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Trial registered on ANZCTR


Registration number
ACTRN12619000399190
Ethics application status
Approved
Date submitted
5/03/2019
Date registered
12/03/2019
Date last updated
12/03/2019
Date data sharing statement initially provided
12/03/2019
Date results information initially provided
12/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of healing time and recurrence between phenol-alcohol procedure and aesthetic reconstruction procedure in patients with onychocryptosis.
Scientific title
Comparison of healing time and recurrence between phenol- alcohol procedure and aesthetic reconstruction procedure in patients with onychocryptosis.
Secondary ID [1] 297443 0
Nil Known
Universal Trial Number (UTN)
U1111-1229-3423
Trial acronym
ARPCT
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Onychocryptosis
311810 0
Condition category
Condition code
Surgery 310416 310416 0 0
Other surgery
Skin 310505 310505 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The same clinic (Dr. Pedro Montaño Jiménez) carried out all the surgical procedures of the hallux. The surgical procedure the authors proposed consisted in the partial ablation of the nail associated with a Aesthetic Reconstrucion of the nail fold. First, a digital blocking of the hallux using 2% of Mepivacaine, 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. The first cut was with an English-type cutter and afterward with a nº 15 scalpel. Next, the fragments of the nail plate were extracted with a Martini curette. A wedge excision of the soft tissue, including the nail matrix and the bed of the portion of tissue affected, was done, drying out the edges of the hypertrophic folds were this necessary. To check the intraoperative result of the excision a coaptation of the folds of the nail was carried out and subsequently a careful curettage of the matrix zone and the sub-nail bed was done using a Martini curette. After scrubbing with pressurized physiological serum, we reconstructed the nail folds with the help of approximation strips. The surgical wound was covered with non-stick absorbent sterile polypropylene impregnated with antiseptic and a partial bandage of the hallux was put in place. The hemostasis was removed, the blood test was checked, and a definitive compressive bandage was placed on the hallux.
Intervention code [1] 313830 0
Treatment: Surgery
Comparator / control treatment
For the Phenol-alcohol procedure, after removing the portion of the nail plate, a swab with a cotton ball soaked in 100% phenol was applied for 1 minute 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 and after with non-stick absorbent sterile polypropylene. Gauze was placed around the hallux and covered with a sterile compressive bandage. This treatment was done in the group randomly assigned to the procedure for comparison between groups.
Control group
Active

Outcomes
Primary outcome [1] 319318 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.
Timepoint [1] 319318 0
Period of time between the surgical action and the solving of the draining and/or inflammatory changes.
Primary outcome [2] 319319 0
Recurrence. A relapse of clinical reappearance.
Timepoint [2] 319319 0
Follow-up between 6-12 months. Twice per week the first week, once a week until the first month and once a month the rest of the follow-up.
Secondary outcome [1] 367730 0
Pain. 100mm visual analogue scale.
Timepoint [1] 367730 0
24, 48 and 72 hours after intervention.
Secondary outcome [2] 367731 0
Infection. Presence of infection was considered when there was pain and clinical drainage, or pus secretion with erythema was noted.
Timepoint [2] 367731 0
72 hours after intervention.
Secondary outcome [3] 367732 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] 367732 0
72 hours after intervention.

Eligibility
Key inclusion criteria
To have 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
Gender
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 treatment of the two groups was intraoperatively random 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
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 risk a = 0.05 and a risk ß = 0.2 in a bilateral contrast, 18 nail folds per group were required to detect a difference = 8 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 p<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21326 0
Spain
State/province [1] 21326 0
Sevilla

Funding & Sponsors
Funding source category [1] 302015 0
University
Name [1] 302015 0
University of Sevilla.
Address [1] 302015 0
Avicena Street (no number)
Sevilla
41009
Spain
Country [1] 302015 0
Spain
Primary sponsor type
University
Name
University of Sevilla.
Address
Avicena Street (no number)
Sevilla
41009
Spain
Country
Spain
Secondary sponsor category [1] 301801 0
None
Name [1] 301801 0
Address [1] 301801 0
Country [1] 301801 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302692 0
Ethical Committee of Biomedical Research of the Junta de Andalucía (Andalusian Regional Government, Spain)
Ethics committee address [1] 302692 0
Virgen Macarena University Hospital
Avenue Dr. Fedriani, 3
Research unit
2nd Floor
41009 Sevilla (Spain)
Ethics committee country [1] 302692 0
Spain
Date submitted for ethics approval [1] 302692 0
28/12/2017
Approval date [1] 302692 0
20/06/2018
Ethics approval number [1] 302692 0
1861-N-17

Summary
Brief summary
There exist various chemical procedures, such as: the gold standard procedure of Phenol-alcohol and its modifications.. Some procedures do not use chemical agents and reduce the recovery time.
This is why this study was designed to compare the effectiveness and the healing time between the Phenol-alcohol procedure and that proposed Aesthetic Reconstruction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91074 0
Mr Juan Manuel Muriel Sánchez
Address 91074 0
Departament of Podiatry.
Faculty of nursing, physiotherapy and podiatry.
University of sevilla.
c/Avicena s/n
41009- Sevilla- Spain
Country 91074 0
Spain
Phone 91074 0
+34 655 45 73 93
Fax 91074 0
Email 91074 0
murielsanchezjm@gmail.com
Contact person for public queries
Name 91075 0
Dr Manuel Coheña Jiménez
Address 91075 0
Departament of Podiatry.
Faculty of nursing, physiotherapy and podiatry.
University of sevilla.
c/Avicena s/n
41009- Sevilla- Spain
Country 91075 0
Spain
Phone 91075 0
+34954554860
Fax 91075 0
Email 91075 0
mcohena@us.es
Contact person for scientific queries
Name 91076 0
Dr Pedro Montaño Jiménez
Address 91076 0
Departament of Podiatry.
Faculty of nursing, physiotherapy and podiatry.
University of sevilla.
c/Avicena s/n
41009- Sevilla- Spain
Country 91076 0
Spain
Phone 91076 0
+34954554860
Fax 91076 0
Email 91076 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.
What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – plain English summary
In onychocryptosis surgery incisional and non-incisional matricectomy is indicated according to the stage. The Phenol procedure is the gold standard and a wedge resection is indicated for more advanced stages. Aesthetic Reconstrucion procedure having the advantage of the incisional procedure without eponychium incisions and an effectiveness similar to the Phenol-alcohol procedure.
The aim is compare the recurrence and the healing time between the Phenol-alcohol procedure and the Aesthetic Reconstrucion procedure.
A Comparative, prospective, randomized and one-blinded study. 34 patients (56 feet) with 112 onychocryptosis were randomized in two groups. 36 were treated with Phenol-alcohol and 76 with Aesthetic Reconstrucion procedure.
The Aesthetic Reconstrucion procedure presents a shorter healing time with a similar recurrence rate. Post-operatory bleeding, pain after 24, 48 and 72 hours and the infection rate did not show significant differences between the two procedures.