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

Not Applicable

Completed

• Conditions: Herpes Virus Infection
• Interventions: Drug: Intravenous Acyclovir

• Registration Number: NCT06380647
• Lead Sponsor: King Edward Medical University

Brief Summary

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

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 Timeline

• Study Start: 2019-10-01
• Primary Completion: 2020-09-30
• Study Completion: 2020-09-30
• Study First Submitted: 2024-03-31
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-17
• Last Update Submitted: 2024-04-17
• Study First Posted: 2024-04-24
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A(32 patients)	Intravenous Acyclovir	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
Group B (32 patients)	Intravenous Acyclovir	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

Primary Outcome Measures

Name	Time	Method
Number of participants with positive Tzanck smear	1 year	Prophylactic acyclovir was compared with placebo regarding preventing eczema herpeticum prophylactically

Trial Locations

Locations (1)

department of pediatric surgery King Edward Medical University; 🇵🇰 Lahore, Punjab, Pakistan