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 @ 7:48 PM
Ignite Modification Date:
2025-12-24 @ 7:48 PM
NCT ID:
NCT00633503
Eligibility Criteria:
Inclusion Criteria:
* Adult patients planned to undergo reconstructive surgery using either a pedicle or free tissue transfer flap seen by The Plastic Surgery Service on either an in-patient or outpatient bases.
* Adult patients that are planned to undergo reconstructive surgery as above and able to receive information regarding the study and provide informed consent to enrollment in the study.
Exclusion Criteria
* All emergency reconstructive surgery patients.
* Patients planned to undergo radiation therapy in the region of the reconstructive surgery within 6 months after surgery.
* Patients who develop hypotension requiring the administration of vasopressors either intra-operatively or during the post-operative period prior to discharge from the hospital.
* Patients who develop clinical signs of a surgical site infection at the location of the tissue transfer flap(s).
* Patients with the development of post-operative anemia requiring a blood transfusion during the first 72 hours after surgery.
* Patients with tattooing or pigmented lesions on the tissue transfer flap.
* Patients who incur injury to the flaps secondary to trauma within 6 months of the reconstructive surgery; with trauma defined as either accidental major trauma resulting in injury to the tissue transfer flap or surgical trauma as a result of further oncologic resection of tissues in close proximity to the tissue transfer flap.
* Minor under the age of 18 years of age.
* Patients deemed unable to comprehend and provide informed consent to enrollment into study due to either a cognitive deficit or medical condition.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00633503
Study Brief:
Protocol Section:
NCT00633503