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

Primary Purpose

Burns

Status
Completed
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
amniotic membrane
duoderm dressing
Sponsored by
King Edward Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring pediatric burns, dressings, amniotic membrane, duoderm

Eligibility Criteria

1 Year - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • King Edward Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

amniotic membrane group

duoderm group

Arm Description

amniotic dressing will be applied to these patients

duoderm dressing will be applied to these patients as intervention

Outcomes

Primary Outcome Measures

mean time for skin grafting
time for grafting when wound has healthy granulation tissue
frequency of wound infection
redness around burnt wound, tenderness, swelling, increased temperature (>4 degrees), exudation and growth on wound cultures
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
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.
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

Secondary Outcome Measures

Full Information

First Posted
February 26, 2019
Last Updated
August 31, 2020
Sponsor
King Edward Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04030754
Brief Title
Comparison of Effectiveness of Amniotic Membrane and Duoderm Dressings in Pediatric Burns
Official Title
Comparison of Effectiveness of Amniotic Membrane and Duoderm Dressings in Pediatric Burn Patients: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
February 14, 2020 (Actual)
Study Completion Date
February 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Edward Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
pediatric burns, dressings, amniotic membrane, duoderm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fatima naumeri, mbbs, fcps
Organizational Affiliation
King Edward Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Edward Medical University
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24354896
Citation
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.
Results Reference
background
PubMed Identifier
23523222
Citation
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.
Results Reference
background
PubMed Identifier
20223327
Citation
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.
Results Reference
background
PubMed Identifier
27308239
Citation
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.
Results Reference
background
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/?term=Eskandarlou+M%2C+Azimi+M%2C+Rabiee+S+and+Rabiee+MA
Description
about method of preparation and application of amniotic membrane

Learn more about this trial

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

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