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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07398534
Eligibility Criteria:
Inclusion Criteria:
* \- Age ≥ 18 years
* Able to consent
* Patient of orthopaedic surgery or of the (Diabetic) Foot Polyclinic at the Balgrist University Hospital
* Presence of an acute, dehiscent, clinically uninfected wound requiring additional measures
* First episode of wound treatment for the actual wound (no recurrences) in the last 12 months
* Wound measuring ≥ 0.5 cm in wide, length or depth
* 42 days of scheduled follow-up
* Bacterial orthopaedic infections of any nature, independently of implants or co-morbidities; according to clinical, laboratory, radiological, microbiological features of infection
* First or second episode of infection
Exclusion Criteria:
* \- Patient's individual refusal to participate
* Patient already treated with any vacuum-assisted wound device for any wound in the last 12 months; independently of therapy success, the hospital or the localization of the prior wound
* Underlying liquor leak (spine surgery)
* Visually active bleeding from the wound
* Wound size \>10 cm in any dimension
* Anticipated active clinical follow-up of less than 42 days
* Other wound treatments besides PICO and debridement (e.g. hyperbaric oxygen therapy, other negative-pressure devices, local antibiotics, local antibiotic dressings) (however, local antiseptics and dressing changes remain allowed)
* Immediate surgical wound revision in the operating theatre for closure
* Planned plastic or reconstructive surgery already at inclusion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT07398534
Study Brief:
Protocol Section:
NCT07398534