Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT01033604
Eligibility Criteria:
Inclusion Criteria:
* All burn wounds with flux values measured by Laser Doppler Imaging, corresponding with an expected healing time longer than 28 days. Dark blue color on the palette of the LDI software with flux values below 200
* All clearly full thickness burns on clinical assessment done by two plastic surgeons and thereafter treated with Flammacerium®.
* Wounds treated with a hydrocolloid paste prior to LDI and with low flux values \< 200
* All assessments are done during first days before final decision at day three
* Possibility to follow the complete treatment schedule until final graft take and subsequently wound healing and finally participation on complete follow-up schedule
* Informed consent has been obtained
* TBSA Full Thickness Burn \< 40%
Exclusion Criteria:
* All burn wounds with flux values measured by Laser Doppler Imaging, corresponding with faster healing times ( flux values \>200 )
* TBSA \>40 %
* Not following the complete treatment schedule or missing some evaluations during the follow-up period
* Patient has any condition(s) that seriously compromises the patient's ability to complete this study.
* Patient has participated in another study utilizing an investigational drug within the previous 30 days
* Patient has one or more medical condition(s), diabetes, including renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the investigator would make the patient an inappropriate candidate for this study
* Patients wish to decline from the study
* No informed consent before start of the trial
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
80 Years
Study:
NCT01033604
Study Brief:
Protocol Section:
NCT01033604