Comparison of 88% phenol and 10% sodium hydroxide chemical matricectomy along with partial nail avulsion for the management of ingrowing toe nail
Trial Snapshot
- Phase
- Phase 4
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 1.Time to complete healing: This will be recorded in terms of the number of days taken to achieve healing of the operated area defined as discharge (Grade 0); no evidence of tissue destruction; no raw areas or erosions.
Study Overview
Brief Summary
SUMMARY
Ingrown toe nail is a common painful condition affecting the feet. In a large number of cases, surgical management in the form of partial nail avulsion is required to remove the lateral most ingrowing edge of the nail plate. However, a simple avulsion is associated with high chances of recurrence. Destruction of the lateral horns of the matrix should be an essential component of the management of ingrowing toenail. This may be achieved by surgical, or more commonly, a chemical destruction of the lateral part of nail matrix. Phenol (88% solution) is one of the commonest agents used successfully for decades. However, it causes excessive post operative drainage and prolonged recovery time because of the significant collateral damage to adjacent tissues. Alternate agents, which would cause lesser post-operative morbidity, have often been researched. Sodium hydroxide (10% solution) is an alternative which has been found to be safe and efficacious with less post operative drainage. However, at present it lacks significant scientific documentation except for a few studies16.
In the present study, we plan to assess patients with ingrown toe nail who require surgical management so as to compare the two agents in a blinded, randomized controlled fashion with respect to their efficacy, post operative recovery time and acceptability. Such an extensive comparison between the two agents would be useful for dermatologists/surgeons in successful management of ingrown toenail, with minimum morbidity to the patient.
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patients with a clinical diagnosis of ingrown toenail, who are symptomatic presenting to the dermatology clinic of GTB hospital, with ages between 18 to 60 years.
- •2.Patients willing to participate in the study according to the protocol.
Exclusion Criteria
- •1.Those with significant peripheral arterial disease or history of chronic smoking 2.Known allergy to the chemical agents being used 3.Conditions associated with delayed wound healing e.g. Diabetes Mellitus.
- •4.Pregnant or lactating women.
- •5.Patients not consenting for surgical intervention or for inclusion in the study protocol.
Outcomes
Primary Outcomes
1.Time to complete healing: This will be recorded in terms of the number of days taken to achieve healing of the operated area defined as discharge (Grade 0); no evidence of tissue destruction; no raw areas or erosions.
Time Frame: 1.Time to complete healing: This will be recorded in terms of the number of days taken to achieve healing of the operated area defined as discharge (Grade 0); no evidence of tissue destruction; no raw areas or erosions.
Secondary Outcomes
- 2.Cure: This will be defined as healing along with absence of pain (score 0). The number of patients cured within each group will be recorded.(Assessed at each visit as per protocol.)
- 3.Recurrence: All the patients will be followed up for a minimum period of one year. Any reappearance of pain, discharge, inflammation or swelling of the nail fold in a patient who had previously been cured will counted as a recurrence.(Assessed at each visit (as per protocol) upto a maximum of ONE YEAR)