Clinical trial NCT02904941: Human Amniotic Versus Synthetic Membrane as a Transient Skin Cover for Pediatric Burns
Official title: Human Amniotic Versus Synthetic Membrane as a Transient Skin Cover for Pediatric Burns: A Randomised Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burns
Keywords: Children
Skin Transplantation
Amniotic Membrane
Lead sponsor: Universidad de Valparaiso
Sponsor class: OTHER
Collaborators: name: National Fund for Research and Development in Health, Chile
name: Hospital Carlos Van Buren
First posted: 2016-09-19
Enrollment: 60
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total Grafted Skin Area
timeFrame: Within the first 30 days after randomisation
Secondary outcomes:
measure: Length of Hospital Stay
timeFrame: Within the first 45 days after randomisation.
measure: Surgical Debridement
timeFrame: Within the first 30 days after randomisation
Other outcomes:
Locations:
city: Valparaiso
country: Chile
facility: Hospital Carlos Van Buren
Study officials:
affiliation: Servicio de Cirugía Pediátrica, Hospital Carlos Van Buren, Valparaíso, Chile
name: sandramontedonico@gmail.com Montedonico, M.D.
role: STUDY_DIRECTOR
affiliation: Escuela de Medicina, Universidad de Valparaíso, Chile
name: Sebastián San Martín, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Escuela de Medicina, Universidad de Valparaíso, Chile
name: Felipe Martínez, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Selig HF, Lumenta DB, Giretzlehner M, Jeschke MG, Upton D, Kamolz LP. The properties of an "ideal" burn wound dressing--what do we need in daily clinical practice? Results of a worldwide online survey among burn care specialists. Burns. 2012 Nov;38(7):960-6. doi: 10.1016/j.burns.2012.04.007. Epub 2012 May 8.
citation: Fairbairn NG, Randolph MA, Redmond RW. The clinical applications of human amnion in plastic surgery. J Plast Reconstr Aesthet Surg. 2014 May;67(5):662-75. doi: 10.1016/j.bjps.2014.01.031. Epub 2014 Jan 31.
citation: Fraser JF, Cuttle L, Kempf M, Phillips GE, Hayes MT, Kimble RM. A randomised controlled trial of amniotic membrane in the treatment of a standardised burn injury in the merino lamb. Burns. 2009 Nov;35(7):998-1003. doi: 10.1016/j.burns.2009.01.003. Epub 2009 May 17.
citation: Bilic G, Zeisberger SM, Mallik AS, Zimmermann R, Zisch AH. Comparative characterization of cultured human term amnion epithelial and mesenchymal stromal cells for application in cell therapy. Cell Transplant. 2008;17(8):955-68. doi: 10.3727/096368908786576507.
citation: Vloemans AF, Hermans MH, van der Wal MB, Liebregts J, Middelkoop E. Optimal treatment of partial thickness burns in children: a systematic review. Burns. 2014 Mar;40(2):177-90. doi: 10.1016/j.burns.2013.09.016. Epub 2013 Nov 26.