InfectionNCT06949189
Nail Bed Repair With or Without Nail Bed Coverage
A study testing Nail Bed Repair with Nail Bed Coverage and Nail Bed Repair without Nail Bed Coverage in people with Infection and Laceration Repair, run by Patel Hospital, Pakistan at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infection, Laceration Repair, Laceration Repair, Children
- What is being tested?
- Nail Bed Repair with Nail Bed Coverage and Nail Bed Repair without Nail Bed Coverage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Nail Bed Repair with Nail Bed Coverage, Nail Bed Repair without Nail Bed Coverage
- Keywords
- nail bed repair, nail bed coverage, infection after nail bed repair, fingertip laceration, pediatric nail bed injury, randomized clinical trial
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nail Bed Repair with Nail Bed CoverageProcedure or surgery
Also called Nail Plate Repositioning, 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
Nail Bed Repair without Nail Bed CoverageProcedure or surgery
Also called No Nail Bed Coverage, Nail Plate Discarding
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Nail Bed Repair without Nail Bed Coverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start1 Mar 2024
- Primary completion28 Feb 2025
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Patel Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osheen Abbasi, Patel Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949189
- Sponsor's protocol ID
- PH/IRB/2023/042
- Status last verified
- Apr 2025
- First submitted
- 12 Apr 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: patient confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nail Bed Repair With or Without Nail Bed Coverage: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06949189
- Acronym / sponsor ID
- PH/IRB/2023/042
- Keywords
- nail bed repair, nail bed coverage, infection after nail bed repair, fingertip laceration, pediatric nail bed injury, randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Patel Hospital, PakistanUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nail bed coverage | Experimental | Procedure: Nail Bed Repair with Nail Bed CoverageFollowing 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 |
| No Nail Bed Coverage | Active comparator | Procedure: Nail Bed Repair without Nail Bed CoverageFollowing 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- Infected injuries,
- Underlying nail diseases,
- Pre-existing deformities in the injured or contralateral finger,
- Distal phalanx fractures requiring fixation,
- Amputations,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nail Bed Repair with Nail Bed CoverageAlso: Nail Plate Repositioning, Nail Bed CoverageFollowing 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 or surgery | nail bed coverage |
| Nail Bed Repair without Nail Bed CoverageAlso: No Nail Bed Coverage, Nail Plate DiscardingFollowing 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 or surgery | No Nail Bed Coverage |
Primary outcome
infection
Time frame: 30 days
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: No. patient confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nail Bed Repair with Nail Bed Coverage and Nail Bed Repair without Nail Bed Coverage in people with Infection and Laceration Repair, run by Patel Hospital, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
infection (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025; AzTrials last refreshed its copy on 31 Oct 2026.