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Effectiveness of Lavage With Alcohol - Chlorhexidine for Chemical Matricectomy

Primary Purpose

Ingrown Toenail

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
70% alcohol
70% alcohol - 0.5% clorhexidine
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ingrown Toenail focused on measuring phenol, ingrown toenail, chemical matricectomy

Eligibility Criteria

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

Inclusion Criteria:

  • Older than 18 with onychocryptosis

Exclusion Criteria:

  • 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

Sites / Locations

  • Universidad Complutense de Madrid (Podología)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

alcohol - clorhexidine

70% alcohol

Arm Description

Ingrown toenail irrigated using 70% alcohol - 0.5% clorhexidine

Ingrown toenail irrigated using 70% alcohol

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
February 11, 2013
Last Updated
April 30, 2013
Sponsor
Universidad Complutense de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT01844141
Brief Title
Effectiveness of Lavage With Alcohol - Chlorhexidine for Chemical Matricectomy
Official Title
Effectiveness of the Lavage With 70% Alcohol Plus 0.5% Chlorhexidine Compared to 70% Alcohol for Chemical Matricectomy in the Surgical Treatment of Ingrown Toenails
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
April 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The purpose of this study is to compare the efficacy of the lavage with 70% alcohol plus 0.5% chlorhexidine versus 70% alcohol during the phenolization procedure in the surgical treatment of ingrown toenails in patients undergoing for chemical matricectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ingrown Toenail
Keywords
phenol, ingrown toenail, chemical matricectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
alcohol - clorhexidine
Arm Type
Experimental
Arm Description
Ingrown toenail irrigated using 70% alcohol - 0.5% clorhexidine
Arm Title
70% alcohol
Arm Type
Active Comparator
Arm Description
Ingrown toenail irrigated using 70% alcohol
Intervention Type
Drug
Intervention Name(s)
70% alcohol
Other Intervention Name(s)
Isopropilic alcohol., Ethanol
Intervention Description
After phenolization of the ingrown toenail the wound is irrigated with 15 cc solution of 70% alcohol plus 0.5% clorhexidine
Intervention Type
Drug
Intervention Name(s)
70% alcohol - 0.5% clorhexidine
Other Intervention Name(s)
chlorhexidine-gluconate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quantity of phenol recovered in each lavage with each solution
Description
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).
Time Frame
up to 2 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 with onychocryptosis Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ricardo Becerro de Bengoa Vallejo, PhD
Phone
(34)670678145
Email
ribebeva@enf.ucm.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo Becerro de Bengoa, Phd
Organizational Affiliation
Universidad Complutense de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad Complutense de Madrid (Podología)
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricardo Berceo, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
11231241
Citation
Plusje LG. Pincer nails: a new surgical treatment. Dermatol Surg. 2001 Jan;27(1):41-3.
Results Reference
background
PubMed Identifier
11277894
Citation
Baran R, Haneke E, Richert B. Pincer nails: definition and surgical treatment. Dermatol Surg. 2001 Mar;27(3):261-6.
Results Reference
background
PubMed Identifier
21621212
Citation
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.
Results Reference
result

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Effectiveness of Lavage With Alcohol - Chlorhexidine for Chemical Matricectomy

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