- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07286851
Do Topical Antibiotics Improve Skin Graft Results?
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:
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Dinajpur
-
Parbatipur, Dinajpur, Bangladesh, 5250
- LAMB Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- patient undergoing a split-thickness skin graft at the hospital where research is conducted
Exclusion Criteria:
- Missing or incomplete medical record
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
Topical neomycin was applied at the time of split-thickness skin graft surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Skin graft take
Time Frame: Measured at the time of discharge from the patient's initial post-operative hospitalization, which averaged 20 days.
|
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 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).
|
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."
|
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.
|
Number of days spent in the hospital during the initial post-operative period.
|
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.
|
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 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.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC2025/03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
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