Effectiveness of Lavage With Alcohol - Chlorhexidine for Chemical Matricectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Universidad Complutense de Madrid
Sponsor:
Information provided by (Responsible Party):
Ricardo Becerro de Bengoa Vallejo, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier:
NCT01844141
First received: February 11, 2013
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Ingrown Toenail
Drug: 70% alcohol
Drug: 70% alcohol - 0.5% clorhexidine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Universidad Complutense de Madrid:

Primary Outcome Measures:
  • Quantity of phenol recovered in each lavage with each solution [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: alcohol - clorhexidine
Ingrown toenail irrigated using 70% alcohol - 0.5% clorhexidine
Drug: 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.
Other Name: chlorhexidine-gluconate
Active Comparator: 70% alcohol
Ingrown toenail irrigated using 70% alcohol
Drug: 70% alcohol
After phenolization of the ingrown toenail the wound is irrigated with 15 cc solution of 70% alcohol plus 0.5% clorhexidine
Other Names:
  • Isopropilic alcohol.
  • Ethanol

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01844141

Contacts
Contact: Ricardo Becerro de Bengoa Vallejo, PhD (34)670678145 ribebeva@enf.ucm.es

Locations
Spain
Universidad Complutense de Madrid (Podología) Recruiting
Madrid, Spain, 28040
Principal Investigator: Ricardo Berceo, PhD         
Sponsors and Collaborators
Universidad Complutense de Madrid
Investigators
Principal Investigator: Ricardo Becerro de Bengoa, Phd Universidad Complutense de Madrid
  More Information

Publications:
Responsible Party: Ricardo Becerro de Bengoa Vallejo, PhD, Universidad Complutense de Madrid
ClinicalTrials.gov Identifier: NCT01844141     History of Changes
Other Study ID Numbers: RIC11022013
Study First Received: February 11, 2013
Last Updated: April 30, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by Universidad Complutense de Madrid:
phenol
ingrown toenail
chemical matricectomy

Additional relevant MeSH terms:
Nail Diseases
Nails, Ingrown
Skin Diseases
Ethanol
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on July 26, 2014