Clinical trial NCT06949189: Nail Bed Repair With or Without Nail Bed Coverage
Official title: Nail Bed Repair With or Without Nail Bed Coverage: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infection
Laceration Repair
Laceration Repair, Children
Nail Bed Injury
Keywords: nail bed repair
nail bed coverage
infection after nail bed repair
fingertip laceration
pediatric nail bed injury
randomized clinical trial
Lead sponsor: Patel Hospital, Pakistan
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 152
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: infection
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Patel Hospital
state: Sindh
Study officials:
References: