Nonrandomized Assessment of Ingrown ToenaiLs Treated by Excision of Skinfold Rather Than Toenail
- Conditions
- Nails, Ingrown
- Registration Number
- NCT02067897
- Lead Sponsor
- Michael Livingston
- Brief Summary
Ingrown toenails occur when the nail grows into the surrounding skin, resulting in pain and infection. The most common procedure to treat this problem is a wedge excision (removal of part of the toenail) and matricectomy (destruction of part of the nailbed with chemicals or surgical instruments). This study will evaluate the effectiveness of an alternative technique called the Vandenbos procedure (where the skin is removed and the toenail is left intact). This procedure is currently being used by some of the pediatric surgeons at our hospital and we want to evaluate our results up to 6 months after surgery. We believe that the true recurrence rate will be greater than 0% but that recovery time and morbidity will be acceptable to most patients.
- Detailed Description
Ingrown toenails are common among adolescents and young adults with the big toe being the most commonly affected. The exact incidence is unknown. An ingrown toenail occurs when the nail traumatizes the surrounding skin, resulting in swelling, infection, and the generation of granulation tissue. This cycle causes the nail to embed itself even further into the surrounding tissues, leading to additional swelling and infection.
Many treatments have been proposed for this condition. Non-surgical options include soaking, wearing loose shoes, antibiotics, and specialized braces. While these treatments often provide short-term symptomatic relief, many people with ingrown toenails eventually need surgery. The most common surgical treatment is a wedge excision (removal of the ingrown part of the nail). Most clinicians perform a partial matricectomy at the same time (destruction of part of the underlying nailbed with chemicals or surgical instruments). This prevents recurrence (where the toenail becomes ingrown again). The rate of recurrence with the wedge excision and matricectomy is reported to be 12-50%.
An alternative surgical technique is the Vandenbos procedure, where the skinfold is excised and allowed to heal by secondary intention over a period of approximately 6 weeks. This approach theoretically involves more pain, a higher risk of post-operative bleeding (because it is initially an open wound), and a longer recovery time. Proponents of this technique argue that these short-term morbidities are justified given the low rate of recurrence and excellent long-term results.
The original case series published by Vandenbos in 1959 found a recurrence rate of 0%. Two recent case series published by doctors from Ontario reported the same finding, but it was unclear how many patients in their series were lost to follow-up. Other studies have reported positive results but with a recurrence rate of 7-20%. Thus, the true effectiveness of this procedure remains unclear. Furthermore, there is no high quality evidence to support one technique over the other. Even a recent Cochrane review of 24 randomized controlled trials could not reach any definitive conclusions as to which procedure (among other surgical options) is the most effective. Previous trials show significant heterogeneity and none have assessed the Vandenbos procedure specifically. As a result, many clinicians continue to use the wedge excision and matricectomy.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- 10 to 18 years old
- Undergoing Vandenbos procedure for one or more ingrown toenails
- Willing to complete assessments
- Inability to understand English
- Severe medical co-morbidities
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Recurrence Up to 6 months after surgery Clinical signs of recurrence will be assessed 1 month, 2 months, and 6 months after surgery.
- Secondary Outcome Measures
Name Time Method Pain, functional status, and quality of life Baseline, 1 month, 2 months, 6 months after surgery Pain, functional status, and quality of life will be measured with the 5-item EuroQol-5D-5L.
Patient satisfaction 6 months after surgery Patient satisfaction with the Vandenbos procedure will be measured with the 8-item Surgical Satisfaction Questionnaire (SSQ).
Recovery time 1 month, 2 months, 6 months after surgery Recovery time will be calculated in days off before returning to work, school, and normal footwear.
Trial Locations
- Locations (1)
Children's Hospital of Western Ontario, London Health Sciences Centre
🇨🇦London, Ontario, Canada