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.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
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.
时间窗: 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
次要结局
- To evaluate and compare patient satisfaction, postoperative pain, healing time, and complications between the two treatment modalities.
研究者
Dr Shivu N
Mandya institute of medical sciences, Mandya