[Trial of device that is not approved or cleared by the U.S. FDA]

This trial has been identified as being associated with a clinical device that has not been approved or cleared by the US Food and Drug Administration. Under the terms of US Public Law 110-85, Title VIII, Section 801, the details of this study are not available to the public.
Sponsor:
Information provided by:
[Redacted]
ClinicalTrials.gov Identifier:
NCT01138917
First received: June 3, 2010
Last updated: February 19, 2015
Last verified: NA

June 3, 2010
February 19, 2015
June 2010
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  • Recipient site wound closure for both ReCell and STMSG [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Recipient site wound closure for both ReCell and STMSG will be defined as the presence of >95% epithelialization with contiguous layer of viable epithelium without the need for secondary surgical intervention. The outcomes of the recipient site wound closure will be documented photographically using standardized digital photographic techniques and will be transferred to a Central Reading Facility to be reviewed by qualified Independent Clinical Experts. Avita Medical expects that the wound closure of the ReCell treated recipient sites will be no worse than that obtained using STMSG.
  • Superiority of the ReCell donor site healing as compared to STMSG donor site [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Donor site healing will be considered as complete (100%) wound closure, defined as the ability to separate the dressing from the wound bed and the visible presence over the entirety of the wound of dry, opalescent-pink external surface of the newly formed outer layer of the epidermis. The outcomes of wound closure will be documented using standardized photographic techniques and will be transferred to a Central Reading Facility to be reviewed by qualified Independent Clinical Experts. Avita Medical expects the wound closure of the ReCell donor sites will be superior to the STMSG donor site.
Complete list of historical versions of study NCT01138917 on ClinicalTrials.gov Archive Site
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  • Percent of epithelialization of the ReCell and STMSG treated areas [ Time Frame: all follow-up visits up to week 16 ] [ Designated as safety issue: No ]
    The percent epithelialization of the ReCell and STMSG treated areas will be assessed using standardized planimetry/tracing procedures and will be forwarded to the Central Reading Facility for calculation using a computerized measurement technique.
  • recipient site wound closure [ Time Frame: week 2 ] [ Designated as safety issue: No ]
    The recipient site wound closure at week 2 will be evaluated using Investigators assessment of wound healing
  • Pain and appearance at the ReCell and STMSG treatment areas and at donor sites [ Time Frame: all follow up visits up to week 16 ] [ Designated as safety issue: No ]
    Subject assessment of pain at the ReCell and STMSG treatment and donor sites will be performed at all study follow-up visits up to week 16. The subject assessments will be performed using VAS ( visual analogue scale) style questionnaires.
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[Trial of device that is not approved or cleared by the U.S. FDA]
[Trial of device that is not approved or cleared by the U.S. FDA]
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withheld
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Contact information is only displayed when the study is recruiting subjects
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United States,   Canada
 
NCT01138917
CTP001-5
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[Redacted]
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ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP