Performance, Safety and Efficacy of NPWT Device (NCT04102865) | Clinical Trial Compass
CompletedNot Applicable
Performance, Safety and Efficacy of NPWT Device
United Kingdom90 participantsStarted 2019-07-12
Plain-language summary
Smith \& Nephew are assessing a new investigational single use NPWT system.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The subject must provide written informed consent.
* Subjects eighteen (18) years of age or older.
* Willing and able to make all required study visits.
* Able to follow instructions.
* Subject is suitable to participate in the study in the opinion of the Investigator
* In Orthopaedic surgery: subject is scheduled for an elective primary knee replacement arthroplasty and American Society of Anesthesiologists (ASA) score of 2-3 (Phase 1 only)
* In Abdominal surgery: subject is scheduled for an elective open or laparoscopic gastrointestinal and/or gynaecological surgery with incision ≥5 cm and has an ASA score of 2-3.
* Immediately after the surgery, subject will have one suitable closed abdominal or knee surgery incision (if there is more than one incision, then the clinician should choose the one which, in their opinion, is most suited for Negative Pressure Wound Therapy) that fits under the absorbent dressing area of the appropriate Negative Pressure dressing sizes .
Exclusion Criteria:
* Contraindications (per the Investigator Brochure) or hypersensitivity to the use of the investigational product or their components (e.g. silicone adhesives and polyurethane films \[direct contact with incision\], acrylic adhesives \[direct contact with skin\], polyethylene fabrics and super-absorbent powders \[polyacrylates\]) within the dressing).
* Subjects with extremely fragile skin who require the use of SECURA™ non-sting barrier skin wipes and have hypersensi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.