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CTRI Number  CTRI/2025/09/094969 [Registered on: 17/09/2025] Trial Registered Prospectively
Last Modified On: 16/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   “Comparing Two Simple Nail Support Methods for Early Ingrown Toenails: Cotton Nail Cast vs. Gutter Splint” 
Scientific Title of Study   Efficacy of Cotton Nail Cast Versus Enhanced Gutter Splint in Early Stage Great Toe Onychocryptosis (Stage 1 and 2a):A Randomised Control Trial at a Tertiary care Centre in Mandya. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shivu N 
Designation  Post graduate, Department of Dermatology, MIMS , Mandya 
Affiliation  Mandya institute of medical sciences, Mandya 
Address  OPD No-13 , 2nd floor Department of dermatology Mandya institute of medical sciences, Mandya-571403

Mandya
KARNATAKA
571403
India 
Phone  7760640806  
Fax    
Email  shivunagaraj111@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shashikumar B M 
Designation  Associate professor and Head of the department, Department of Dermatology, MIMS ,Mandya 
Affiliation  Mandya institute of medical sciences, Mandya 
Address  OPD No-13 , 2nd floor Department of dermatology Mandya institute of medical sciences, Mandya-571403

Mandya
KARNATAKA
571403
India 
Phone  9886197902  
Fax    
Email  shashikumarbm@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shashikumar B M 
Designation  Associate professor and Head of the department, Department of Dermatology, MIMS ,Mandya 
Affiliation  Mandya institute of medical sciences, Mandya 
Address  OPD No-13 , 2nd floor Department of dermatology Mandya institute of medical sciences, Mandya-571403

Mandya
KARNATAKA
571403
India 
Phone  9886197902  
Fax    
Email  shashikumarbm@gmail.com  
 
Source of Monetary or Material Support  
OPD No-13 , 1st floor, Department of dermatology, Mandya institute of medical sciences, India, Karnataka, Mandya - 571403. 
 
Primary Sponsor  
Name  Shivu N 
Address  OPD No-13 , 1st floor, Department of dermatology, Mandya institute of medical sciences, India, Karnataka, Mandya - 571403. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shivu N  Mandya institute of medical sciences, Mandya  OPD No 13 , 1st floor Department of dermatology.
Mandya
KARNATAKA 		 7760640806

shivunagaraj111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Ethics Committee, MIMS , Mandya  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L600||Ingrowing nail,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cotton nail cast  •Name: Cotton Nail Cast •Type: Conservative non-surgical technique •Description: Placement of a small rolled piece of sterile cotton beneath the ingrown edge of the great toenail to elevate the nail plate, fixing it with cyanoacrylate adhesive , relieve pressure on periungual tissue, and guide normal nail growth. •Dosage/Duration: Applied in each outpatient visit and replaced as required until resolution of symptoms or end of follow-up period. 
Comparator Agent  enhanced gutter splint technique   •Name: Enhanced Gutter Splint Technique •Type: Conservative non-surgical technique •Description: Insertion of a trimmed sterile intravenous infusion tube or pediatric NG tube segment (gutter splint) along the ingrown nail edge after local anesthesia, fixed with adhesive to protect periungual skin and guide proper nail growth. •Dosage/Duration: Applied once and retained in place until spontaneous extrusion or until resolution of symptoms or upto 4 to 6 weeks, with follow-up as per protocol.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with symptomatic ingrown toenail (Stage I or IIa ) aged more than 18 years of age , both sexes attending the outpatient department of dermatology and willing to give written informed consent for the study.
 
 
ExclusionCriteria 
Details  Peripheral vascular disease.
Active local infection or cellulitis.
Immunocompromised status (e.g., HIV, Transplant recipients , Uncontrolled diabetes mellitus).
Allergy to cyanoacrylate glue.
Local deformity of the digit (e.g, Hallux varus/valgus).
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of Cotton Nail Cast and Enhanced Gutter Splint Technique in Stage 1 & 2a Disease onychocryptosis patients attending the outpatient department of dermatology, MIMS , Mandya.  Baseline (Day 0) – Before intervention .
Day 3, Day 7, 1 Month, 3 Months, and 6 Months.
Symptom evaluation: pain, difficulty walking, shoe-wear limitation
Clinical signs: erythema, swelling, granulation tissue, discharge
Photographs: taken at baseline, and at 1, 3, and 6 months
Pain scores: using Visual Analog Scale (VAS)
Assessment of complications: recurrence, nail dystrophy, infection, abscess, scarring, or spike formation 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate and compare patient satisfaction, postoperative pain, healing time, and complications between the two treatment modalities.
 		 Baseline (Day 0) – Before intervention .
Day 3, Day 7, 1 Month, 3 Months, and 6 Months.
Symptom evaluation: pain, difficulty walking, shoe-wear limitation
Clinical signs: erythema, swelling, granulation tissue, discharge
Photographs: taken at baseline, and at 1, 3, and 6 months
Pain scores: using Visual Analog Scale (VAS)
Assessment of complications: recurrence, nail dystrophy, infection, abscess, scarring, or spike formation
 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   01/10/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This prospective randomised comparative study evaluates the effectiveness of cotton nail cast and enhanced gutter splint techniques in managing early-stage great toe onychocryptosis (Stage 1 and 2a) at a tertiary care centre in Mandya. Patients meeting inclusion criteria will be randomised into two equal groups to receive either cotton nail cast or enhanced gutter splint application. Both are conservative, minimally invasive methods designed to relieve pain, reduce periungual inflammation, and correct nail plate embedding without surgery.

Participants will be assessed at baseline, Day 3, Day 7, 1 Month, 3 Months, and 6 Months.  Primary objective is To evaluate and compare efficacy, patient satisfaction, postoperative pain, healing time, and complications between the two treatment modalities.The study aims to provide comparative evidence on two low-cost, office-based techniques, helping clinicians choose the most effective and patient-friendly method for early-stage ingrown toenail management, potentially reducing the need for surgical interventions.


 
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