CiNPT for Abdominoplasties in Post-bariatric Patients Study

NCT ID: NCT04214236

Last Updated: 2020-01-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2023-01-31

Brief 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.

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; Wound Dehiscence; Wound Contamination; Wound Heal; Wound; Abdomen; Incision; Incision Site Rash; Incision Site Bleeding; Incision Site Swelling; Incision Site Haematoma; Incision Site Infection; Incision Site Inflammation; Incision Site Complication; Incision Surgical; Surgery--Complications; Surgical Wound Infection; Surgical Site Infection; Scarring as Surgical Complication; Scar; Scarring

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

ciNPT group

Subjects will receive post-operative incisional wound care by ciNPT (125 mmHg, continuous suction) for the first 7 days after surgery.

Group Type: EXPERIMENTAL

ciNPT group

Intervention Type: DEVICE

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 group

Subjects will receive post-operative incisional wound care by standard non-adherent surgical dressing (vaseline petrolatum gauze),

Group Type: SHAM_COMPARATOR

Control group

Intervention Type: OTHER

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.

Interventions

ciNPT group

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.

Intervention Type: DEVICE

Control group

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.

Intervention Type: OTHER

Other Intervention Names

ciNPT; PREVENA™ Incision Management System; closed-incision negative pressure therapy; Standard incisional wound care

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Acelity

OTHER

Sponsor Role: collaborator

Azienda Ospedaliera, Ospedale Civile di Legnano

OTHER

Sponsor Role: lead

Responsible Party

Silvio Abatangelo

Plastic Surgeon - Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Silvio Abatangelo, M.D.

Role: PRINCIPAL_INVESTIGATOR

ASST Ovest Milanese

Central Contacts

Silvio Abatangelo, M.D.

Role: CONTACT

caps.trial@gmail.com

+39 (02) 97 96 3466

References

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.

Reference Type: RESULT

PMID: 29730777 (View on PubMed)

Other Identifiers

CAPS/01

Identifier Type: -

Identifier Source: org_study_id