Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001719123
Ethics application status
Approved
Date submitted
7/05/2019
Date registered
5/12/2019
Date last updated
5/12/2019
Date data sharing statement initially provided
5/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Cauterization of the germinal nail matrix using phenol applications of 30 or 60": A randomized double-blind clinical trial.
Scientific title
Cauterization of the germinal nail matrix using phenol applications of 30 or 60" in patients with onychocryptosis: A randomized double-blind clinical trial.
Secondary ID [1] 297644 0
Nil Known
Universal Trial Number (UTN)
U1111-1229-6389
Trial acronym
FAP30-60
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Onychocryptosis 311918 0
Condition category
Condition code
Surgery 310506 310506 0 0
Other surgery
Skin 310507 310507 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The same clinician (Dr. Pedro Montaño Jiménez) carried out all the surgical procedures of the hallux with a duration of 60 minutes. First, a digital blocking of the hallux using 2% of Mepivacaine in subcutaneous injection, after a surgical scrubbing of the operatory field, a digital tourniquet was done for the local hemostasis of the hallux; prior marking with a dermographic pencil of the portion of the nail lamina to be extracted. The nail plate affected was separated from the nail bed and the eponychium with a free hoist. after removing the portion of the nail plate, a swab with a cotton ball soaked in 88% phenol was applied for 30 seconds to the zone of the matrix and the nail bed. This zone was irrigated with 76% ethanol for 1 minute and then with a physiological saline solution. The surgical wounds were covered with a thin layer of sulfadiazine silver cream 1% and after with non-stick absorbent sterile polypropylene. Gauze was placed around the hallux and covered with a sterile compressive bandage.
Intervention code [1] 313878 0
Treatment: Surgery
Comparator / control treatment
For the control group, the segmentary phenolization was applied for 60 seconds to the zone of the matrix and the nail bed.
Control group
Active

Outcomes
Primary outcome [1] 319362 0
Healing time paying attention to the previously described criteria. These criteria are: absence of exudate in the gauze; the forming of a scab which covers the granulation tissue; the wound must be kept uncovered; a lack of signs of infection or inflammation in the zone operated; there are no signs of erythematosus tissue or of hypergranulation. This outcome was assessed by clinical examination and digital photography.
Timepoint [1] 319362 0
Period of time between the surgical action and the solving of the draining and/or inflammatory changes. The frequency of assessment of the corresponding outcome was every week for up to 6 months.
Primary outcome [2] 319363 0
Recurrence. A relapse of clinical reappearance (pain, inflammation, erythema and /or infection). This outcome was assessed by clinical examination and digital photography.
Timepoint [2] 319363 0
Single assessment at 6 months post-surgery.
Secondary outcome [1] 367906 0
Pain. 100mm visual analogue scale.
Timepoint [1] 367906 0
24, 48 and 72 hours after intervention.
Secondary outcome [2] 367907 0
Infection. Presence of infection was considered when there was pain and clinical drainage, or pus secretion with erythema was noted. This outcome was assessed by clinical examination and digital photography.
Timepoint [2] 367907 0
72 hours after intervention.
Secondary outcome [3] 367908 0
Bleeding. The indicator was classified as mild when this partially stains the cellulose dressing and the gauze, as moderate when it totally stains the dressing and partially the gauze in contact, and abundant when it stains the dressing and much of the gauzes, and the bleeding is visible.
Timepoint [3] 367908 0
72 hours after intervention.

