Nails, IngrownNAILTESTNCT02067897
Nonrandomized Assessment of Ingrown ToenaiLs Treated by Excision of Skinfold Rather Than Toenail
An observational study of Nails, Ingrown, run by Michael Livingston at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Nails, Ingrown
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population include children and adolescents aged 10 to 18 years with one or more ingrown toenails. They may have undergone previous surgical and/or non-surgical treatment for this condition.
Who may be able to join
- 10 to 18 years old
- Undergoing Vandenbos procedure for one or more ingrown toenails
- Willing to complete assessments
Who cannot join
- Inability to understand English
- Severe medical co-morbidities
Trial locations and contacts
1 site in 1 country.
Canada1 site
Children's Hospital of Western Ontario, London Health Sciences Centre
London, Ontario, N6A 5W9
About this study
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
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.
Read the 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.
- Conditions
- Nails, Ingrown
- Keywords
- Nails, Ingrown, Children, Ambulatory Surgical Procedures
- Medical subject headings
- Nails, Ingrown
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Clinical signs of recurrence will be assessed 1 month, 2 months, and 6 months after surgery.
Measured: Up to 6 months after surgery
Secondary outcomes (3)
Pain, functional status, and quality of life
Pain, functional status, and quality of life will be measured with the 5-item EuroQol-5D-5L.
Measured: Baseline, 1 month, 2 months, 6 months after surgery
Patient satisfaction
Patient satisfaction with the Vandenbos procedure will be measured with the 8-item Surgical Satisfaction Questionnaire (SSQ).
Measured: 6 months after surgery
Recovery time
Recovery time will be calculated in days off before returning to work, school, and normal footwear.
Measured: 1 month, 2 months, 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Nails, IngrownStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Livingston
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Sponsor-investigator, Michael Livingston, Western University, Canada
- Investigators
- Sarah A Jones, MD, PhD, FRCSC, Principal investigator, Division of Pediatric Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067897
- Sponsor's protocol ID
- 104906
- Acronym
- NAILTEST
- Status last verified
- Nov 2014
- First submitted
- 12 Feb 2014
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18485969Heidelbaugh JJ, Lee H. Management of the ingrown toenail. Am Fam Physician. 2009 Feb 15;79(4):303-8.
PubMed 19235497Eekhof 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.
PubMed 22513901Vandenbos 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.
PubMed 20646404Haricharan 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.
PubMed 22974574Antrum 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.
PubMed 6693479Persichetti 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.
PubMed 15167000Mitchell 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.
PubMed 21073822
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02067897
- Acronym / sponsor ID
- NAILTEST / 104906
- Conditions
- Nails, Ingrown
- Keywords
- Nails, Ingrown, Children, Ambulatory Surgical Procedures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Michael LivingstonUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Apr 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 20 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population include children and adolescents aged 10 to 18 years with one or more ingrown toenails. They may have undergone previous surgical and/or non-surgical treatment for this condition.
Key inclusion criteria (3 listed)
- 10 to 18 years old
- Undergoing Vandenbos procedure for one or more ingrown toenails
- Willing to complete assessments
Key exclusion criteria (2 listed)
- Inability to understand English
- Severe medical co-morbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence
Time frame: Up to 6 months after surgery
Clinical signs of recurrence will be assessed 1 month, 2 months, and 6 months after surgery.
3 secondary outcomes
Pain, functional status, and quality of life
Time frame: Baseline, 1 month, 2 months, 6 months after surgery
Patient satisfaction
Time frame: 6 months after surgery
Recovery time
Time frame: 1 month, 2 months, 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
- Background: PubMed 18485969Yang 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.
- Background: PubMed 19235497Heidelbaugh JJ, Lee H. Management of the ingrown toenail. Am Fam Physician. 2009 Feb 15;79(4):303-8.
- Background: PubMed 22513901Eekhof 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.
- BackgroundVandenbos KQ, Bowers WF. Ingrown toenail: a result of weight bearing on soft tissue. U S Arm Forces Med J 1959;10:1168-73.
- Background: PubMed 20646404Chapeskie 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.
- Background: PubMed 22974574Haricharan 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.
- Background: PubMed 6693479Antrum 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.
- Background: PubMed 15167000Persichetti 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.
- Background: PubMed 21073822Mitchell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah A Jones, MD, PhD, FRCSC principal investigator
Division of Pediatric Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nails, Ingrown, run by Michael Livingston at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: Up to 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02067897, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2014.