Comparison of Prophylactic Acyclovir and Placebo in Prevention of Eczema Herpeticum in Pediatric Burns (childburn)

April 17, 2024 updated by: Muhammad Sharif, King Edward Medical University

Introduction: Early detection is important in treating patients with Eczema Herpeticum (EH), which may arise in paediatric burn patients. As soon as a clinical diagnosis is confirmed, antiviral medications should be started to ensure an early resolution of the disease. Several studies have indicated that acyclovir is the best treatment for EH lesions in the majority of individuals.

Objective: Compare efficacy of the prophylactic acyclovir and placebo in preventing eczema Herpeticum in paediatric burn patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Materials and Methods Study design: Randomised control trial. Setting: Pediatric burn unit Mayo hospital Lahore Duration: 1st October 2019 to 30th September 2020. Data collection procedure: All the patients were managed with intravenous fluids, antibiotics, antipyretics and hydrocolloid dressing as per ward routine management protocol along with prophylactic acyclovir and placebo. On the zero day of admission, after parents provided informed consent, patients were randomly assigned to one of two groups using a computer-generated table. Group A patients were given intra venous acyclovir divided into three doses for 7 to 14 days during their stay. Group B patients were given 15% intravenous Hypertonic sodium chloride divided into three doses as placebo for 7 to 14 days, so that parents could be blinded to group allocation. Patients were observed for developing signs of eczema Herpeticum and Tzanck smear was done every 10th day and first follow up at outpatient department after 7days of discharge.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • department of pediatric surgery King Edward Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

  • age 1 month to ≤ 13 years .10 to 60 percent total body surface area (TBSA) burn.

  • 2nd and 3rd degree burn Exclusion Criteria

    • Patients having previous history of skin disease.
    • Patients having any Comorbidity e.g. Psoriasis, asthma, atopic dermatitis and conjunctivitis.
    • Immunocompromised patients.
    • Patients on steroids or chemotherapy.
    • Patients already having eczema Herpeticum and positive baseline Tzanck smear

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A(32 patients)
Group A patients were given intra venous acyclovir at dosage of 5-10 mg/kg/day into three doses for 7-14 days during their stay.Giant smear testing was done from suspected lesion on burn area to confirm viral infection
Drug: Intravenous Acyclovir
Patients were observed for developing signs of eczema herpeticum and Tzanck smear was done every 10th day and first follow up at OPD after 7days of discharge following ward management protocol. If prophylactic acyclovir was efficacious then no eczema herpeticum developed. Patients who develop eczema herpeticum were isolated and were treated with injection acyclovir 15 to 30 mg/kg/day into three divided doses for 10 to 14 days.
Placebo Comparator: Group B (32 patients)
Group B patients were given intravenous normal saline 5-10 mg/kg into three doses as placebo for 7 to 14 days,Giant smear testing was done from suspected lesion on burn area to confirm viral infection
Drug: Intravenous Acyclovir
Patients were observed for developing signs of eczema herpeticum and Tzanck smear was done every 10th day and first follow up at OPD after 7days of discharge following ward management protocol. If prophylactic acyclovir was efficacious then no eczema herpeticum developed. Patients who develop eczema herpeticum were isolated and were treated with injection acyclovir 15 to 30 mg/kg/day into three divided doses for 10 to 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with positive Tzanck smear
Time Frame: 1 year
Prophylactic acyclovir was compared with placebo regarding preventing eczema herpeticum prophylactically
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Edward Medical University

Investigators

  • Study Chair: Muhammad Sharif, King Edward Medical University/Mayo Hospital Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

March 31, 2024

First Submitted That Met QC Criteria

April 17, 2024

First Posted (Actual)

April 24, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

will be shared on request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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