Nonrandomized Assessment of Ingrown ToenaiLs Treated by Excision of Skinfold Rather Than Toenail

Nails, Ingrown Clinical Trial

— NAILTEST  

Official title:

Nonrandomized Assessment of Ingrown ToenaiLs Treated by Excision of Skinfold Rather Than Toenail (NAILTEST): a Study of the Vandenbos Procedure in Children and Adolescents

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02067897
• Other study ID #: 104906
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 12, 2014
• Last updated: November 11, 2014
• Start date: April 2014
• Est. completion date: April 2016

Study information

• Verified date: November 2014
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ministry of Health & Long Term Care, Ontario
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• 10 to 18 years old

• Undergoing Vandenbos procedure for one or more ingrown toenails

• Willing to complete assessments

Exclusion Criteria:

• Inability to understand English

• Severe medical co-morbidities

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Nails, Ingrown

Locations

Country	Name	City	State
Canada	Children's Hospital of Western Ontario, London Health Sciences Centre	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Michael Livingston	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (9)

Antrum RM. Radical excision of the nailfold for ingrowing toenail. J Bone Joint Surg Br. 1984 Jan;66(1):63-5. — View Citation

Chapeskie H, Kovac JR. Case Series: Soft-tissue nail-fold excision: a definitive treatment for ingrown toenails. Can J Surg. 2010 Aug;53(4):282-6. — View Citation

Eekhof JA, Van Wijk B, Knuistingh Neven A, van der Wouden JC. Interventions for ingrowing toenails. Cochrane Database Syst Rev. 2012 Apr 18;4:CD001541. doi: 10.1002/14651858.CD001541.pub3. Review. — View Citation

Haricharan RN, Masquijo J, Bettolli M. Nail-fold excision for the treatment of ingrown toenail in children. J Pediatr. 2013 Feb;162(2):398-402. doi: 10.1016/j.jpeds.2012.07.056. Epub 2012 Sep 10. — View Citation

Heidelbaugh JJ, Lee H. Management of the ingrown toenail. Am Fam Physician. 2009 Feb 15;79(4):303-8. Review. — View Citation

Mitchell S, Jackson CR, Wilson-Storey D. Surgical treatment of ingrown toenails in children: what is best practice? Ann R Coll Surg Engl. 2011 Mar;93(2):99-102. doi: 10.1308/003588411X12851639107674. Epub 2010 Nov 12. — View Citation

Persichetti P, Simone P, Li Vecchi G, Di Lella F, Cagli B, Marangi GF. Wedge excision of the nail fold in the treatment of ingrown toenail. Ann Plast Surg. 2004 Jun;52(6):617-20. — View Citation

Vandenbos KQ, Bowers WF. Ingrown toenail: a result of weight bearing on soft tissue. U S Arm Forces Med J 1959;10:1168-73.

Yang G, Yanchar NL, Lo AY, Jones SA. Treatment of ingrown toenails in the pediatric population. J Pediatr Surg. 2008 May;43(5):931-5. doi: 10.1016/j.jpedsurg.2007.12.042. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence	Clinical signs of recurrence will be assessed 1 month, 2 months, and 6 months after surgery.	Up to 6 months after surgery	No
Secondary	Pain, functional status, and quality of life	Pain, functional status, and quality of life will be measured with the 5-item EuroQol-5D-5L.	Baseline, 1 month, 2 months, 6 months after surgery	No
Secondary	Patient satisfaction	Patient satisfaction with the Vandenbos procedure will be measured with the 8-item Surgical Satisfaction Questionnaire (SSQ).	6 months after surgery	No
Secondary	Recovery time	Recovery time will be calculated in days off before returning to work, school, and normal footwear.	1 month, 2 months, 6 months after surgery	No