Nail Bed Repair With or Without Nail Bed Coverage

Patel Hospital, Pakistan

Status: Completed

Conditions: Infection; Nail Bed Injury; Laceration Repair, Children; Laceration Repair

Treatments: Procedure: Nail Bed Repair with Nail Bed Coverage; Procedure: Nail Bed Repair without Nail Bed Coverage

Study type: Interventional

Funder types: Other

Identifiers

NCT06949189

PH/IRB/2023/042

Details and patient eligibility

About

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.

Full 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.

Enrollment: 152 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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152 participants in 2 patient groups

nail bed coverage

Experimental group

Description:

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

Treatment:

Procedure: Nail Bed Repair with Nail Bed Coverage

No Nail Bed Coverage

Active Comparator group

Description:

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

Treatment:

Procedure: Nail Bed Repair without Nail Bed Coverage