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 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT04894604
Eligibility Criteria:
Inclusion criteria:
1. Male or female ≥ 18 years of age.
2. Signed written Informed Consent Form.
3. Low to moderate exuding surgically closed incisions suitable for suNPWT, according with the Investigator´s judgement and the Avance® Solo NPWT System Instructions for Use.
4. Study subjects that are deemed capable and willing to comply with the protocol instructions.
Exclusion criteria:
1. Known malignancy in the wound or margins of the wound.
2. Untreated and previously confirmed osteomyelitis.
3. Non-enteric and unexplored fistulas.
4. Necrotic tissue with eschar present.
5. Exposed nerves, arteries, veins or organs.
6. Exposed anastomotic site.
7. Known allergy/hypersensitivity to the dressing or its components.
8. Known pregnancy or planning to become pregnant or breastfeeding at time of study participation.
9. Participation in another investigative drug or device trial currently or within the last 30 days.
10. Subjects not suitable for the investigation according to the Investigator's judgement, Clinical Investigation Plan and Instructions for Use.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04894604
Study Brief:
Protocol Section:
NCT04894604