Infection, Laceration Repair, Laceration Repair, Children, Nail Bed Injury
Conditions
Keywords
nail bed repair, nail bed coverage, infection after nail bed repair, fingertip laceration, pediatric nail bed injury, randomized clinical trial
Brief summary
A randomized clinical trial conducted at Patel hospital, Karachi, from March 2024 to February 2025, to evaluate infection in patients undergoing nailbed repair with and without nailbed coverage, with minimum follow up for one month post operative.
Detailed description
Background: The fingernail serves as a protective barrier for the dorsal fingertip while also enhancing its aesthetic appeal. Fingertip injuries account for approximately two-thirds of pediatric hand injuries, with nail bed injuries comprising 15% to 24% of these cases. In the United Kingdom, 96% of surgeons routinely remove the nail plate, repair the nail bed, and reposition the nail plate onto the nail bed. The rationale for repositioning includes protecting the repair, reducing infection risk, minimizing pain during dressing changes, and preventing adhesions by supporting the nail fold. When the autologous nail is unavailable, alternatives such as silver foil is used. Objective: This study aims to evaluate the risk of surgical site infection after nail bed repair with and without nail bed coverage. Methods: This is a two-arm randomized clinical trial enrolling 152 patients (76 in each group) over a 12-month period from March 2024 to February 2025. Patients undergoing nail bed repair will be randomized into two groups-one receiving nail bed coverage (repositioned nail or substitute) and the other without coverage. The primary outcome is the incidence of surgical site infection. Secondary outcomes include pain during dressing changes and cosmetic results.
Interventions
PROCEDURENail Bed Repair with Nail Bed Coverage
Following debridement and suturing of the nail bed, the fingernail will be replaced and secured with a figure-of-eight suture using Prolene. A low-adherent dressing will be applied. If the fingernail is unavailable (e.g., due to damage or loss), a substitute material (such as foil) will be chosen by the operating surgeon
PROCEDURENail Bed Repair without Nail Bed Coverage
Following debridement and suturing of the nail bed, the fingernail will be discarded. A low-adherent dressing will be applied without any covering of the nail bed
Sponsors
Patel Hospital, Pakistan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients of all age groups and genders, * Presented to the emergency or outpatient department within 48 hours of injury, * Provided written informed consent (or had consent given by a parent/guardian in the case of minors), * Injury to a single finger, * Fractures that do not involve an open wound or require fixation.
Exclusion criteria
* Infected injuries, * Underlying nail diseases, * Pre-existing deformities in the injured or contralateral finger, * Distal phalanx fractures requiring fixation, * Amputations, * Partial or complete loss of the nail bed requiring reconstruction, * Multiple nail bed injuries, * Known allergies to prescribed postoperative medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| infection | 30 days | Surgical site infection (SSI) was diagnosed according to CDC guidelines, requiring at least two of the following criteria within 30 days postoperatively: * Purulent discharge * Pain, with a numerical pain scale value of 7 or greater considered positive * Swelling * Erythema, defined as visible redness extending beyond the distal interphalangeal joint compared to the contralateral finger * Tenderness, characterized by pain upon touch |
Countries
Pakistan
Outcome results
None listed