drugset / Trial / NCT02904941
Human Amniotic Versus Synthetic Membrane as a Transient Skin Cover for Pediatric Burns
Unknown
60 enrolled
Universidad de Valparaiso
Hospital Carlos Van Buren · collabNational Fund for Research and Development in Health, Chile · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2016-09
- Primary completion
- 2022-12
- Completion
- 2022-12
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amniotic Membrane Dressing | Unknown | — | Topical |
Indications
No indication recorded.