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:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 1:11 AM
NCT ID:
NCT02274493
Eligibility Criteria:
Inclusion Criteria:
1. The subject must be equal to or greater than 18 years of age.
2. The subject must be willing and able to provide informed consent.
3. The subject is willing and able to comply with the study protocol.
4. The subject is undergoing one of the following reconstructive procedures that requires latissimus dorsi muscle harvest: a. Post-mastectomy breast reconstruction procedure (either nipple or skin sparing) in which a female subject needs additional muscle coverage over an implant, but does not need additional skin (i.e., patient is a candidate for a pedicled latissimus dorsi muscle flap procedure); b. Scalp reconstruction procedure in which the subject needs a free latissimus dorsi muscle flap for wound coverage; c. Upper extremity reconstruction procedure in which the subject needs a free latissimus dorsi muscle flap for wound coverage; or, d. Lower extremity reconstruction procedure in which the subject needs a free latissimus dorsi muscle flap for wound coverage.
5. The subject agrees to follow-up examinations out to 6 months post-treatment.
Exclusion Criteria:
1. The subject has a BMI \> 35.
2. The subject has a history of significant bleeding disorders.
3. The subject is diabetic.
4. The subject is known or suspected to be pregnant or lactating.
5. The subject has a history of peripheral vascular disease.
6. The subject is a current smoker (has smoked within 4 weeks prior to surgery).
7. The subject has had prior back or axillary surgeries which could compromise the blood supply of the flap.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02274493
Study Brief:
Protocol Section:
NCT02274493