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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2020-02-14

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

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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.

Conditions

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Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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amniotic membrane group

amniotic dressing will be applied to these patients

Group Type EXPERIMENTAL

amniotic membrane

Intervention Type COMBINATION_PRODUCT

amniotic membrane is a biological dressing

duoderm group

duoderm dressing will be applied to these patients as intervention

Group Type EXPERIMENTAL

duoderm dressing

Intervention Type COMBINATION_PRODUCT

duoderm dressing is a synthetic dressing

Interventions

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amniotic membrane

amniotic membrane is a biological dressing

Intervention Type COMBINATION_PRODUCT

duoderm dressing

duoderm dressing is a synthetic dressing

Intervention Type COMBINATION_PRODUCT

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.

Minimum Eligible Age

1 Year

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No