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:
2025-12-26 @ 2:39 PM
Ignite Modification Date:
2025-12-26 @ 2:39 PM
NCT ID:
NCT02680106
Eligibility Criteria:
Inclusion Criteria:
* The patient is ≥ 18 years old at enrolment. Both genders.
* Patients with donor site wound, size of 10-200 cm2, located in the thigh after partial thickness skin-graft
* The patient is able and willing to comply with study procedures and give written informed consent prior to enrollment in the study
Exclusion Criteria:
* Any known or suspected systemic infection
* Any known sensitivity to components/products used in this study
* Use of penicillamine, corticosteroid or immunosuppressive medication within two months prior to enrollment, or current use of nonsteroidal anti- inflammatory agents which cannot be discontinued, or who is likely to be prescribed these medications or any other medications known to adversely affect wound healing during study participation
* Major uncontrolled systemic disorders such as hepatic, renal, neurologic, or endocrinologic disorders.
* Patients undergoing repeat skin graft harvesting at the same donor site
* Patients with burns of more than 15% TBSA
* Requires immersion hydrotherapy at any time during study participation
* Bleeding disorders
* Skin disorders such as psoriasis, pemphigus, Toxic Epidermal Necrolysis (TEN), Stevens-Johnson Syndrome (SJS), pyoderma gangrenosum and other exfoliative disorders
* Terminal patients
* Soldiers
* Prisoners
* Female patients who are pregnant or nursing, or of childbearing potential and are not using adequate contraception
* Participation in another clinical trial within 30 days prior to the Screening Visit or during this study.
* Psychiatric patient.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02680106
Study Brief:
Protocol Section:
NCT02680106