Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202202706271436 Date of Approval: 07/02/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Gutter Splint method vs Chemical Matricectomy using phenol 88% in the treatment of ingrown toenail
Official scientific title Comparison of Chemical Matricectomy with Gutter Splint method vs Chemical Matricectomy using phenol 88% for Ingrown Toenails: A randomized trial
Brief summary describing the background and objectives of the trial Ingrown toenail or onychocryptosis is a common condition mainly affecting the big toes. Ingrown toenail is mainly due to a conflict between the nail plate and the lateral nail fold which generates local inflammation, severe pain and restriction of daily activity. The main predisposing factors are: inadequate footwear, repetitive trauma or strain, nails cut too short or congenital anomalies of the nail. Despite the multiple surgical techniques described in the treatment of ingrown toenails, there is no consensus on the most appropriate method. Chemical Matricectomy using phenol 88% is a widely used technique, representing the "gold standard" in the treatment of ingrown toenails. It nevertheless induces an irreversible modification of the anatomy of the nail by reducing the width of the nail plate. Recently, the "gutter splint" method has been introduced in the treatment of ingrown toenails. It has the advantage of respecting the anatomy of the nail. The aim of this study was to compare the efficacy and tolerance of 2 techniques for treating ingrown toenails, namely the "Gutter Splint" method and chemical Matricectomy
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Skin and Connective Tissue Diseases,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/01/2021
Actual trial start date
Anticipated date of last follow up 31/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 112
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Chemical Matricectomy January 1st, 2021 - December 31, 2022 After local anesthesia, nail avultion is performed to expose the nail matrix. Cauterization of the nail matrix is performed using phenol 88% during 4mn. 56 Active-Treatment of Control Group
Experimental Group Gutter splint method January 1st, 2021 - December 2022 After local anesthesia, a gutter shaped flexible plastic tube obtained from a sterile serum infusion set is handled by forceps, brought to the edge of the nail groove and inserted proximally so as the lateral nail margin to settle in the gutter. The gutter splint is fixed using cyanoacrylate glue. 56
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Patients with a clinically diagnosed ingrown toenail - Age: 12-70 (years) - patients who gave their informed consent - patient who had previously undergone surgical matricectomy - patients who have one of these conditions: nail tumor, pincer nail, retronychia or onychomycosis Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Child: 6 Year-12 Year,Middle Aged: 45 Year(s)-64 Year(s) 12 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 22/02/2021 Comite Ethique local Hopital Charles Nicolle
Ethics Committee Address
Street address City Postal code Country
Boulevard du 9-Avril 1938 Tunis 1006 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Assessment of pain on day 7 after surgery using a visual analog scale (VAS) from 0 to 10 Day 7 after surgery
Secondary Outcome No discomfort when resuming daily activity day 7 after surgery
Secondary Outcome Recurrence as defined by the presence of a nail spicule or any sign of ingrowing nail within 4 months after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Dermatology Charles Nicolle hospital Boulevard du 9-Avril 1938 Tunis 1006 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hopital Charles Nicolle Boulevard du 9-Avril 1938 Tunis 1006 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
Chaima Massaoudi Boulevard du 9-Avril 1938 Tunis 1006 Tunisia
Pr Faten Zeglaoui Boulevard du 9-Avril 1938 Tunis 1006 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Noureddine Litaiem noureddine.litaiem@fmt.utm.tn +21652262531 Boulevard du 9-Avril 1938
City Postal code Country Position/Affiliation
Tunis Tunisia Assistant Professor
Role Name Email Phone Street address
Public Enquiries Chaima Massaoudi chaimamassaoudi00@gmail.com +21620113490 Boulevard du 9-Avril 1938
City Postal code Country Position/Affiliation
Tunis Tunisia Department of Dermatology Charles Nicolle Hospital
Role Name Email Phone Street address
Scientific Enquiries Faten Feglaoui Faten.zeglaoui@fmt.utm.tn +21698331112 Boulevard du 9-Avril 1938
City Postal code Country Position/Affiliation
Tunis Tunisia Department of Dermatology Charles Nicolle Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results after deindentification (text and tables) Study Protocol Beginning 9 months and ending 36 months after article publication Proposals may be submitted up to 36 months after article publication to Noureddine.litaiem@fmt.utm.tn. To gain access, data requestors should formulate a reasonable request. Requests will be reviewed by the medical committee of Charles Nicolle Hospital.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information