- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04812457
Hyaluronic Acid in Postoperative Cures in the Phenol/Alcohol Technique (EHAPAT)
Effectiveness of Hyaluronic Acid in Postoperative Cures in Partial Matriceptomes With the Phenol/Alcohol Technique. Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A randomized controlled multicenter study will be conducted. Subject (n=60) will be adolescent and healthy adults, between 14 and 40 years old, who require and demand surgical treatment of onychocryptosis or stage I or IIa ingrown nail in the participating centers.
After acceptance to participate in the study, they will be operated on in a standardized protocol with phenol-alcohol technique. Then they will be randomly assigned into 2 groups, to perform different treatment protocols. The experimental group will receive physiological cures using pure hyaluronic acid (Hialucic®) after the onychocryptosis surgery, while the control group will receive traditional cure (Betadine Gel). The periodicity of cures in both groups will be the same, 48 hours, 6 days, 12 days 16 days and 20 days. For the design of the study, the bases on randomized clinical studies described in CONSORT will be followed.
The outcome measurement will be the presence of exudate in each of the cures (carried out at the same post-surgical times), presence or absence of granulation tissue, reduction of inflammation (measured with the circumference of the finger in the eponychium area), cost average treatment protocol, time elapsed until primary healing (when the wound stops staining the bandage) and final surgical discharge (finger without wound or inflammation), referred pain in the finger during the healing period and presence of complications, such like persistent inflammation, infection, etc.
PARTICIPANTS
Participants will be recruited through the Podiatric Clinic of the University of Extremadura and Lopezosa y Gijon Nogueron clinics in Malaga and Granada
SAMPLE´S SIZE CALCULATION
The confidence level was established at 95% and the statistical power at 90%. We need a minimum precision value of 3 days (time between cures). The squared variance (S2) is 16, since in a previous pilot study the variance between groups of cures was 4 days
The inclusion criteria were as follows:
- Patients aged between 14 and 40 years old
- Patients with stage I, II, or III onychocryptosis (Kline classification) or Mozena stage I or IIa [7]
- Patients with onychocryptosis unilateral or bilateral.
- Healthy patients without previous systematic pathologies (diabetes, coagulation or immunological disorders) who require and demand surgical treatment of their pathology in the participating centers and willing to participate in the study.
Participants were excluded if any of the following were present:
- Onychocyptosis with significant involvement of the hypertrophic labrum
- Patients with hyperhidrosis
- Severe paronychias
- Allergy to any of the substances used in the intervention or in the cures.
2.3 RANDOMIZATION Participants will be divided into two groups: a) experimental or intervention group (hyaluronic acid cures) and b) control group (Betadine Gel cures) by random assignment of sealed envelopes, which will be previously sealed in sequential order. Both the patient and the researcher will be blinded to hide the group to which each patient belongs.
2.4 INTERVENTION
For the intervention of unilateral onychocryptosis, the partial matricectomy technique with phenol / alcohol will be carried out. After removal of the affected spicule, basic manual curettage will be performed with a Wolkmann or Martini spoon. Once the matrix has been mechanically removed, the phenol will be applied. Phenol 88% in sterile capsules will be used in the affected canal using a cotton swab for two applications of 30 seconds. Between these two applications, alcohol will be used to dissolve the phenol present in the nail bed. After the last application of phenol, the area will be washed again with alcohol.
After the intervention, hyaluronic acid will be applied in the operated canal. A non-stick dressing impregnated with Betadine will be placed and a semi-compression bandage will be applied.
A professional not present at the intervention (researcher 2) will proceed to carry out the postoperative cures 48 hours after the intervention. The bandage will be removed, the area will be washed with physiological saline and the drug will be applied according to the group to which it belongs. In the intervention group, an ointment with hyaluronic acid (hyalucic ®) will be used together with a non-stick dressing and a semi-compression bandage to prevent bleeding. In the control group, Povidone Iodine Gel (Betadine Gel®) will be applied following the same procedure.
Successive cures will be carried out every 2 days by the healthcare professional, where both groups will be washed with saline solution and a new dose of ointment will be applied as appropriate in each group. hyaluronic acid for cures a maximum of 4 times, to avoid maceration of the wound. the rest of the cures will be with Betadine. Primary healing will be taken as the first variable of surgical results and the definitive discharge time, which will be determined by researcher 2 (who was responsible for the cures) and confirmed by a third evaluator, who will verify the results.
2.5 OUTCOME MEASURE
The demographic characteristics of the participants will be age, sex, and onychocryptosis classification according to Kline or Mozena.
The variables to be used are:
- Dressing application time (time recorded in min).
- Presence of exudate (Very Abundant / Abundant / Slight / Absent).
