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 @ 2:23 AM
Ignite Modification Date:
2025-12-25 @ 2:23 AM
NCT ID:
NCT01417234
Eligibility Criteria:
Inclusion Criteria:
* Trauma wound, pressure ulcer, post operative wound, colostomy take-down site, or other acute wound deemed appropriate by study investigator(s) as the source of the wound on any part of the body including head and neck, torso, and extremities
* Wound \< 16 cm in greatest diameter
* Subject ≥ 18 years of age
* Exudate \< 25 ml/ day (estimate)
* Female subjects of child-bearing potential must be willing to take a urine pregnancy test prior to starting study
* Subject is willing and able to sign informed consent
Exclusion Criteria:
* Wound \> 45 days old
* Wound-related cellulitis
* Wound located in an area not amenable to forming an air-tight seal
* Subject has untreated osteomyelitis
* Subject is allergic to wound care products
* Wound has exposed blood vessels not suitable for negative pressure therapy
* Subject is pregnant
* Subject is actively participating in other clinical trials that conflict with current study
* Subject has fistulas
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01417234
Study Brief:
Protocol Section:
NCT01417234