NCT02904941

Brief Summary

This is a randomised trial that aims to evaluate whether a transient skin cover made out of human amniotic membranes is effective in managing burns among pediatric patients. The primary outcome of this trial is the proportion of skin grafted amongst participants. Secondary outcomes include hospital stay and the number of surgical debridements required by included patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

6.3 years

First QC Date

September 4, 2016

Last Update Submit

November 4, 2020

Conditions

Burns

Keywords

ChildrenSkin TransplantationAmniotic Membrane

Outcome Measures

Primary Outcomes (1)

  • Total Grafted Skin Area

    Within the first 30 days after randomisation

Secondary Outcomes (2)

  • Length of Hospital Stay

    Within the first 45 days after randomisation.

  • Surgical Debridement

    Within the first 30 days after randomisation

Study Arms (2)

Amniotic Membrane Dressing

EXPERIMENTAL

Children allocated to this arm will receive skin dressings made out of human amniotic membrane. Dressings will be replaced every 72 - 96 hours.

Biological: Amniotic Membrane DressingProcedure: Standard Wound Care

Synthetic Dressing

ACTIVE COMPARATOR

Children allocated to this arm will receive skin dressings made out of silicone as part of their wound care. Dressings will be replaced every 72 - 96 hours.

Device: Synthetic DressingProcedure: Standard Wound Care

Interventions

Amniotic Membrane DressingBIOLOGICAL

Amniotic membrane dressings will be made out of donated amniotic membranes from elective cesarean sections. Screening for relevant infectious diseases and irradiation will be performed from every included sample in order to minimise infectious risks. Dressings will be provided to attending surgeons during wound care at the operating theatre and removed every 72-96 hours.

Amniotic Membrane Dressing
Synthetic DressingDEVICE

Silicone dressings will used as an active comparator in this study. As with the amniotic membrane, dressings will be applied to wound care at the operating room and replaced every 72 to 96 hours.

Also known as: Mepitel (R)
Synthetic Dressing
Standard Wound CarePROCEDURE

Every included participant will receive standard wound care regardless of treatment allocation. Contaminants such as clothes or other materials will be removed, and all burns will be cleaned using sterile saline solutions. Clorhexidine will also be used to clean the skin. Surgical debridement under general anesthesia or procedural sedation/analgesia will be performed to every included participant, in which nonviable tissues and blisters will be removed.

Amniotic Membrane DressingSynthetic Dressing

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with an acute burn (\<24 hours)
  • Burn due to hot liquids.
  • Total wound extension at least 5% of total body surface area.

You may not qualify if:

  • Burns due to fire, chemical burns or hot surfaces.
  • Delayed burns (\>24 hours).
  • Burns extending solely to the head or scalp.
  • Burns whose compromise of head or scalp is 50% or more of total burn area.
  • Refusal to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Carlos Van Buren

Valparaíso, 2341131, Chile

RECRUITING

Related Publications (5)

  • Selig HF, Lumenta DB, Giretzlehner M, Jeschke MG, Upton D, Kamolz LP. The properties of an "ideal" burn wound dressing--what do we need in daily clinical practice? Results of a worldwide online survey among burn care specialists. Burns. 2012 Nov;38(7):960-6. doi: 10.1016/j.burns.2012.04.007. Epub 2012 May 8.

    PMID: 22571855BACKGROUND

  • Fairbairn NG, Randolph MA, Redmond RW. The clinical applications of human amnion in plastic surgery. J Plast Reconstr Aesthet Surg. 2014 May;67(5):662-75. doi: 10.1016/j.bjps.2014.01.031. Epub 2014 Jan 31.

    PMID: 24560801BACKGROUND

  • Fraser JF, Cuttle L, Kempf M, Phillips GE, Hayes MT, Kimble RM. A randomised controlled trial of amniotic membrane in the treatment of a standardised burn injury in the merino lamb. Burns. 2009 Nov;35(7):998-1003. doi: 10.1016/j.burns.2009.01.003. Epub 2009 May 17.

    PMID: 19447551BACKGROUND

  • Bilic G, Zeisberger SM, Mallik AS, Zimmermann R, Zisch AH. Comparative characterization of cultured human term amnion epithelial and mesenchymal stromal cells for application in cell therapy. Cell Transplant. 2008;17(8):955-68. doi: 10.3727/096368908786576507.

    PMID: 19069637BACKGROUND

  • Vloemans AF, Hermans MH, van der Wal MB, Liebregts J, Middelkoop E. Optimal treatment of partial thickness burns in children: a systematic review. Burns. 2014 Mar;40(2):177-90. doi: 10.1016/j.burns.2013.09.016. Epub 2013 Nov 26.

    PMID: 24290852BACKGROUND

Related Links

MeSH Terms

Conditions

Burns

Interventions

Biological Dressings

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

BandagesEquipment and Supplies

Study Officials

  • sandramontedonico@gmail.com Montedonico, M.D.

    Servicio de Cirugía Pediátrica, Hospital Carlos Van Buren, Valparaíso, Chile

    STUDY DIRECTOR

  • Sebastián San Martín, Ph.D.

    Escuela de Medicina, Universidad de Valparaíso, Chile

    PRINCIPAL INVESTIGATOR

  • Felipe Martínez, M.D.

    Escuela de Medicina, Universidad de Valparaíso, Chile

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra Montedonico, M.D.

CONTACT

2364246sandramontedonico@gmail.com

Felipe Martinez, M.D; M.Sc.

CONTACT

99690952felipe.martinez@uv.cl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 4, 2016

First Posted

September 19, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

November 5, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)