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 @ 12:41 PM
Ignite Modification Date:
2025-12-24 @ 12:41 PM
NCT ID:
NCT00582361
Eligibility Criteria:
Inclusion Criteria:
* Patient who has sustained an open fracture that requires surgical irrigation and debridement.
* No gross clinical evidence of infection.
Exclusion Criteria:
* A grossly infected open wound. Infection will be defined by clinical signs and symptoms of infection that include increasing drainage, increasing pain, purulent drainage, and increasing erythema. Any wounds that are thought to be infected will be cultured to confirm the diagnosis.
* A surgical incision that can not be covered with VAC sponges and a water impermeable sheet (such as Ioban or Tegaderm) to achieve a closed vacuum environment over the wound.
* Wounds associated with the surgical incision that are intentionally left open to heal with either a delayed primary closure or secondary granulation
* Abnormal coagulation leading to an expanding hematoma that will require surgical debridement.
* Pregnant women.
* Inability or unwillingness to comply with protocol.
* Patients or family members who are unable or unwilling to sign study informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT00582361
Study Brief:
Protocol Section:
NCT00582361