Human Amniotic Versus Synthetic Membrane as a Transient Skin Cover for Pediatric Burns

Human Amniotic Versus Synthetic Membrane as a Transient Skin Cover for Pediatric Burns: A Randomised Trial

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.

Study Overview

• Status: Unknown
• Conditions: Burns
• Intervention / Treatment: Biological: Amniotic Membrane Dressing; Procedure: Standard Wound Care; Device: Synthetic Dressing

Detailed Description

Patients with burns that compromise 5% or more of total body surface area will be randomised to receive a membrane made out of human amnios or a synthetic cover for the acute phase of care. Eligible participants will be children with acute burns (<24 hours) due to hot liquids that compromise 5% or more of total body surface area.

Patients with burns due to fire, hot surfaces or chemical agents, those with delayed presentation to the emergency department (>24 hours), and patients with burns that compromise the head or scalp (exclusively or in cases where this compromise exceeds 50% of the total body surface area affected by the burn). Patients whose parents do not authorise participation in this trial will also be excluded.

Randomisation will be performed by a statistician unaware of the clinical management of included patients. The specific allocation sequence will be kept hidden from other investigators. Patients, outcome assessors and statisticians will also be kept unaware of treatment allocation. Blinding will be achieved by using image analysis software to assess the primary endpoint. Due to the intervention's characteristics, it will be impossible to perform blinding of the attending surgeon. Analyses will be performed under the intention - to - treat principle.

Amniotic membrane samples will be collected by personnel that shall not provide care for included participants. Samples suitable for donation will come from elective caesarean sections. Once obtained, amniotic membranes will be stored in sterile containers and then sent for irradiation at a facility provided by the Comisión Chilena de Energía Nuclear (Chilean Nuclear Energy Comission). This sampling protocol includes exclusion of relevant infectious diseases as established by the Chilean Ministry of Health.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sandra Montedónico, M.D.; Phone Number: +56 32 2364246; Email: sandramontedonico@gmail.com
• Study Contact Backup: Name: Felipe Martinez, M.D; M.Sc.; Phone Number: +56 9 99690952; Email: felipe.martinez@uv.cl

Study Locations

• Chile
  • Valparaiso, Chile, 2341131
    • Recruiting
    • Hospital Carlos Van Buren
    • Contact: Sandra Montedónico, M.D.; Phone Number: +56 32 2364246; Email: sandramontedonico@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amniotic Membrane Dressing; 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 Dressing; 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.; Procedure: Standard Wound Care; 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.
Active Comparator: Synthetic Dressing; 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.	Procedure: Standard Wound Care; 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.; Device: Synthetic Dressing; 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.; Other Names: Mepitel (R)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total Grafted Skin Area	Within the first 30 days after randomisation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Hospital Stay		Within the first 45 days after randomisation.
Surgical Debridement	Total number of surgical debridements required by participants until discharge.	Within the first 30 days after randomisation

Collaborators and Investigators

• Sponsor: Universidad de Valparaiso
• Collaborators: National Fund for Research and Development in Health, Chile; Hospital Carlos Van Buren
• Investigators: Study Director: sandramontedonico@gmail.com Montedonico, M.D., Servicio de Cirugía Pediátrica, Hospital Carlos Van Buren, Valparaíso, Chile; Principal Investigator: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Chilean Ministry of Health Guidelines on the Management of the Burn Patient

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: September 4, 2016
• First Submitted That Met QC Criteria: September 13, 2016
• First Posted (Estimate): September 19, 2016

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Children; Skin Transplantation; Amniotic Membrane
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: SA15I20099

Plan for Individual participant data (IPD)

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