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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Burns

Intervention / Treatment
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* Combination Product: amniotic membrane
* Combination Product: duoderm dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 10-45 % percent 2nd and 3rd degree fresh burns age less than 12 years patients of both gender Exclusion Criteria: patients whose parents are not willing patients whose wound c/s comes positive at the time of admission patients who have associated medical disorder and trauma.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: amniotic membrane group<br>amniotic dressing will be applied to these patients | Combination Product: amniotic membrane<br>* amniotic membrane is a biological dressing<br>|
| Experimental: duoderm group<br>duoderm dressing will be applied to these patients as intervention | Combination Product: duoderm dressing<br>* duoderm dressing is a synthetic dressing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean time for skin grafting | time for grafting when wound has healthy granulation tissue | average time will be 21 days | 
| frequency of wound infection | redness around burnt wound, tenderness, swelling, increased temperature (>4 degrees), exudation and growth on wound cultures | at 5th day of dressing | 
| mean of hospital stay | time at which patient wound is completely healed and no wound infection present, average time will be up to 30 days | at the time of discharge, that can be from 7th day to 30th day | 
| mean of pain for patients of age <8 years assessed by Visual Analogue Score | pain will be assessed at the time of dressing change. for patients<8 years of age visual analogue score will be used. | at 5th day of dressing change | 
| mean of pain for patients of age >8 years assessed by Face, Leg, Activity, Cry, Consolabilty Pain Scale. | FLACC (face,leg, activity, cry, consolability) pain scale will be used | at 5th day of dressing change | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric burns, dressings, amniotic membrane, duoderm