NCT04030754

Comparison of Effectiveness of Amniotic Membrane and Duoderm Dressings in Pediatric Burns

Comparison of Effectiveness of Amniotic Membrane and Duoderm Dressings in Pediatric Burn Patients: a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: King Edward Medical University · Academic / Other
• Sex: All
• Age: 1 Year – 12 Years
• Healthy volunteers: Not accepted

Summary

There is a difference in frequency of wound infection, mean pain score, mean of time for skin grafting and hospital stay in pediatric 2nd and 3rd degree burns, between amniotic membrane and duoderm dressings

Detailed description

After informed consent of the patients, patients who will fulfill the inclusion and exclusion criteria will be enrolled in the study from Department of Pediatric Surgery, Mayo Hospital Lahore and will be randomly allocated by lottery method into 2 groups by the doctor. Group A and B with 86 patients in each group. Group A patients will be undergoing amniotic membrane dressing, while group B patients will undergo colloid gel foam dressing. Basic demographic information will be noted. Effect modifiers (hemoglobin level, weight and height) will be noted. In group A, the wounds will be washed with normal saline and then covered with amniotic membrane over which a layer of Vaseline gauze will be applied and dressing with gauze and the crape bandage will be applied. Every 3-4 days these dressings will be changed and assessed for pain, wound infection and wound c/s will be sent. Placentas from clean vaginal deliveries and elective C-sections will be taken. Blood of mother will be screened. Amniotic membrane will be separated from placenta in a clean sterile bowl. Bowl will be put in refrigerator at 4 degrees. In group B, wound will be washed with normal saline . The wound site will be covered with Colloid Gel Foam and gauze, and crape bandage will be applied. Dressing will be changed after 3-4 days. The outcome (pain score, wound infection,time for skin grafting and hospital stay) will be compared in both groups.

Conditions

• Burns

Interventions

Type	Name	Description
COMBINATION_PRODUCT	amniotic membrane	amniotic membrane is a biological dressing
COMBINATION_PRODUCT	duoderm dressing	duoderm dressing is a synthetic dressing

Timeline

• Start date: 2018-11-01
• Primary completion: 2020-02-14
• Completion: 2020-02-14
• First posted: 2019-07-24
• Last updated: 2020-09-01

Locations

1 site across 1 country: Pakistan