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

This study has been completed.
Sponsor:
Information provided by:
Universidad Complutense de Madrid
ClinicalTrials.gov Identifier:
NCT01330706
First received: April 1, 2011
Last updated: April 6, 2011
Last verified: February 2009

April 1, 2011
April 6, 2011
February 2010
March 2011   (final data collection date for primary outcome measure)
bacterial count (CFU/cm2) [ Time Frame: Participants will be followed until the surgery to heal completely,an expected average of 7 weeks ] [ Designated as safety issue: No ]

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.

Same as current
Complete list of historical versions of study NCT01330706 on ClinicalTrials.gov Archive Site
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Efficacy of Intraoperative Surgical Scrubbing in Reducing Bacterial Load After Nail Removal Surgery
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.

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).

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Skin Diseases
  • Nail Diseases
  • Nails, Ingrown
Drug: Polihexanide
The investigators compared intraoperative antiseptic irrigation using 0.9% saline solution and 0.1% polihexanide.
Experimental: Sterile Saline solution
The investigators compared intraoperative antiseptic irrigation using 0.9% saline solution and 0.1% polihexanide.
Intervention: Drug: Polihexanide
Becerro de Bengoa Vallejo R, Losa Iglesias ME, Cervera LA, Fernández 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. Epub 2010 Nov 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01330706
UCM 2011
Yes
Ricardo Becerro de Bengoa Vallejo, Universidad Complutense de Madrid
Universidad Complutense de Madrid
Not Provided
Principal Investigator: Ricado Becerro de Bengoa Vallejo, PhD Complutense University of Madrid
Universidad Complutense de Madrid
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP