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

Not Applicable

• Conditions: Burns
• Interventions: Biological: Amniotic Membrane Dressing; Device: Synthetic Dressing; Procedure: Standard Wound Care

• Registration Number: NCT02904941
• Lead Sponsor: Universidad de Valparaiso

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.

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 Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-04
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-19
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-04
• Last Update Posted: 2020-11-05
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amniotic Membrane Dressing	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.
Synthetic Dressing	Standard Wound Care	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.
Amniotic Membrane Dressing	Standard Wound Care	Children allocated to this arm will receive skin dressings made out of human amniotic membrane. Dressings will be replaced every 72 - 96 hours.
Synthetic Dressing	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.

Primary Outcome Measures

Name	Time	Method
Total Grafted Skin Area	Within the first 30 days after randomisation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Carlos Van Buren; 🇨🇱 Valparaiso, Chile