Nail Bed Repair With or Without Nail Bed Coverage

Nail Bed Repair With or Without Nail Bed Coverage: Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Infection; Nail Bed Injury; Laceration Repair; Laceration Repair, Children
• Intervention / Treatment: Procedure: Nail Bed Repair with Nail Bed Coverage; Procedure: Nail Bed Repair without Nail Bed Coverage

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.

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75300
      • Patel hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: Nail 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; Other Names: Nail Plate Repositioning; Nail Bed Coverage
Active Comparator: No 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	Procedure: Nail 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; Other Names: No Nail Bed Coverage; Nail Plate Discarding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
infection	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	30 days

Collaborators and Investigators

• Sponsor: Patel Hospital, Pakistan

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): February 28, 2025

Study Registration Dates

• First Submitted: April 12, 2025
• First Submitted That Met QC Criteria: April 21, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: randomized clinical trial; nail bed repair; nail bed coverage; infection after nail bed repair; fingertip laceration; pediatric nail bed injury
• Additional Relevant MeSH Terms: Wounds and Injuries; Lacerations
• Other Study ID Numbers: PH/IRB/2023/042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: patient confidentiality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No