Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06380647
Acronym
childburn
Enrollment
64
Registered
2024-04-24
Start date
2019-10-01
Completion date
2020-09-30
Last updated
2024-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes Virus Infection

Keywords

Eczema herpeticum, pediatric burns, Acyclovir, Prophylaxis

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.

Interventions

DRUGIntravenous 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.

Sponsors

King Edward Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

parents were blinded to group allocation

Intervention model description

Sample size of 64 patients (32 patients in each group) was estimated by using 5% level of significance, 90% power of test with expected percentage of patients given prophylactic acyclovir as 81.3% and patients given placebo as 42.9%.

Eligibility

Sex/Gender
ALL
Age
1 Months to 13 Years
Healthy volunteers
No

Inclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with positive Tzanck smear1 yearProphylactic acyclovir was compared with placebo regarding preventing eczema herpeticum prophylactically

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026