Evaluation of Safety of Xeno-Skin™ for Treatment of Severe and Extensive, Partial and Full Thickness 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: NCT03695939|
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : January 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Burn Wound||Biological: Xeno-Skin™||Phase 1|
This Phase 1 Study is a 2 cohort, open-label, non-randomized trial, to assess the safety and tolerability of Xeno-Skin™ for the treatment of severe and extensive, deep partial and full thickness burn wounds as a first-line treatment, and temporary coverage prior to definitive wound closure.
Subjects who meet eligibility criteria and provide informed consent will receive placement of Xeno-Skin™ on a single burn wound site.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Phase 1 Study to Evaluate the Safety and Tolerability of Xeno-Skin™ for Temporary Coverage of Severe and Extensive, Deep Partial and Full Thickness Burn Wounds|
|Actual Study Start Date :||March 15, 2019|
|Estimated Primary Completion Date :||April 15, 2020|
|Estimated Study Completion Date :||July 15, 2020|
Single arm trial
3+3 Dose-escalation Study Design; 2 dosage strengths will be utilized during this Phase 1 Trial
- Safety and Tolerability: Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 6 months ]Number of Participants with Adverse Events as a Measure of Safety and Tolerability
- Clinically Relevant Response [ Time Frame: daily through 4 weeks, 6 months ]To assess the quality and duration of temporary barrier function afforded by Xeno-Skin™(as determined by the Clinical Wound Assessment Scale, adapted from Branski et al 2011). Six characteristics are assessed: Graft dislocation; Graft adherence, Granulation tissue; Hyper-granulation; Hematoma; and Fibrin deposit. Each characteristic is assessed on an independent 0-5 scale and subscale scores are reported. It is expected that some characteristics may not be assessible at all stages of the grafting process and NA may be recorded.
- Time of Graft Adherence. [ Time Frame: daily through 4 weeks ]To assess the duration of temporary barrier function afforded by Xeno-Skin™
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): NCT03695939
|Contact: Paul Holzer||(617) firstname.lastname@example.org|
|Contact: Krysta Moulton||(617) email@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Jeremy Goverman, MD 617-726-3712|
|Principal Investigator:||Jeremy Goverman, MD||Massachusetts General Hospital|