Negative Pressure Wound Therapy for Wound Healing After Stoma Reversal

NCT ID: NCT03781206

Last Updated: 2021-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-18
• Study Completion Date: 2021-06-01

Brief Summary

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.

Detailed 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).

Conditions

Stoma Site Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard of Care (SOC)

After stoma reversal, patients of SOC group will be treated as for normal clinical practice, using a simple adhesive wound dressing.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Negative Pressure Wound Therapy (NPWT)

PICO™ 7 will be applied after stoma reversal

Group Type: EXPERIMENTAL

PICO™ 7

Intervention Type: DEVICE

PICO™ system (Smith\&Nephew Healthcare, Hull, UK) is a Single-Use Negative Pressure Wound Therapy (NPWT) System consisting of a small portable pump, 2 lithium batteries, 2 dressings and fixation strips.

Interventions

PICO™ 7

PICO™ system (Smith\&Nephew Healthcare, Hull, UK) is a Single-Use Negative Pressure Wound Therapy (NPWT) System consisting of a small portable pump, 2 lithium batteries, 2 dressings and fixation strips.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: collaborator

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonino Spinelli, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas

Locations

Humanitas Research Hospital

Rozzano, MI, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Annalisa Maroli, PhD

Role: CONTACT

annalisa.maroli@humanitas.it

+39 02 8224 7776

Facility Contacts

Humanitas R Hospital

Role: primary

annalisa.maroli@humanitas.it

0282247776

Role: backup

antonino.spinelli@humanitas.it

Other Identifiers

824

Identifier Type: -

Identifier Source: org_study_id