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 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT01791504
Eligibility Criteria:
Inclusion Criteria:
* Male or female, ≥ 18 years of age
* Provide signed and dated informed consent form
* Willing to comply with all study procedures, schedules and be available for the follow-up evaluations for the duration of the study
* Willing to follow instructions for incision and drain care, and follow guidelines related to resumption of daily activities
* Agree not to schedule any additional elective surgical procedures that involve an incision until their participation in the study is complete
* In good general health in the opinion of the Investigator with no conditions that would significantly impact wound healing as determined by medical history, and review of recent concomitant medications
* Requiring at least one full thickness surgical incision of at least 20cm in length as part of elective abdominoplasty
* ≤ ASA2 - American Society of Anesthesiologists Physical Classification System (2=subject with mild systemic disease)
* Have a Body Mass Index (BMI) ≤ 28
Exclusion Criteria:
* Pregnancy or lactation
* Previous abdominoplasty
* Prior bariatric or weight loss surgery
* Lost ≥ 15% of maximum lifetime bodyweight (excluding pregnancy weight gain)
* Known medical condition that results in compromised blood supply to tissues
* Have known or suspected allergy or sensitivity to any test materials or reagents
* Have severe co-morbid conditions (e.g., heart disease)
* Are currently a smoker or have smoked within 30 days of prescreening as determined by nicotine test
* Any condition known to effect wound healing, such as collagen vascular disease
* Be known to have a blood clotting disorder and/or be willing to discontinue anti-coagulation therapy including aspirin
* Diagnosis of diabetes with current medical treatment
* Receiving antibiotic therapy for pre-existing condition or infection
* Have known personal or family history of keloid formation or hypertrophic scarring
* Currently taking systemic steroids or immunosuppressive agents
* Undergoing concurrent adjacent or congruent Liposuction agents
* Use of pain pumps after the abdominoplasty procedure
* Concurrent use of fibrin sealants or other internal wound care devices
* Concurrent hernia repair greater than 6 cm and/or requiring the use of mesh
* Mini abdominoplasty (abdominoplasty without umbilical transposition)
* Be participating in any current clinical trial or have participated in any clinical trial within 30 days of enrollment in this study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01791504
Study Brief:
Protocol Section:
NCT01791504