Hyaluronic Acid in Postoperative Cures in the Phenol/Alcohol Technique

NCT04812457 | Completed Early Phase 1 DMC

• 1 other identifier: UMalagaUEX2021
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Nails, Ingrown; Hyaluronic Acid

Keywords

matriceptomies; wound; nail

Outcome Measures

Primary Outcomes (1)

• 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

  from the intervention until 15 weeks late

Secondary Outcomes (5)

• Presence of exudate

  from the intervention until 15 weeks late

• Reduction of inflammation

  from the intervention until 15 weeks late

• cost

  from the intervention until 15 weeks late

• Visual analog scale pain

  from the intervention until 15 weeks late

• Presence of complications such as infection

  from the intervention until 15 weeks late

Study Arms (2)

Physiological cures using pure hyaluronic acid (Hialucic®)

EXPERIMENTAL

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

Drug: Hialucic

Control group using traditional cure (Betadine Gel).

ACTIVE COMPARATOR

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.

Drug: Betadine gel

Interventions

Hialucic DRUG

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.

Physiological cures using pure hyaluronic acid (Hialucic®)

Betadine gel DRUG

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.

Control group using traditional cure (Betadine Gel).

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Onychocyptosis with significant involvement of the hypertrophic labrum
• Severe paronychias
• Allergy to any of the substances used in the intervention or in the cures.

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

Eva Lopezosa Reca

Málaga, 29720, Spain

Location

Related Publications (4)

• 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.

  PMID: 15204151 BACKGROUND

• 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.

  PMID: 20573174 BACKGROUND

• 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.

  PMID: 9298440 BACKGROUND

• 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.

  PMID: 23149533 BACKGROUND

MeSH Terms

Conditions

Nails, Ingrown; Wounds and Injuries

Condition Hierarchy (Ancestors)

Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gabriel Gijon-Nogueron, PhD

  University of Malaga

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 13, 2021
• First Posted: March 23, 2021
• Study Start: March 6, 2021
• Primary Completion: February 1, 2022
• Study Completion: June 1, 2022
• Last Updated: January 19, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)