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

NCT ID: NCT01330706

Last Updated: 2011-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-03-31

Brief Summary

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The investigators conducted a controlled, prospective randomized study to examine the antiseptic efficacy of intraoperative irrigation methods during nail avulsion surgery.

Detailed Description

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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).

Conditions

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Skin Diseases Nail Diseases Nails, Ingrown

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Sterile Saline solution

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

Group Type EXPERIMENTAL

Polihexanide

Intervention Type DRUG

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

Interventions

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Polihexanide

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Universidad Complutense de Madrid

Principal Investigators

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Ricado Becerro de Bengoa Vallejo, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Complutense de Madrid

Locations

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Universidad Complutense de Madrid

Madrid, Madrid, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 21112671 (View on PubMed)

Related Links

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http://www.ucm.es

University Complutense de Madrid

Other Identifiers

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UCM 2011

Identifier Type: -

Identifier Source: org_study_id

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