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

Primary Purpose

Skin Diseases, Nail Diseases, Nails, Ingrown

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Polihexanide
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Skin Diseases focused on measuring Skin Diseases [C17.800], Nail Diseases [C17.800.529], Nails, Ingrown [C17.800.529.406]

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Universidad Complutense de Madrid

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sterile Saline solution

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 1, 2011
Last Updated
April 6, 2011
Sponsor
Universidad Complutense de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT01330706
Brief Title
Efficacy of Intraoperative Surgical Scrubbing in Reducing Bacterial Load After Nail Removal Surgery
Acronym
ribebeva
Official Title
Efficacy of Intraoperative Surgical Scrubbing in Reducing Bacterial Load After Nail Removal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Universidad Complutense de Madrid

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Diseases, Nail Diseases, Nails, Ingrown
Keywords
Skin Diseases [C17.800], Nail Diseases [C17.800.529], Nails, Ingrown [C17.800.529.406]

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sterile Saline solution
Arm Type
Experimental
Arm Description
The investigators compared intraoperative antiseptic irrigation using 0.9% saline solution and 0.1% polihexanide.
Intervention Type
Drug
Intervention Name(s)
Polihexanide
Intervention Description
The investigators compared intraoperative antiseptic irrigation using 0.9% saline solution and 0.1% polihexanide.
Primary Outcome Measure Information:
Title
bacterial count (CFU/cm2)
Description
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.
Time Frame
Participants will be followed until the surgery to heal completely,an expected average of 7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricado Becerro de Bengoa Vallejo, PhD
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Complutense de Madrid
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
21112671
Citation
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.
Results Reference
background
Links:
URL
http://www.ucm.es
Description
University Complutense de Madrid

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

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