Clinical trial NCT06380647: Comparison of Prophylactic Acyclovir and Placebo in Prevention of Eczema Herpeticum in Pediatric Burns
Official title: Comparison of Prophylactic Acyclovir and Placebo in Prevention of Eczema Herpeticum in Pediatric Burns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Herpes Virus Infection
Keywords: Eczema herpeticum
pediatric burns
Acyclovir
Prophylaxis
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 64
Sex: ALL
Minimum age (years): 1
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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%.
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Number of participants with positive Tzanck smear
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: department of pediatric surgery King Edward Medical University
state: Punjab
Study officials:
affiliation: King edward Medical University/Mayo Hospital Lahore
name: Muhammad Sharif
role: STUDY_CHAIR
References: