Do Topical Antibiotics Improve Skin Graft Results?

NCT07286851 | Completed

• 1 other identifier: REC2025/03
• Study Type: observational
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Skin Transplantation; Wounds and Injuries; Antibiotic Prophylaxis Surgery

Keywords

bangladesh; developing countries

Outcome Measures

Primary Outcomes (1)

• 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 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

  Measured at the time of discharge from the patient's initial post-operative hospitalization, which averaged 20 days.

• Need for operative re-intervention

  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

  Measured at the time of discharge from the patient's initial post-operative hospitalization, which averaged 20 days.

• Allergic reaction

  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.

Study Arms (2)

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.

Drug: Neomycin

Interventions

Neomycin DRUG

Topical neomycin was applied at the time of split-thickness skin graft surgery.

Neomycin

Eligibility Criteria

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

Study Population

Patients with wounds undergoing split-thickness skin graft surgery at a single rural hospital in Bangladesh.

You may qualify if:

• patient undergoing a split-thickness skin graft at the hospital where research is conducted

You may not qualify if:

• Missing or incomplete medical record

Sponsors & Collaborators

• LAMB Project: lead

Study Sites (1)

LAMB Hospital

Parbatipur, Dinajpur, 5250, Bangladesh

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Neomycin

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgeon, Deputy Medical Director

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 16, 2025
• Study Start: December 1, 2024
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: This IPD will be available beginning when the study is published and will be available while the authors continue to be affiliated with the institution where the study has taken place.
• Access Criteria: The request for sharing of data must be reviewed by the LAMB Project Research Ethics Committee, which will make all final decisions about the sharing of individual patient data.

Locations

BA (1)