Effectiveness of Lavage With Alcohol - Chlorhexidine for Chemical Matricectomy

Ingrown Toenail Clinical Trial

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01844141
• Other study ID #: RIC11022013
• Status: Unknown status
• Phase: Phase 4
• First received: February 11, 2013
• Last updated: April 30, 2013
• Start date: January 2013
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Universidad Complutense de Madrid
• Contact: Ricardo Becerro de Bengoa Vallejo, PhD
• Phone: (34)670678145
• Email: ribebeva[@]enf.ucm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 40
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ingrown Toenail
• Nails, Ingrown

Intervention

Drug:
• 70% alcohol
After phenolization of the ingrown toenail the wound is irrigated with 15 cc solution of 70% alcohol plus 0.5% clorhexidine
• 70% alcohol - 0.5% clorhexidine
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.

Locations

Country	Name	City	State
Spain	Universidad Complutense de Madrid (Podología)	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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

Plusjé LG. Pincer nails: a new surgical treatment. Dermatol Surg. 2001 Jan;27(1):41-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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