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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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:
| 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Patel Hospital | Karachi | Sindh | 75300 | Pakistan |
patient confidentiality
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| ID | Term |
|---|---|
| D007239 | Infections |
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| 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 |
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