NCT04030754

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 24, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2020

Completed
Last Updated

September 1, 2020

Status Verified

August 1, 2020

Enrollment Period

1.3 years

First QC Date

February 26, 2019

Last Update Submit

August 31, 2020

Conditions

Burns

Keywords

pediatric burns, dressings, amniotic membrane, duoderm

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

amniotic membrane group

EXPERIMENTAL

amniotic dressing will be applied to these patients

Combination Product: amniotic membrane

duoderm group

EXPERIMENTAL

duoderm dressing will be applied to these patients as intervention

Combination Product: duoderm dressing

Interventions

amniotic membraneCOMBINATION_PRODUCT

amniotic membrane is a biological dressing

amniotic membrane group
duoderm dressingCOMBINATION_PRODUCT

duoderm dressing is a synthetic dressing

duoderm group

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • % percent 2nd and 3rd degree fresh burns age less than 12 years patients of both gender

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Edward Medical University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (4)

  • 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.

    PMID: 24354896BACKGROUND

  • 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.

    PMID: 23523222BACKGROUND

  • 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.

    PMID: 20223327BACKGROUND

  • 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.

    PMID: 27308239BACKGROUND

Related Links

MeSH Terms

Conditions

Burns

Interventions

Biological Dressings

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

BandagesEquipment and Supplies

Study Officials

  • fatima naumeri, mbbs, fcps

    King Edward Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 26, 2019

First Posted

July 24, 2019

Study Start

November 1, 2018

Primary Completion

February 14, 2020

Study Completion

February 14, 2020

Last Updated

September 1, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)