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OpenTrials
Completed

NCT Number: NCT06380647

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

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

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Key information

Age range

1 month–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

department of pediatric surgery King Edward Medical University

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Intravenous Acyclovir

Drug

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.

Primary outcomes

  1. Number of participants with positive Tzanck smear

    Time frame: 1 year

    Prophylactic acyclovir was compared with placebo regarding preventing eczema herpeticum prophylactically

Sponsors and collaborators

Lead sponsor

King Edward Medical University

Other

Registry information

Acronym: childburn

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 24, 2024
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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