2):328-35. doi: 10.1016/j.jaad.2010.01.011. Epub 2010 Nov 26.
PMID: 21112671BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ricado Becerro de Bengoa Vallejo, PhD
Universidad Complutense de Madrid
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 1, 2011
First Posted
April 7, 2011
Study Start
February 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
April 7, 2011
Record last verified: 2009-02