ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02904941
Recruitment Status : Recruiting
First Posted : September 19, 2016
Last Update Posted : December 15, 2017
Sponsor:
Collaborators:
Fondo Nacional de Investigación y Desarrollo en Salud (FONIS)
Hospital Carlos Van Buren de Valparaíso, Chile
Information provided by (Responsible Party):
Universidad de Valparaiso

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.

Condition or disease Intervention/treatment Phase
Burns Biological: Amniotic Membrane Dressing Device: Synthetic Dressing Procedure: Standard Wound Care Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Human Amniotic Versus Synthetic Membrane as a Transient Skin Cover for Pediatric Burns: A Randomised Trial
Study Start Date : September 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
Experimental: Amniotic Membrane Dressing
Children allocated to this arm will receive skin dressings made out of human amniotic membrane. Dressings will be replaced every 72 - 96 hours.
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.

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.

Active Comparator: Synthetic Dressing
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.
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.
Other Name: Mepitel (R)

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.




Primary Outcome Measures :
  1. Total Grafted Skin Area [ Time Frame: Within the first 30 days after randomisation ]

Secondary Outcome Measures :
  1. Length of Hospital Stay [ Time Frame: Within the first 45 days after randomisation. ]
  2. Surgical Debridement [ Time Frame: Within the first 30 days after randomisation ]
    Total number of surgical debridements required by participants until discharge.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02904941


Contacts
Contact: Sandra Montedonico, M.D. 2364246 ext +56 32 sandramontedonico@gmail.com
Contact: Felipe Martinez, M.D; M.Sc. 99690952 ext +56 9 felipe.martinez@uv.cl

Locations
Chile
Hospital Carlos Van Buren Recruiting
Valparaiso, Chile, 2341131
Contact: Sandra Montedónico, M.D.    2364246 ext +56 32    sandramontedonico@gmail.com   
Sponsors and Collaborators
Universidad de Valparaiso
Fondo Nacional de Investigación y Desarrollo en Salud (FONIS)
Hospital Carlos Van Buren de Valparaíso, Chile
Investigators
Study Director: sandramontedonico@gmail.com Montedonico, M.D. Servicio de Cirugía Pediátrica, Hospital Carlos Van Buren, Valparaíso, Chile
Principal Investigator: Sebastián San Martín, Ph.D. Escuela de Medicina, Universidad de Valparaíso, Chile
Principal Investigator: Felipe Martínez, M.D. Escuela de Medicina, Universidad de Valparaíso, Chile

Additional Information:
Publications:
Responsible Party: Universidad de Valparaiso
ClinicalTrials.gov Identifier: NCT02904941     History of Changes
Other Study ID Numbers: SA15I20099
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Universidad de Valparaiso:
Children
Skin Transplantation
Amniotic Membrane

Additional relevant MeSH terms:
Burns
Wounds and Injuries