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

Overview

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

Full Title of Study: “Comparison of Effectiveness of Amniotic Membrane and Duoderm Dressings in Pediatric Burn Patients: a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: February 14, 2020

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.

Interventions

  • Combination Product: amniotic membrane
    • amniotic membrane is a biological dressing
  • Combination Product: duoderm dressing
    • duoderm dressing is a synthetic dressing

Arms, Groups and Cohorts

  • Experimental: amniotic membrane group
    • amniotic dressing will be applied to these patients
  • Experimental: duoderm group
    • duoderm dressing will be applied to these patients as intervention

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • King Edward Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Fatima Numeri, Assistant Professor – King Edward Medical University
  • Overall Official(s)
    • fatima naumeri, mbbs, fcps, Principal Investigator, King Edward Medical University

References

Al Ibran E, Mirza FH, Memon AA, Farooq MZ, Hassan M. Mortality associated with burn injury – a cross sectional study from Karachi, Pakistan. BMC Res Notes. 2013 Dec 19;6:545. doi: 10.1186/1756-0500-6-545.

Mohammadi AA, Johari HG, Eskandari S. Effect of amniotic membrane on graft take in extremity burns. Burns. 2013 Sep;39(6):1137-41. doi: 10.1016/j.burns.2013.01.017. Epub 2013 Mar 21.

Martin FT, O'Sullivan JB, Regan PJ, McCann J, Kelly JL. Hydrocolloid dressing in pediatric burns may decrease operative intervention rates. J Pediatr Surg. 2010 Mar;45(3):600-5. doi: 10.1016/j.jpedsurg.2009.09.037.

Eskandarlou M, Azimi M, Rabiee S, Seif Rabiee MA. The Healing Effect of Amniotic Membrane in Burn Patients. World J Plast Surg. 2016 Jan;5(1):39-44.

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