Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000834550
Ethics application status
Approved
Date submitted
7/06/2015
Date registered
11/08/2015
Date last updated
11/08/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of the Technique of Orthonyxia on Ingrown Toenails.
Scientific title
Study of the Effectiveness of the Technique of Orthonyxia using Polyethylene Sheet for the Treatment of Onychocryptosis in Stage I and IIA on Nails with Pathological Curvatures.
Secondary ID [1] 286838 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Onychocryptosis 295224 0
Condition category
Condition code
Skin 295470 295470 0 0
Dermatological conditions
Surgery 295647 295647 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients were treated with the combination of the nail spicules cutting technique and the orthonyxia technique using polyethylene sheet. The intervention was carried out by a qualified podiatrist (researcher). The investigator had to cut the nail straight at the level of hyponychium. Then the researcher had to measure the nail width for patients receiving the intervention treatment (orthonyxia). The nail spicules cutting technique consisted of the removal of the portion of the nail that causes onychocryptosis, with the intention of releasing it from the soft parts. Using a number 15 scalpel or fine tip pliers this portion of the nail is then removed. This treatment was carried out at least on one occasion for all subjects enrolled into the study. If onychocryptosis recurred during the study period (12 months) the same procedure was performed again. The subjects were informed about making local cures with povidone-iodine once a day for a week. The orthonyxia technique consisted of the application of a flat polyethylene sheet of 0.5 millimeters in thickness which was glued onto the nail with cyanoacrylate. These sheets were replaced at three timepoints at minimum, baseline, 2, and 4 months. In case of accidental detachment or in case of appearing recurrence of onychocryptosis a new orthonyxia sheet was applied. Nail width measurement was performed at baseline, at 2, 4, 6 and 12 months.
Intervention code [1] 292000 0
Treatment: Surgery
Intervention code [2] 292141 0
Treatment: Devices
Comparator / control treatment
Patients treated only with the nail spicules cutting technique (described above).
Control group
Active

Outcomes
Primary outcome [1] 295254 0
The recurrence of the symptomatology of onychocryptosis (dichotomous nominal qualitative variable) has been measured objectively by direct observation of the own researcher and subjective form by the patient who had to notify the investigator at the time in which reappeared the symptomatology.
Timepoint [1] 295254 0
At the beginning of the study (before treatment), at 2 months, 4 months, 6 months and 12 months.
Primary outcome [2] 295255 0
The variable number of onychocryptosis recurrences (quantitative discrete variable) was created to account for the variable recurrence, and to evaluate the success rate of the two techniques used in the study. It has been measured using a scale of discrete quantitative measurement (0 recurrence, 1, 2, 3, 4...)
Timepoint [2] 295255 0
Since the beginning of the study up to 6 months (treatment period) and from 6 up to 12 months (follow-up period) and it has obtained the global number of onychocryptosis recurrences (total recurrences) computation by adding recurrence found in each of the periods.
Primary outcome [3] 295256 0
The variable width nail (quantitative continuous), has been used to evaluate the effectiveness of the technique of orthonyxia in the case of the study group, i.e., has been used to justify the change in blade nail or correction of the same. Has been measured in millimeters with a Vernier caliper digital model Powerfix Profi Z22855 (Registered Trademark).
Timepoint [3] 295256 0
At the beginning of the study (before treatment), 2, 4, 6 and 12 months.
Secondary outcome [1] 315205 0
Nil
Timepoint [1] 315205 0
Nil

Eligibility
Key inclusion criteria
Patients presenting onychocryptosis stage I or inflammation according to Mozena classification system, in which the nail fold does not exceed the limits of the nail plate and patients presenting onychocryptosis at IIA stage or abscess according to Mozena classification system, in which the nail fold exceeds the nail plate, with a size than 3 mm.
Patients presenting curvatures pathological nail number 1, 2, 5, 7, 8, 10, 11 and 12 of the Krausz scheme.
Minimum age
8 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with stage IIB onychocryptosis or superior according to Mozena classification system (the nail fold exceeds the limits of the nail plate, with size greater than 3 mm.), patients presenting pyogenic infection or mycosis, patients who submit hyperhidrosis and to undertake not to have a good hygiene and using astringent products, patients who do not go to query podiatric make nail cutting during the study period, patients who are not committed to avoid unsuitable footwear, patients allergic to cyanoacrylate.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample was calculated with an standard deviation equal to 1.5388, alpha equal to 0.05, beta equal to 0.01, the minimum interest of nail width difference equal to 1.3 mm., resulting in 43 patients for each group intervention. It was decided to include more subjects in each group to contemplate the possiility of usual "experimental death" in the investigations.
It is planned to used in the study of the statistical analysis the Statistical Package for Social Sciences (SPSS) version 17.0, a descriptive analysis of the data and an inferential analysis (the Kolmogorov-Smirnov test to determine the normality of variables, non-parametric tests: Mann-Whitney U test and Wilcoxon T test, and the Pearson correlation test for the study of the reliability of the measures).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/02/2012
Actual
21/02/2012
Date of last participant enrolment
Anticipated
Actual
27/07/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 6959 0
Spain
State/province [1] 6959 0
Seville

Funding & Sponsors
Funding source category [1] 291429 0
Self funded/Unfunded
Name [1] 291429 0
Salvador Marquez Reina
Country [1] 291429 0
Spain
Primary sponsor type
University
Name
University of Seville
Address
Avicena, S/N
41009
Seville
Country
Spain
Secondary sponsor category [1] 290105 0
None
Name [1] 290105 0
Address [1] 290105 0
Country [1] 290105 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292981 0
University of Seville Ethics Committee
Ethics committee address [1] 292981 0
Ethics committee country [1] 292981 0
Spain
Date submitted for ethics approval [1] 292981 0
Approval date [1] 292981 0
20/02/2012
Ethics approval number [1] 292981 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57742 0
Dr Salvador Marquez Reina
Address 57742 0
Clinica del pie Ntra. Sra. de la Oliva
Barriada Ntra. Sra. de la Oliva, 24 bajo B
41013
Seville
Country 57742 0
Spain
Phone 57742 0
+34 617660086
Fax 57742 0
Email 57742 0
[email protected]
Contact person for public queries
Name 57743 0
Salvador Marquez Reina
Address 57743 0
Clinica del pie Ntra. Sra. de la Oliva
Barriada Ntra. Sra. de la Oliva, 24 bajo B
41013
Seville
Country 57743 0
Spain
Phone 57743 0
+34 617660086
Fax 57743 0
Email 57743 0
[email protected]
Contact person for scientific queries
Name 57744 0
Salvador Marquez Reina
Address 57744 0
Clinica del pie Ntra. Sra. de la Oliva
Barriada Ntra. Sra. de la Oliva, 24 bajo B
41013
Seville
Country 57744 0
Spain
Phone 57744 0
+34 617660086
Fax 57744 0
Email 57744 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePolyethylene nail brace for ingrown toenails treatment: A randomized clinical trial.2020https://dx.doi.org/10.3390/ijerph17217741
N.B. These documents automatically identified may not have been verified by the study sponsor.