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Hyaluronic Acid in Postoperative Cures in the Phenol/Alcohol Technique (EHAPAT)

Primary Purpose

Nails, Ingrown, Hyaluronic Acid

Status
Completed
Phase
Early Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Hialucic
Betadine gel
Sponsored by
University of Malaga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nails, Ingrown focused on measuring matriceptomies, wound, nail

Eligibility Criteria

14 Years - 40 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Eva Lopezosa Reca

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Physiological cures using pure hyaluronic acid (Hialucic®)

Control group using traditional cure (Betadine Gel).

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Time elapsed until the primary healing and total healing of the wound
We measure the days that the patients wait to see the wound perfectly between 0 days until 300 days

Secondary Outcome Measures

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
Visual analog scale pain between 0 to 100 mm
Presence of complications such as infection
Noted at the end of treatment or dressing change

Full Information

First Posted
March 13, 2021
Last Updated
January 16, 2023
Sponsor
University of Malaga
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1. Study Identification

Unique Protocol Identification Number
NCT04812457
Brief Title
Hyaluronic Acid in Postoperative Cures in the Phenol/Alcohol Technique
Acronym
EHAPAT
Official Title
Effectiveness of Hyaluronic Acid in Postoperative Cures in Partial Matriceptomes With the Phenol/Alcohol Technique. Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 6, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaga

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the efficacy of a postoperative treatment protocol with hyaluronic acid-based ointment compared to the standard protocol (betadine gel) in partial chemical matricectomies with phenol alcohol technique. This will allow to see if the use of hyaluronic acid could help to reduce the healing time and total recovery of this surgical technique
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nails, Ingrown, Hyaluronic Acid
Keywords
matriceptomies, wound, nail

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physiological cures using pure hyaluronic acid (Hialucic®)
Arm Type
Experimental
Arm Description
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
Arm Title
Control group using traditional cure (Betadine Gel).
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Hialucic
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Betadine gel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time elapsed until the primary healing and total healing of the wound
Description
We measure the days that the patients wait to see the wound perfectly between 0 days until 300 days
Time Frame
from the intervention until 15 weeks late
Secondary Outcome Measure Information:
Title
Presence of exudate
Description
(Very Abundant / Abundant / Slight / Absent).
Time Frame
from the intervention until 15 weeks late
Title
Reduction of inflammation
Description
measured in mm with flexible tape around the eponychium
Time Frame
from the intervention until 15 weeks late
Title
cost
Description
average costs for all materials used per patient in €
Time Frame
from the intervention until 15 weeks late
Title
Visual analog scale pain
Description
Visual analog scale pain between 0 to 100 mm
Time Frame
from the intervention until 15 weeks late
Title
Presence of complications such as infection
Description
Noted at the end of treatment or dressing change
Time Frame
from the intervention until 15 weeks late

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel Gijon-Nogueron, PhD
Organizational Affiliation
University of Malaga
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eva Lopezosa Reca
City
Málaga
ZIP/Postal Code
29720
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15204151
Citation
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.
Results Reference
background
PubMed Identifier
20573174
Citation
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.
Results Reference
background
PubMed Identifier
9298440
Citation
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.
Results Reference
background
PubMed Identifier
23149533
Citation
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.
Results Reference
background

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Hyaluronic Acid in Postoperative Cures in the Phenol/Alcohol Technique

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