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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

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

NCT ID

NCT01330706

First Posted

April 1, 2011

Last Updated

April 6, 2011

Sponsor

Universidad Complutense de Madrid

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

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

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

Learn more about this trial

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

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