CiNPT for Abdominoplasties in Post-bariatric Patients Study (NCT04214236) | Clinical Trial Compass
UnknownNot Applicable
CiNPT for Abdominoplasties in Post-bariatric Patients Study
130 participantsStarted 2020-02-01
Plain-language summary
The overarching goal of this research is to assess whether the post-operative use of closed-incision Negative Pressure Therapy (ciNPT) accelerates healing of surgical wounds, improves surgical outcomes, and reduces the rate of local complications in high-risk, obese, post-bariatric patients undergoing abdominal body-contouring procedures (abdominal panniculectomy or "abdominoplasty") compared to standard wound care.
The investigators postulate that ciNPT can cost-effectively improve outcomes and standard of post-surgical care in this specific category of patients.
This hypothesis will be tested through a prospective, interventional, case-control, randomized clinical trial.
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:
* previous bariatric surgery for weight loss
* candidate for/undergoing an abdominal panniculectomy (abdominoplasty)
* Residual BMI \>30 kg/m2 at the time of the operation
* Evidence of pannus (abdominal) ptosis (Pittsburgh Rating Scale \>2)
* Lipodystrophy and inelasticity of the skin
* Presence at the time of surgery of at least one local risk factor (e.g. a history or the presence of local complications such as skin blistering, recurrent erythema, panniculitis, or chronic infection; history of abdominal hernia or need for abdominal hernia repair) OR one systemic risk factor (diabetes, smoking habit, serum proteins below 6g/dL).
Exclusion Criteria:
* Severe systemic co-morbidities (defined as ASA III or higher)
* Malignant tumors
* Conditions or medications affecting wound healing (e.g. steroidal drugs or keloids)
* Known allergies to components of the treatment
* Presence of severe local cutaneous complications (open wounds, extensive infections) at the time of surgery.
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.
What they're measuring
1
Rate of post-surgical local complications
Timeframe: 30 days
Trial details
NCT IDNCT04214236
SponsorAzienda Ospedaliera, Ospedale Civile di Legnano