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 range18 Years
SexALL
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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.
What they're measuring
1
Rate of post-surgical local complications
Timeframe: 30 days
Trial details
NCT IDNCT04214236
SponsorAzienda Ospedaliera, Ospedale Civile di Legnano