Clinical trial NCT04214236: CiNPT for Abdominoplasties in Post-bariatric Patients 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
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
Lead sponsor: Azienda Ospedaliera, Ospedale Civile di Legnano
Sponsor class: OTHER
Collaborators: name: Acelity
First posted: 2020-01-02
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Case-control Experimental/Interventional Group: post-operative ciNPT (first 7 days) Control Group: post-operative standard wound care
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Rate of post-surgical local complications
timeFrame: 30 days
Secondary outcomes:
measure: Time-to-heal
timeFrame: <60 days
measure: Scar quality: Vancouver Scar Scale
timeFrame: 30 and 90 days
measure: Medical costs
timeFrame: 60 days
Other outcomes:
Locations:
Study officials:
affiliation: ASST Ovest Milanese
name: Silvio Abatangelo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.