Skin TransplantationNCT07286851
Do Topical Antibiotics Improve Skin Graft Results?
An observational study of Skin Transplantation and Wounds and Injuries, run by LAMB Project at 1 site in Bangladesh.
Trial summary
The goal of this study is to see if putting antibiotic ointment on a skin graft when the surgery is being done helps prevent the skin graft from getting infected after the operation. The study is looking at all skin grafts done in a rural Bangladesh hospital. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Skin Transplantation, Wounds and Injuries, Antibiotic Prophylaxis Surgery
- What is being tested?
- Neomycin
- How many people
- 142 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Dec 2024to 31 Aug 2025
- Phase
- Observational
- 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
Study population: Patients with wounds undergoing split-thickness skin graft surgery at a single rural hospital in Bangladesh.
Who may be able to join
- patient undergoing a split-thickness skin graft at the hospital where research is conducted
Who cannot join
- Missing or incomplete medical record
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Topical Neomycin on Skin Graft Outcomes in Rural Bangladesh: a Retrospective Cohort Study
The goal of this study is to see if putting antibiotic ointment on a skin graft when the surgery is being done helps prevent the skin graft from getting infected after the operation. The study is looking at all skin grafts done in a rural Bangladesh hospital.
The main questions it aims to answer are:
Read more
Does the antibiotic lower the number of infections that happen? Does the antibiotic make the overall outcome of the skin graft better? Do patients who get the antibiotic need fewer extra surgeries?
Researchers will compare the outcomes from patients who had skin grafts before the hospital started applying antibiotic ointment to the outcomes of patients after the hospital began applying antibiotic ointment.
Participants who have already had their skin graft treatment completed will have their medical records reviewed by researchers. The outcomes of their treatment will be written down.
- Being tested
- Neomycin
- Keywords
- bangladesh, developing countries
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeomycinDrug
Topical neomycin was applied at the time of split-thickness skin graft surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control | Patients who had skin graft procedure before the topical antibiotic protocol was initiated | |
| Neomycin | Patients who had skin graft procedure after the topical antibiotic protocol was initiated. Patients had topical neomycin applied at the time of their surgeries. Receives: Drug: Neomycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative infection rate
Whether patients had post-operative infection during their hospitalization, classified as "yes" or "no" as defined by any of the following being present: "post-operative infection" diagnosis written in the patient's medical record, change or increase in antibiotic therapy post-operatively, or the presence of pus documented at the skin graft site.
Measured: Measured if present at any time during the patient's initial post-operative hospitalization, which averaged 20 days, from time of operation until time of discharge.
Secondary outcomes (4)
Skin graft take
Percentage of skin graft that remained intact at the time of discharge, as estimated by the treating surgeon and documented in the patient's record.
Measured: Measured at the time of discharge from the patient's initial post-operative hospitalization, which averaged 20 days.
Need for operative re-intervention
Whether patient needed to return to the operating room for additional procedures (such as debridement or repeat skin grafting) for the same wound, classified as "yes" or "no."
Measured: From the time of operation until the end of the study period (up to three years for the earliest skin graft patients).
Length of stay
Number of days spent in the hospital during the initial post-operative period.
Measured: Measured at the time of discharge from the patient's initial post-operative hospitalization, which averaged 20 days.
Allergic reaction
Whether patient had any allergic reaction to neomycin or any other substance documented - categorized as "yes" or "no," based on the new presentation of rash or pruritis.
Measured: Measured if present at any time during the patient's initial post-operative hospitalization, which averaged 20 days, from time of operation until time of discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Dec 2024
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin TransplantationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- LAMB Project
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Egle, LAMB Project
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286851
- Sponsor's protocol ID
- REC2025/03
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication may be available upon reasonable request if the study is published in a peer-reviewed journal.
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Topical Neomycin on Skin Graft Outcomes in Rural Bangladesh: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07286851
- Acronym / sponsor ID
- REC2025/03
- Keywords
- bangladesh, developing countries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- LAMB ProjectUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 16 Dec 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.
The goal of this study is to see if putting antibiotic ointment on a skin graft when the surgery is being done helps prevent the skin graft from getting infected after the operation. The study is looking at all skin grafts done in a rural Bangladesh hospital.
The main questions it aims to answer are:
Does the antibiotic lower the number of infections that happen? Does the antibiotic make the overall outcome of the skin graft better? Do patients who get the antibiotic need fewer extra surgeries?
Researchers will compare the outcomes from patients who had skin grafts before the hospital started applying antibiotic ointment to the outcomes of patients after the hospital began applying antibiotic ointment.
Participants who have already had their skin graft treatment completed will have their medical records reviewed by researchers. The outcomes of their treatment will be written down.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Patients who had skin graft procedure before the topical antibiotic protocol was initiated |
| Neomycin | – | Drug: NeomycinPatients who had skin graft procedure after the topical antibiotic protocol was initiated. Patients had topical neomycin applied at the time of their surgeries. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with wounds undergoing split-thickness skin graft surgery at a single rural hospital in Bangladesh.
Key inclusion criteria (1 listed)
- patient undergoing a split-thickness skin graft at the hospital where research is conducted
Key exclusion criteria (1 listed)
- Missing or incomplete medical record
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 |
|---|---|---|
| NeomycinTopical neomycin was applied at the time of split-thickness skin graft surgery. | Drug | Neomycin |
Primary outcome
Post-operative infection rate
Time frame: Measured if present at any time during the patient's initial post-operative hospitalization, which averaged 20 days, from time of operation until time of discharge.
Whether patients had post-operative infection during their hospitalization, classified as "yes" or "no" as defined by any of the following being present: "post-operative infection" diagnosis written in the patient's medical record, change or increase in antibiotic therapy post-operatively, or the presence of pus documented at the skin graft site.
4 secondary outcomes
Skin graft take
Time frame: Measured at the time of discharge from the patient's initial post-operative hospitalization, which averaged 20 days.
Need for operative re-intervention
Time frame: From the time of operation until the end of the study period (up to three years for the earliest skin graft patients).
Length of stay
Time frame: Measured at the time of discharge from the patient's initial post-operative hospitalization, which averaged 20 days.
Allergic reaction
Time frame: Measured if present at any time during the patient's initial post-operative hospitalization, which averaged 20 days, from time of operation until time of discharge.
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 16 Dec 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication may be available upon reasonable request if the study is published in a peer-reviewed journal.
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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?
An observational study of Skin Transplantation and Wounds and Injuries, run by LAMB Project at 1 site in Bangladesh.
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 1 inclusion and 1 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 16 Dec 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 Bangladesh. 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?
Post-operative infection rate (time frame: Measured if present at any time during the patient's initial post-operative hospitalization, which averaged 20 days, from time of operation until time of discharge.). 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 16 Dec 2025.