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

Burns Clinical Trial

Official title:

Human Amniotic Versus Synthetic Membrane as a Transient Skin Cover for Pediatric Burns: A Randomised Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02904941
• Other study ID #: SA15I20099
• Status: Recruiting
• Phase: N/A
• Start date: September 2016
• Est. completion date: December 2022

Study information

• Verified date: November 2020
• Source: Universidad de Valparaiso
• Contact: Sandra Montedonico, M.D.
• Phone: 2364246
• Email: sandramontedonico[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burns

Intervention

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.

Locations

Country	Name	City	State
Chile	Hospital Carlos Van Buren	Valparaiso

Sponsors (3)

Lead Sponsor	Collaborator
Universidad de Valparaiso	Hospital Carlos Van Buren, National Fund for Research and Development in Health, Chile

Country where clinical trial is conducted

Chile, 

References & Publications (5)

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. — View 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. Review. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Grafted Skin Area		Within the first 30 days after randomisation
Secondary	Length of Hospital Stay		Within the first 45 days after randomisation.
Secondary	Surgical Debridement	Total number of surgical debridements required by participants until discharge.	Within the first 30 days after randomisation

External Links

•   Chilean Ministry of Health Guidelines on the Management of the Burn Patient