Comparison of Effectiveness of Amniotic Membrane and Duoderm Dressings in Pediatric Burns
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|ClinicalTrials.gov Identifier: NCT04030754|
Recruitment Status : Completed
First Posted : July 24, 2019
Last Update Posted : September 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Burns||Combination Product: amniotic membrane Combination Product: duoderm dressing||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||172 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Comparison of Effectiveness of Amniotic Membrane and Duoderm Dressings in Pediatric Burn Patients: a Randomized Controlled Trial|
|Actual Study Start Date :||November 1, 2018|
|Actual Primary Completion Date :||February 14, 2020|
|Actual Study Completion Date :||February 14, 2020|
Experimental: amniotic membrane group
amniotic dressing will be applied to these patients
Combination Product: amniotic membrane
amniotic membrane is a biological dressing
Experimental: duoderm group
duoderm dressing will be applied to these patients as intervention
Combination Product: duoderm dressing
duoderm dressing is a synthetic dressing
- mean time for skin grafting [ Time Frame: average time will be 21 days ]time for grafting when wound has healthy granulation tissue
- 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
- 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
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04030754
|King Edward Medical University|
|Lahore, Punjab, Pakistan, 54000|
|Principal Investigator:||fatima naumeri, mbbs, fcps||King Edward Medical University|