NCT01844141

Brief Summary

To compare the efficacy of the lavage with 70% alcohol plus 0.5% chlorhexidine versus 70% alcohol in the surgical treatment of ingrown toenails.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 11, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 1, 2013

Completed
Last Updated

May 1, 2013

Status Verified

April 1, 2013

Enrollment Period

3 months

First QC Date

February 11, 2013

Last Update Submit

April 30, 2013

Conditions

Ingrown Toenail

Keywords

phenolingrown toenailchemical matricectomy

Outcome Measures

Primary Outcomes (1)

  • Quantity of phenol recovered in each lavage with each solution

    The amounts of phenol in the samples were quantified by a Jasco modular high performance liquid chromatograph HPLC (Jasco International Co Ltd, Japan) equipped with a LG-2080-04 quaternary low-gradient unit, a PU-2080 pump, a DG-2080-54 degasser, an AS-2050-plus autosampler and a UV-2070 plus UV/Vis detector was used. A C18 column Luna (particle size 3 µm, 150 x 4.6 mm) (Phenomenex, Torrance, CA, USA) was selected for the chromatographic separation of the components, adjusting the column temperature to 30 °C (LC Ni-II/ADC oven).

    up to 2 weeks

Study Arms (2)

alcohol - clorhexidine

EXPERIMENTAL

Ingrown toenail irrigated using 70% alcohol - 0.5% clorhexidine

Drug: 70% alcohol - 0.5% clorhexidine

70% alcohol

ACTIVE COMPARATOR

Ingrown toenail irrigated using 70% alcohol

Drug: 70% alcohol

Interventions

70% alcoholDRUG

After phenolization of the ingrown toenail the wound is irrigated with 15 cc solution of 70% alcohol plus 0.5% clorhexidine

Also known as: Isopropilic alcohol., Ethanol
70% alcohol
70% alcohol - 0.5% clorhexidineDRUG

In the intervention group five rounds of 3 ml wash of 70% alcohol - 0.5% clorhexidine was used to irrigate the exposed area of the nail to neutralize any residual effect of phenol and found out how much residual phenol is still in the wound.

Also known as: chlorhexidine-gluconate
alcohol - clorhexidine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older than 18 with onychocryptosis

You may not qualify if:

  • infection, history of tinea pedis, onychomycosis, paronychia, nail trauma or subungual hematoma, nail deformities and disorders, peripheral vascular disease or diabetes, cardiac disease, history of rheumatic fever, recent antibiotic use or current antimicrobial therapy, 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 (Podología)

Madrid, Madrid, 28040, Spain

RECRUITING

Related Publications (3)

  • Plusje LG. Pincer nails: a new surgical treatment. Dermatol Surg. 2001 Jan;27(1):41-3.

    PMID: 11231241BACKGROUND

  • Baran R, Haneke E, Richert B. Pincer nails: definition and surgical treatment. Dermatol Surg. 2001 Mar;27(3):261-6.

    PMID: 11277894BACKGROUND

  • Gao W, Legido-Quigley C. Fast and sensitive high performance liquid chromatography analysis of cosmetic creams for hydroquinone, phenol and six preservatives. J Chromatogr A. 2011 Jul 15;1218(28):4307-11. doi: 10.1016/j.chroma.2011.04.064. Epub 2011 May 6.

    PMID: 21621212RESULT

MeSH Terms

Conditions

Nails, Ingrown

Interventions

EthanolChlorhexidine

Condition Hierarchy (Ancestors)

Nail DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsBiguanidesGuanidinesAmidines

Study Officials

  • Ricardo Becerro de Bengoa, Phd

    Universidad Complutense de Madrid

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ricardo Becerro de Bengoa Vallejo, PhD

CONTACT

(34)670678145ribebeva@enf.ucm.es

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 11, 2013

First Posted

May 1, 2013

Study Start

January 1, 2013

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

May 1, 2013

Record last verified: 2013-04

Locations

ES(1)