CiNPT for Abdominoplasties in Post-bariatric Patients Study

NCT04214236 | Unknown FDA Device

• 1 other identifier: CAPS/01
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days

Secondary Outcomes (3)

• Time-to-heal

  <60 days

• Scar quality: Vancouver Scar Scale

  30 and 90 days

• Medical costs

  60 days

Study Arms (2)

ciNPT group

EXPERIMENTAL

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

Device: ciNPT group

Control group

SHAM COMPARATOR

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

Other: Control group

Interventions

ciNPT group 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.

Also known as: ciNPT, PREVENA™ Incision Management System, closed-incision negative pressure therapy

ciNPT group

Control group 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.

Also known as: Standard incisional wound care

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera, Ospedale Civile di Legnano: lead
• Acelity: collaborator

Related Publications (1)

• 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.

  PMID: 29730777 RESULT

MeSH Terms

Conditions

Obesity, Morbid; Obesity; Obesity, Abdominal; Wounds and Injuries; Wound Infection; Abdominal Injuries; Surgical Wound; Surgical Wound Infection; Cicatrix; Seroma; Hematoma; Inflammation

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Postoperative Complications; Pathologic Processes; Fibrosis; Hemorrhage

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Silvio Abatangelo, M.D.

  ASST Ovest Milanese

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvio Abatangelo, M.D.

CONTACT

+39 (02) 97 96 3466; caps.trial@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Analysis of data and statistical analysis will be blinded to groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Plastic Surgeon - Physician

Model Details: Case-control Experimental/Interventional Group: post-operative ciNPT (first 7 days) Control Group: post-operative standard wound care

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: January 2, 2020
• Study Start: February 1, 2020
• Primary Completion: November 1, 2022
• Study Completion: January 31, 2023
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share