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 @ 5:14 PM
Ignite Modification Date:
2025-12-24 @ 5:14 PM
NCT ID:
NCT01807650
Eligibility Criteria:
Inclusion Criteria:
* Participants at least 18 years old who have provided written informed consent
* Presenting a split-thickness skin graft donor site wound with a minimum size of 15 cm2 and with a minimum width of 3 cm.
* Participant was able to understand the Informed Consent Form (ICF) provided and was prepared to comply with all study requirements, including the following: Visiting the trial site for wound dressing change and photo documentation every third or fourth day until both wound halves were closed (but no longer than 28 days after surgery).
* Willing to perform all necessary wound dressing changes at the trial site. Also the participant needed to agree to return to site for 3 and 12 months follow-up visits.
* Women of childbearing potential who were in the period between menarche and menopause needed to apply a highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly (e.g., implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices \[IUDs\], sexual abstinence, or a vasectomized partner). Birth control method needed to have been applied for at least 1 monthly cycle prior to first administration of study drug, be maintained during the study treatment phase and continued for at least 30 days after the last administration of study drug. Sexually active, non-vasectomized men needed to use a barrier method (condoms) during the treatment phase of this clinical trial.
Exclusion Criteria:
* Diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety or efficacy.
* A skin disorder that was chronic or currently active and which the Investigator considered would adversely affect the healing of the acute wounds or involved the areas to be examined in this trial.
* A history of clinically significant hypersensitivity to any of the drugs, surgical dressings or excipients to be used in this trial.
* Known multiple allergic disorders.
* Taking, or have taken, any investigational drugs within 3 months prior to the screening visit.
* Pregnant or breast feeding women were not allowed to participate in the study.
* Inappropriate to participate in the study, for any reason, in the opinion of the investigator.
* Mental incapacity or language barriers precluding adequate understanding the ICF or co-operation or willingness to follow study procedures.
* Previous participation in this study.
* Employee at the investigational site, relative or spouse of the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01807650
Study Brief:
Protocol Section:
NCT01807650