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 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
NCT ID:
NCT04488666
Eligibility Criteria:
Inclusion Criteria:
1\. Participant is male or female ≥ 18 years of age 2. Participant will undergo an elective sternotomy, thoracotomy, caesarean section (C-section) or skin surgery incision with closure by sutures or staples 3. Participant will undergo a surgical procedure resulting in a closed approximately linear incision between 5 cm and 13 cm in length inclusive so that the npSIMS dressing covers the wound with a minimum of 1 cm overlap at each end 4. Participant is willing and able to take part in the study and provide written informed consent.
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Exclusion Criteria:
1. Participants will undergo post-surgical radiotherapy or chemotherapy
2. Participants who, in the opinion of the Investigator, have an existing health condition that would compromise their participation and follow-up in this study
3. Participant will undergo emergency surgery
4. Participant is sensitive to or known to have allergies to silicone/acrylic adhesives
5. Participant has malignancy in the wound bed or margins of the wound
6. Participant has wound with confirmed and untreated osteomyelitis
7. Participant has wound with non-enteric and unexplored fistulas
8. Participant has wound with necrotic tissue with eschar present
9. Participant has exposed arteries, veins, nerves or organs
10. Participant has exposed anastomotic sites
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04488666
Study Brief:
Protocol Section:
NCT04488666