None listed
Conditions
Brief summary
This study is a randomized controlled trial in patients with onychocryptosis in stage I and IIA on nails with pathological curvatures, which aims to determine and compare the effectiveness of the nail spicules cutting technique and the combination of the nail spicules cutting technique with the orthonyxia technique, as well as quantify the width change nail which is achieved with the orthonyxia technique. It was established as a hypothesis, that the treatment of onychocryptosis combining the orthonyxia technique with the nail spicules cutting technique, presents one lower rate of recurrence than the nail spicules cutting technique alone and that the use of the orthonyxia technique has the ability to significantly correct the pathological curvature of the nail plate.
Interventions
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 o
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.
Sponsors
University of Seville
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
8 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed