| CTRI Number |
CTRI/2013/11/004164 [Registered on: 22/11/2013] Trial Registered Retrospectively |
| Last Modified On: |
02/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
88% Phenol vs 10% NaOH in the treatment of Ingrown toe-nail |
|
Scientific Title of Study
|
Comparison of 88% phenol and 10% sodium hydroxide chemical matricectomy along with partial nail avulsion for the management of ingrowing toe nail |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chander Grover |
| Designation |
Assistant Professor, Dermatology |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
Department of Dermatology,
University College of Medical Sciences,
Dilshad Garden, Delhi-110095
Dilshad Garden, Delhi-110091
North East
DELHI
110091
India |
| Phone |
9818065653 |
| Fax |
|
| Email |
chandergroverkubba@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chander Grover |
| Designation |
Assistant Professor, Dermatology |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
420-B, Pocket 2, Mayur Vihar, Phase-1, Delhi
Dilshad Garden, Delhi-110091
DELHI
110091
India |
| Phone |
9818065653 |
| Fax |
|
| Email |
chandergroverkubba@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chander Grover |
| Designation |
Assistant Professor, Dermatology |
| Affiliation |
University College of Medical Sciences and GTB Hospital |
| Address |
420-B, Pocket 2, Mayur Vihar, Phase-1, Delhi
Dilshad Garden, Delhi-110091
DELHI
110091
India |
| Phone |
9818065653 |
| Fax |
|
| Email |
chandergroverkubba@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Research institution and hospital |
| Address |
University College of Medical Sciences and GTB Hospital, Delhi-110095 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chander Grover |
Department of Dermatology, GTB Hopsital and UCMS |
UCMS and GTB Hospital,
Dilshad Garden, Delhi-110095
North East
DELHI |
9818065653
chandergroverkubba@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee- Human Research (IEC-HR), University College of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L600||Ingrowing nail, Patients with Ingrown toe nails, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Partial nail avulsion and Lateral horn chemical matricectomy with Sodium hydroxide solution (10%) |
Agent: Sodium hydroxide solution (10% solution)
Mode of administration: Topical application (SINGLE EXPOSURE) over the exposed lateral matrix. Applied with vigorous rubbing of 10% solution with a cotton tipped applicator over the exposed lateral horn.
Total duration: One minute |
| Comparator Agent |
Partial nail avulsion with Lateral horn Chemical Matricectomy with Phenol (88% solution) |
Agent: Phenol (88% solution)
Mode of administration: Topical application (SINGLE EXPOSURE) over the exposed lateral matrix. Applied with vigorous rubbing of 88% solution with a cotton tipped applicator over the exposed lateral horn.
Total duration: One minute |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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
|
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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. |
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 Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
23/03/2012 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
Indian J Dermatol Venereol Leprol. 2015 Sep-Oct;81(5):472-7. doi: 10.4103/0378-6323.163787.
Controlled trial comparing the efficacy of 88% phenol versus 10% sodium hydroxide for chemical matricectomy in the management of ingrown toenail.
Grover C1, Khurana A, Bhattacharya SN, Sharma A.
Author information
1
Department of Dermatology and STD, University College of Medical Sciences and Guru Teg Bahadur Hospital, Dilshad Garden, Delhi, India. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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. |