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

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.

Conditions

• Burns

Interventions

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.

Sponsors & Collaborators

• National Fund for Research and Development in Health, Chile

  collaborator OTHER

• Hospital Carlos Van Buren

  collaborator OTHER

• Universidad de Valparaiso

  lead OTHER

Principal Investigators

• [email protected] Montedonico, M.D. · Servicio de Cirugía Pediátrica, Hospital Carlos Van Buren, Valparaíso, Chile

• Sebastián San Martín, Ph.D. · Escuela de Medicina, Universidad de Valparaíso, Chile

• Felipe Martínez, M.D. · Escuela de Medicina, Universidad de Valparaíso, Chile

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Max Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-30

Primary Completion

2022-12-31

Completion

2022-12-31

Countries

• Chile

Study Locations