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Trial record 1 of 1 for:    NCT04030754
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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
Sponsor:
Information provided by (Responsible Party):
Fatima Numeri, King Edward Medical University

Brief 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

Condition or disease Intervention/treatment Phase
Burns Combination Product: amniotic membrane Combination Product: duoderm dressing Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
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




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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Pakistan
King Edward Medical University
Lahore, Punjab, Pakistan, 54000
Sponsors and Collaborators
King Edward Medical University
Investigators
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Principal Investigator: fatima naumeri, mbbs, fcps King Edward Medical University
Additional Information:
Publications:
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Responsible Party: Fatima Numeri, Assistant Professor, King Edward Medical University
ClinicalTrials.gov Identifier: NCT04030754    
Other Study ID Numbers: 257/RC/KEMU
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fatima Numeri, King Edward Medical University:
pediatric burns, dressings, amniotic membrane, duoderm
Additional relevant MeSH terms:
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Burns
Wounds and Injuries