NCT02904941

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Universidad de Valparaiso · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Burns

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2016-09-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2016-09-19
• Last updated: 2020-11-05

Locations

1 site across 1 country: Chile