- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04214236
CiNPT for Abdominoplasties in Post-bariatric Patients Study (CAPS)
Evaluation of ciNPT Effects on Healing and Post-surgical Complications in High-risk Post- Bariatric Patients Undergoing Body-contouring Abdominoplasty: a Monocentric Prospective RCT
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.
Study Overview
Status
Conditions
- Obesity
- Obesity, Morbid
- Surgery--Complications
- Surgical Wound Infection
- Surgical Site Infection
- Wound Infection
- Scar
- Wound Heal
- Obesity, Abdominal
- Wound
- Wound Contamination
- Wound Complication
- Scarring
- Wound Dehiscence
- Incision
- Wound; Abdomen
- Incision Site Rash
- Incision Site Bleeding
- Incision Site Swelling
- Incision Site Haematoma
- Incision Site Infection
- Incision Site Inflammation
- Incision Site Complication
- Incision Surgical
- Scarring as Surgical Complication
Intervention / Treatment
Detailed Description
In the United States (US) 37% of the adult population is obese and 5% is considered morbidly obese. Similar trends have been observed in Europe and more recently in Asia. A large number of obese patients seeks treatment through bariatric surgery or diet-lifestyle changes. The resulting massive loss of weight leaves patients with an excess cutaneous tissue, requiring body-contouring procedures.
In the US 85% of post-bariatric patients seek body-contouring surgeries. Due to systemic and local factors, these procedures show a rate of local complications as high as 68-80%, significantly prolonging hospitalization and increasing treatment-related costs.
Several clinical studies have shown that external suction (Closed Incision Negative-Pressure Therapy, ciNPT) can accelerate closure of surgical wounds in patients at high-risk for impaired/delayed healing and can significantly reduce the rate of local complications. The investigators believe that ciNPT might significantly decrease the rate of minor local complications in post-bariatric patients undergoing body-contouring procedures, and that this strategy could represent a cost-effective adjuvant treatment in body-contouring procedures.
The investigators' preliminary study experience on post-bariatric obese patients undergoing an abdominoplasty and post-operatively treated with ciNPT, showed that ciNPT promotes effective and prompt wound closure minimizing peri-operative/post-operative complications in these patients. The investigators also showed that ciPNT positively impacts the length of hospitalization and the rate of secondary surgeries in these patients.
Based on this successful preliminary experience, the invetsigators here propose to validate these findings in a prospective RCT.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Silvio Abatangelo, M.D.
- Phone Number: +39 (02) 97 96 3466
- Email: caps.trial@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ciNPT group
Subjects will receive post-operative incisional wound care by ciNPT (125 mmHg, continuous suction) for the first 7 days after surgery.
|
Closed-incision negative pressure therapy (ciNPT) will be applied for 7 day using continuous suction at 125 mmHg.
To deliver ciNPT we will use a commercially available, FDA-approved device, used according to the manufacturer' indications (PREVENA™ Incision Management System (KCI, San Antonio, Texas, USA).
After the first 7 post-operative days, subjects will discontinue the ciNPT and follow a standard wound care protocol.
Other Names:
|
Sham Comparator: Control group
Subjects will receive post-operative incisional wound care by standard non-adherent surgical dressing (vaseline petrolatum gauze),
|
Standard non-adherent surgical dressing (Vaseline petrolatum gauze) will be used for management of incisional wounds in the control group.
Dressing changes will be performed per standard wound care protocol.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of post-surgical local complications
Time Frame: 30 days
|
The change in post-surgical local complications (Skin blistering/necrosis, Surgical Site Infections, hematoma, seroma, need for re-operation) through 30 days after surgery.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time-to-heal
Time Frame: <60 days
|
A change in time (days) to complete wound closure for treated groups vs. controls.
|
<60 days
|
Scar quality: Vancouver Scar Scale
Time Frame: 30 and 90 days
|
A change in the macroscopic quality of scars at a 30 and 90 days follow up (measured with the Vancouver Scar Scale-VSS [Score range: 0-13, lower scores being a better outcome]).
|
30 and 90 days
|
Medical costs
Time Frame: 60 days
|
A change in direct medical costs (considering cumulative costs related to: hospitalization, standard and additional post-operative care, additional surgical and medical care for complications) in the first 60 days after surgery.
|
60 days
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Silvio Abatangelo, M.D., ASST Ovest Milanese
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Disease Attributes
- Hemorrhage
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Fibrosis
- Obesity
- Inflammation
- Infections
- Communicable Diseases
- Wounds and Injuries
- Obesity, Morbid
- Surgical Wound
- Surgical Wound Infection
- Cicatrix
- Wound Infection
- Obesity, Abdominal
- Hematoma
Other Study ID Numbers
- CAPS/01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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