Nail Bed Repair With or Without Nail Bed Coverage

NCT06949189 | Completed

• 1 other identifier: PH/IRB/2023/042
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

nail bed coverage

EXPERIMENTAL

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

No Nail Bed Coverage

ACTIVE COMPARATOR

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

Interventions

Nail Bed Repair with Nail Bed Coverage PROCEDURE

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

Also known as: Nail Plate Repositioning, Nail Bed Coverage

nail bed coverage

Nail Bed Repair without Nail Bed Coverage PROCEDURE

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

Also known as: No Nail Bed Coverage, Nail Plate Discarding

No Nail Bed Coverage

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Patel Hospital, Pakistan: lead

Study Sites (1)

Patel Hospital

Karachi, Sindh, 75300, Pakistan

Location

MeSH Terms

Conditions

Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Plastic Surgery, Patel Hospital, Karachi

Study Record Dates

• First Submitted: April 12, 2025
• First Posted: April 29, 2025
• Study Start: March 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)