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

King Edward Medical University

Status: Completed

Conditions: Herpes Virus Infection

Treatments: Drug: Intravenous Acyclovir

Study type: Interventional

Funder types: Other

Identifiers

NCT06380647

0004

Details and patient eligibility

About

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

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 1 month to 13 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

64 participants in 2 patient groups, including a placebo group

Group A(32 patients)

Experimental group

Description:

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

Treatment:

Drug: Intravenous Acyclovir

Group B (32 patients)

Placebo Comparator group

Description:

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

Treatment:

Drug: Intravenous Acyclovir