Nonrandomized Assessment of Ingrown ToenaiLs Treated by Excision of Skinfold Rather Than Toenail
NCT ID: NCT02067897
Last Updated: 2014-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
50 participants
OBSERVATIONAL
2014-04-30
2016-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Vandenbos procedure (skinfold excision)
Participants in this cohort will undergo with Vandenbos procedure (skinfold excision) for one or more ingrown toenails. This surgery will be formed as an day procedure under general anesthetic.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Undergoing Vandenbos procedure for one or more ingrown toenails
* Willing to complete assessments
Exclusion Criteria
* Severe medical co-morbidities
10 Years
18 Years
ALL
No
Sponsors
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The Physicians' Services Incorporated Foundation
OTHER
Michael Livingston
OTHER
Responsible Party
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Michael Livingston
Resident, Division of General Surgery
Principal Investigators
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Sarah A Jones, MD, PhD, FRCSC
Role: PRINCIPAL_INVESTIGATOR
Division of Pediatric Surgery
Locations
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Children's Hospital of Western Ontario, London Health Sciences Centre
London, Ontario, Canada
Countries
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References
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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.
Heidelbaugh JJ, Lee H. Management of the ingrown toenail. Am Fam Physician. 2009 Feb 15;79(4):303-8.
Eekhof JA, Van Wijk B, Knuistingh Neven A, van der Wouden JC. Interventions for ingrowing toenails. Cochrane Database Syst Rev. 2012 Apr 18;2012(4):CD001541. doi: 10.1002/14651858.CD001541.pub3.
Vandenbos KQ, Bowers WF. Ingrown toenail: a result of weight bearing on soft tissue. U S Arm Forces Med J 1959;10:1168-73.
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.
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.
Antrum RM. Radical excision of the nailfold for ingrowing toenail. J Bone Joint Surg Br. 1984 Jan;66(1):63-5. doi: 10.1302/0301-620X.66B1.6693479.
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. doi: 10.1097/01.sap.0000095436.08812.67.
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.
Other Identifiers
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104906
Identifier Type: -
Identifier Source: org_study_id