Obesity, MorbidCAPSNCT04214236
CiNPT for Abdominoplasties in Post-bariatric Patients Study
A study testing ciNPT group in people with Obesity, Morbid and Obesity, run by Azienda Ospedaliera, Ospedale Civile di Legnano.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid, Obesity, Obesity, Abdominal
- What is being tested?
- ciNPT group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2020to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Morbid, Obesity, Obesity, Abdominal, Wound, Wound Infection, Wound Complication
- Being tested
- ciNPT group, Control group
- Keywords
- Closed-incision negative pressure therapy, Negative pressure wound therapy, Wound care, Surgical incision, Wound complication, Dehiscence, Surgical Site Infection, Seroma, Hematoma, Wound Healing, Inflammation, Incisional Wound, Abdominoplasty, Abdominal panniculectomy, Body contouring
- Medical subject headings
- Obesity, Morbid, Obesity, Obesity, Abdominal, Wounds and Injuries, Wound Infection, Abdominal Injuries, Surgical Wound, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciNPT groupDevice
Also called ciNPT, PREVENA™ Incision Management System, closed-incision negative pressure therapy
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.
Control groupOther
Also called Standard incisional wound care
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.
| Study group | Role | What they receive |
|---|---|---|
| ciNPT group | Experimental | Subjects will receive post-operative incisional wound care by ciNPT (125 mmHg, continuous suction) for the first 7 days after surgery. Receives: Device: ciNPT group |
| Control group | Sham comparator | Subjects will receive post-operative incisional wound care by standard non-adherent surgical dressing (vaseline petrolatum gauze), Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of post-surgical local complications
The change in post-surgical local complications (Skin blistering/necrosis, Surgical Site Infections, hematoma, seroma, need for re-operation) through 30 days after surgery.
Measured: 30 days
Secondary outcomes (3)
Time-to-heal
A change in time (days) to complete wound closure for treated groups vs. controls.
Measured: <60 days
Scar quality: Vancouver Scar Scale
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]).
Measured: 30 and 90 days
Medical costs
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.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start1 Feb 2020 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Case-control Experimental/Interventional Group: post-operative ciNPT (first 7 days) Control Group: post-operative standard wound care
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera, Ospedale Civile di Legnano
- Sponsor type
- University, hospital or other
- Collaborators
- Acelity
- Responsible party
- Principal investigator, Silvio Abatangelo, Azienda Ospedaliera, Ospedale Civile di Legnano
- Investigators
- Silvio Abatangelo, M.D., Principal investigator, ASST Ovest Milanese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214236
- Sponsor's protocol ID
- CAPS/01
- Acronym
- CAPS
- Status last verified
- Dec 2019
- First submitted
- 20 Dec 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD will not be shared.
Publications
Abatangelo S, Saporiti E, Giatsidis G. Closed Incision Negative-Pressure Therapy (ciNPT) Reduces Minor Local Complications in Post-bariatric Abdominoplasty Body Contouring: a Retrospective Case-Control Series. Obes Surg. 2018 Jul;28(7):2096-2104. doi: 10.1007/s11695-018-3279-8.
PubMed 29730777
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of ciNPT Effects on Healing and Post-surgical Complications in High-risk Post- Bariatric Patients Undergoing Body-contouring Abdominoplasty: a Monocentric Prospective RCT
- ClinicalTrials.gov ID
- NCT04214236
- Acronym / sponsor ID
- CAPS / CAPS/01
- Conditions
- Obesity, Morbid, Obesity, Obesity, Abdominal, Wound, Wound Infection, Wound Complication
- Keywords
- Closed-incision negative pressure therapy, Negative pressure wound therapy, Wound care, Surgical incision, Wound complication, Dehiscence, Surgical Site Infection, Seroma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera, Ospedale Civile di LegnanoUniversity, hospital or other
- Collaborators
- Acelity
- Study start
- 1 Feb 2020 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Case-control Experimental/Interventional Group: post-operative ciNPT (first 7 days) Control Group: post-operative standard wound care
| Arm | Type | Receives |
|---|---|---|
| ciNPT group | Experimental | Device: ciNPT groupSubjects will receive post-operative incisional wound care by ciNPT (125 mmHg, continuous suction) for the first 7 days after surgery. |
| Control group | Sham comparator | Other: Control groupSubjects will receive post-operative incisional wound care by standard non-adherent surgical dressing (vaseline petrolatum gauze), |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ciNPT groupAlso: ciNPT, PREVENA™ Incision Management System, closed-incision negative pressure therapyClosed-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. | Device | ciNPT group |
| Control groupAlso: Standard incisional wound careStandard 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 | Control group |
Primary outcome
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.
3 secondary outcomes
Time-to-heal
Time frame: <60 days
Scar quality: Vancouver Scar Scale
Time frame: 30 and 90 days
Medical costs
Time frame: 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Results publication: PubMed 29730777Abatangelo S, Saporiti E, Giatsidis G. Closed Incision Negative-Pressure Therapy (ciNPT) Reduces Minor Local Complications in Post-bariatric Abdominoplasty Body Contouring: a Retrospective Case-Control Series. Obes Surg. 2018 Jul;28(7):2096-2104. doi: 10.1007/s11695-018-3279-8.
- Individual participant dataSharing planned: No. IPD will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvio Abatangelo, M.D. principal investigator
ASST Ovest Milanese
Questions about this trial
What is this clinical trial studying?
A study testing ciNPT group in people with Obesity, Morbid and Obesity, run by Azienda Ospedaliera, Ospedale Civile di Legnano.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvio Abatangelo, M.D. (+39 (02) 97 96 3466, caps.trial@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of post-surgical local complications (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04214236, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.