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

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

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

Study Overview

• Status: Completed
• Conditions: Burns
• Intervention / Treatment: Combination product: amniotic membrane; Combination product: duoderm dressing

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.

• Study Type: Interventional
• Enrollment (Actual): 172
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • King Edward Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean time for skin grafting	time for grafting when wound has healthy granulation tissue	average time will be 21 days
frequency of wound infection	redness around burnt wound, tenderness, swelling, increased temperature (>4 degrees), exudation and growth on wound cultures	at 5th day of dressing
mean of hospital stay	time at which patient wound is completely healed and no wound infection present, average time will be up to 30 days	at the time of discharge, that can be from 7th day to 30th day
mean of pain for patients of age <8 years assessed by Visual Analogue Score	pain will be assessed at the time of dressing change. for patients<8 years of age visual analogue score will be used.	at 5th day of dressing change
mean of pain for patients of age >8 years assessed by Face, Leg, Activity, Cry, Consolabilty Pain Scale.	FLACC (face,leg, activity, cry, consolability) pain scale will be used	at 5th day of dressing change

Collaborators and Investigators

• Sponsor: King Edward Medical University
• Investigators: Principal Investigator: fatima naumeri, mbbs, fcps, King Edward Medical University

Publications and helpful links

General Publications

• 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.

Helpful Links

• about method of preparation and application of amniotic membrane

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): February 14, 2020
• Study Completion (Actual): February 14, 2020

Study Registration Dates

• First Submitted: February 26, 2019
• First Submitted That Met QC Criteria: July 23, 2019
• First Posted (Actual): July 24, 2019

Study Record Updates

• Last Update Posted (Actual): September 1, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: pediatric burns, dressings, amniotic membrane, duoderm
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 257/RC/KEMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No