Negative Pressure Wound Therapy for Wound Healing After Stoma Reversal (NESTOR)

Istituto Clinico Humanitas

Status

Unknown

Conditions

Stoma Site Infection

Treatments

Device: PICO™ 7

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03781206

824

Details and patient eligibility

About

Stoma reversal is associated with high incidence of post-surgical complications, including Surgical Site Infections (SSI). Negative Pressure Wound Therapy (NPWT) has been successfully applied to surgical wound management, reducing the SSIs incidence. This is a randomized open-label trial to assess the efficacy of NPWT in decreasing the rate of SSI after stoma reversal.

Full description

Stoma reversal after abdominal resection is associated with several complications, of which the most common is wound infection. Surgical Site Infections (SSI) usually result in increased long-term complications, such as incisional hernia, prolonged hospital stay, increased outpatients visits and medical costs. Negative-Pressure-Wound-Therapy (NPWT) is a technique using vacuum dressing, commonly used to promote surgical wound healing, but there is a significant lack of knowledge about its safety and efficacy in promoting wound healing after stoma closure. This is an interventional, randomized, open label trial to evaluate the safety and efficacy of the NPWT (PICO™ system, Smith&Nephew Healthcare, Hull, UK) on stoma wound compared to Standard of Care (SOC).

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age >18 years, any sex;
Patients who underwent elective open or laparoscopic rectal resection ostomy construction (loop/end ileostomy; loop/end colostomy) for either oncological and Inflammatory Bowel Disease (IBD) indications;
Normal water contrast enema prior to surgery;
Both neo-adjuvant and adjuvant treatment are allowed for cancer patients;
Both immunosuppressant and biological medications are allowed for IBD patients.

Exclusion criteria

Patients age at screening < 18 years;
Pregnant or breastfeeding women;
Neurodegenerative disorders or psychiatric diseases;
Contraindications or hypersensitivity to the use of the investigational product or its components;
Patients with skin features (e.g., tattoos, pre-existing scarring) which could interfere with the study assessments;
Patients with post-operative bleeding (to be assessed 24 hours after surgery).