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

Universidad de Valparaiso

Status: Unknown

Conditions: Burns

Treatments: Device: Synthetic Dressing; Procedure: Standard Wound Care; Biological: Amniotic Membrane Dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT02904941

SA15I20099

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: Under 15 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

60 participants in 2 patient groups

Amniotic Membrane Dressing

Experimental group

Description:

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

Treatment:

Procedure: Standard Wound Care

Biological: Amniotic Membrane Dressing

Synthetic Dressing

Active Comparator group

Description:

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.

Treatment:

Procedure: Standard Wound Care

Device: Synthetic Dressing