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Completed

NCT Number: NCT04030754

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

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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Key information

Conditions

Burns Wounds and Injuries

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

King Edward Medical University

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

amniotic membrane

Combination Product

amniotic membrane is a biological dressing

duoderm dressing

Combination Product

duoderm dressing is a synthetic dressing

Primary outcomes

  1. mean time for skin grafting

    Time frame: average time will be 21 days

    time for grafting when wound has healthy granulation tissue

  2. frequency of wound infection

    Time frame: at 5th day of dressing

    redness around burnt wound, tenderness, swelling, increased temperature (>4 degrees), exudation and growth on wound cultures

  3. mean of hospital stay

    Time frame: at the time of discharge, that can be from 7th day to 30th day

    time at which patient wound is completely healed and no wound infection present, average time will be up to 30 days

  4. mean of pain for patients of age <8 years assessed by Visual Analogue Score

    Time frame: at 5th day of dressing change

    pain will be assessed at the time of dressing change. for patients<8 years of age visual analogue score will be used.

  5. mean of pain for patients of age >8 years assessed by Face, Leg, Activity, Cry, Consolabilty Pain Scale.

    Time frame: at 5th day of dressing change

    FLACC (face,leg, activity, cry, consolability) pain scale will be used

Sponsors and collaborators

Lead sponsor

King Edward Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 24, 2019
Registry last updated
Sep 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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