Eligibility
Key inclusion criteria
Onychocryptosis in stages I or IIa, not having an underlying bone pathology, an indication of partial matricectomy.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
To have chronic illnesses, to be pregnant, to be sensitive to phenol, or to have had previous onychocryptosis surgery. Presence of serious circulatory problems, or badly controlled Diabetes, and not having wound healing disorders.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization was intraoperatory via tossing a coin in the air.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Patients have censorship that prevents them from seeing surgical treatment.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The sample size required for the study was calculated using GRANMO v 7.12 online software for two independent measures. Accepting a alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 23 nail folds per group were required to detect a difference of 7 days, estimating a follow-up loss rate of 10%. SPSS 17.0. (SPSS, Inc., Chicago, IL) was used for the statistical analysis. A first exploratory analysis was done to characterize the differences between the subgroups of patients. The quantitative variables were expressed through their averages and standard deviations; the qualitative variables in percentages and 95% confidence intervals. The Kolmogorov–Smirnov and Saphiro Wilk tests for normality were applied. The healing time, recurrence and infection were measured by nail edges and the bleeding and pain variables by toes. The mild and moderate categories were combined for the statistical analysis of the bleeding variable. The Chi-square test with Yates continuity correction was applied to the contingency tables two by two of the recurrence, bleeding and infection variables for the comparison between the groups. The Mann-Whitney U test for non-normal distributions compared the healing time (in days) and pain (analogical visual scale) variables. A statistically significant difference was considered between the groups when the value of p is less than 0,05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/01/2020
Actual
Date of last participant enrolment
Anticipated
30/04/2020
Actual
Date of last data collection
Anticipated
30/10/2020
Actual
Sample size
Target
23
Accrual to date
Final
Recruitment outside Australia
Country [1] 21333 0
Spain
State/province [1] 21333 0
Sevilla

Funding & Sponsors
Funding source category [1] 302174 0
University
Name [1] 302174 0
University of Sevilla
Country [1] 302174 0
Spain
Primary sponsor type
University
Name
University of Sevilla
Address
Avicena Street (no number)
Sevilla
41009
Spain
Country
Spain
Secondary sponsor category [1] 302015 0
None
Name [1] 302015 0
Address [1] 302015 0
Country [1] 302015 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302856 0
Ethical Commitee of Biomedical Research of the Junta de Andalucia (Andalusian Regional Goverment, Spain)
Ethics committee address [1] 302856 0
Virgen Macarena University Hospital
Avenue Dr. Fedriani, 3
Research Unit
2nd Floor
41009 Sevilla (Spain)
Ethics committee country [1] 302856 0
Spain
Date submitted for ethics approval [1] 302856 0
15/01/2019
Approval date [1] 302856 0
26/02/2019
Ethics approval number [1] 302856 0
1861-N-17

Summary
Brief summary
The phenol-alcohol procedure its the gold standard, but it has a long time of recovery. The aim of this study is to show the reduction of the phenolization time to 30 seconds reduces the healing time without affecting the effectiveness of the procedure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91622 0
Mr Juan Manuel Muriel Sánchez
Address 91622 0
Departament of Podiatry.
Faculty of nursing, physiotherapy and podiatry.
University of Sevilla.
Avicena Street, no number
41009- Sevilla-Spain
Country 91622 0
Spain
Phone 91622 0
+34 655 45 73 93
Fax 91622 0
Email 91622 0
murielsanchezjm@gmail.com
Contact person for public queries
Name 91623 0
Manuel Coheña Jiménez
Address 91623 0
Departament of Podiatry.
Faculty of nursing, physiotherapy and podiatry.
University of Sevilla.
Avicena Street, no number
41009- Sevilla-Spain
Country 91623 0
Spain
Phone 91623 0
+34 954 55 48 60
Fax 91623 0
Email 91623 0
mcohena@us.es
Contact person for scientific queries
Name 91624 0
Pedro Montaño Jiménez
Address 91624 0
Departament of Podiatry.
Faculty of nursing, physiotherapy and podiatry.
University of Sevilla.
Avicena Street, no number
41009- Sevilla-Spain
Country 91624 0
Spain
Phone 91624 0
+34 954 55 48 60
Fax 91624 0
Email 91624 0
pmj@us.es

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only.
When will data be available (start and end dates)?
Immediately following publication and no end date determined.
Available to whom?
Only researchers who provide a methodologically sound proposal.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Access subject to approvals by Principal Investigator. (mcohena@us.es)


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
EmbaseEffect of phenol application time in the treatment of onychocryptosis: A randomized double-blind clinical trial.2021https://dx.doi.org/10.3390/ijerph181910478
N.B. These documents automatically identified may not have been verified by the study sponsor.