Overview

This trial is active, not recruiting.

Condition burns
Treatments amniotic membrane dressing, synthetic dressing, standard wound care
Sponsor Universidad de Valparaiso
Collaborator Fondo Nacional de Investigación y Desarrollo en Salud (FONIS)
Start date September 2016
End date December 2017
Trial size 60 participants
Trial identifier NCT02904941, SA15I20099

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Children allocated to this arm will receive skin dressings made out of human amniotic membrane. Dressings will be replaced every 72 - 96 hours.
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.
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)
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.
synthetic dressing Mepitel (R)
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.
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.

Primary Outcomes

Measure
Total Grafted Skin Area
time frame: Within the first 30 days after randomisation

Secondary Outcomes

Measure
Length of Hospital Stay
time frame: Within the first 45 days after randomisation.
Surgical Debridement
time frame: Within the first 30 days after randomisation

Eligibility Criteria

Male or female participants up to 15 years old.

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.

Additional Information

Official title Human Amniotic Versus Synthetic Membrane as a Transient Skin Cover for Pediatric Burns: A Randomised Trial
Principal investigator Sebastián San Martín, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Universidad de Valparaiso.