- Reduction of inflammation, measured in mm with flexible tape around the eponychium.
- Cost (average costs for all materials used per patient in €),
- Visual analog scale pain (VAS)
- Presence of complications such as infection (noted at the end of treatment or dressing change).
- Time elapsed until the primary healing and total healing of the wound (days).
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Gabriel Gijon Nogueron, PhD
- Phone Number: +34626449254
- Email: gagijon@uma.es
Study Locations
-
-
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Málaga, Spain, 29720
- Eva Lopezosa Reca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients aged between 14 and 40 years old
- Patients with stage I, II, or III onychocryptosis (Kline classification) or Mozena stage I or IIa
- Patients with onychocryptosis unilateral or bilateral.
- Healthy patients without previous systematic pathologies (diabetes, coagulation or immunological disorders) who require and demand surgical treatment of their pathology in the participating centers and willing to participate in the study.
Exclusion Criteria:
- Onychocyptosis with significant involvement of the hypertrophic labrum
- Severe paronychias
- Allergy to any of the substances used in the intervention or in the cures.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Physiological cures using pure hyaluronic acid (Hialucic®)
After the intervention of unilateral onychocryptosis, the partial matricectomy technique with phenol / alcohol,next to an ointment with hyaluronic acid (hyalucic ®) will be used together with a non-stick dressing and a semi-compression bandage to prevent bleeding
|
A professional not present at the intervention (researcher 2) will proceed to carry out the postoperative cures 48 hours after the intervention.
The bandage will be removed, the area will be washed with physiological saline and the drug will be applied according to the group to which it belongs.
In the intervention group, an ointment with hyaluronic acid (hyalucic ®) will be used together with a non-stick dressing and a semi-compression bandage to prevent bleeding.
|
Active Comparator: Control group using traditional cure (Betadine Gel).
After the intervention of unilateral onychocryptosis, the partial matricectomy technique with phenol / alcohol,next to Povidone Iodine Gel (Betadine Gel®) will be applied following the same procedure.
|
A professional not present at the intervention (researcher 2) will proceed to carry out the postoperative cures 48 hours after the intervention.
The bandage will be removed, the area will be washed with physiological saline and the drug will be applied according to the group to which it belongs.
In the control group, Betadine Gel will be used together with a non-stick dressing and a semi-compression bandage to prevent bleeding.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time elapsed until the primary healing and total healing of the wound
Time Frame: from the intervention until 15 weeks late
|
We measure the days that the patients wait to see the wound perfectly between 0 days until 300 days
|
from the intervention until 15 weeks late
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of exudate
Time Frame: from the intervention until 15 weeks late
|
(Very Abundant / Abundant / Slight / Absent).
|
from the intervention until 15 weeks late
|
Reduction of inflammation
Time Frame: from the intervention until 15 weeks late
|
measured in mm with flexible tape around the eponychium
|
from the intervention until 15 weeks late
|
cost
Time Frame: from the intervention until 15 weeks late
|
average costs for all materials used per patient in €
|
from the intervention until 15 weeks late
|
Visual analog scale pain
Time Frame: from the intervention until 15 weeks late
|
Visual analog scale pain between 0 to 100 mm
|
from the intervention until 15 weeks late
|
Presence of complications such as infection
Time Frame: from the intervention until 15 weeks late
|
Noted at the end of treatment or dressing change
|
from the intervention until 15 weeks late
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gabriel Gijon-Nogueron, PhD, University of Malaga
Publications and helpful links
General Publications
- Andreassi A, Grimaldi L, D'Aniello C, Pianigiani E, Bilenchi R. Segmental phenolization for the treatment of ingrowing toenails: a review of 6 years experience. J Dermatolog Treat. 2004 Jun;15(3):179-81. doi: 10.1080/09546630410026860.
- Hassel JC, Hassel AJ, Loser C. Phenol chemical matricectomy is less painful, with shorter recovery times but higher recurrence rates, than surgical matricectomy: a patient's view. Dermatol Surg. 2010 Aug;36(8):1294-9. doi: 10.1111/j.1524-4725.2010.01625.x. Epub 2010 Jun 22.
- Giacalone VF. Phenol matricectomy in patients with diabetes. J Foot Ankle Surg. 1997 Jul-Aug;36(4):264-7; discussion 328. doi: 10.1016/s1067-2516(97)80070-1.
- Karaca N, Dereli T. Treatment of ingrown toenail with proximolateral matrix partial excision and matrix phenolization. Ann Fam Med. 2012 Nov-Dec;10(6):556-9. doi: 10.1370/afm.1406. Erratum In: Ann Fam Med. 2013 Jan-Feb;11(1):4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UMalagaUEX2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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