Clinical trial NCT03781206: Negative Pressure Wound Therapy for Wound Healing After Stoma Reversal
Official title: Efficacy of Negative Pressure Wound Therapy (NPWT) for Prevention of Wound Infection and Improvement of Wound Healing After Stoma Reversal
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stoma Site Infection
Keywords: Stoma
Surgical Site Infection
Negative Pressure Wound Therapy
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
Collaborators: name: Smith & Nephew, Inc.
First posted: 2018-12-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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).

Primary outcomes:
measure: Surgical Site Infection (SSI) rate comparison
timeFrame: Post-operative day 7
measure: Surgical Site Infection (SSI) rate comparison
timeFrame: Post-operative day 30
Secondary outcomes:
measure: Wound healing timing comparison
timeFrame: Post-operative day 30
measure: Quality of life assessment
timeFrame: Post-operative day 7
measure: Quality of life assessment
timeFrame: Post-operative day 30
measure: Quality of life assessment
timeFrame: Post-operative day 90
measure: Quality of life assessment
timeFrame: Post-operative day 180
measure: Pain assessment
timeFrame: Post-operative day 7
measure: Pain assessment
timeFrame: Post-operative day 30
measure: Pain assessment
timeFrame: Post-operative day 90
measure: Pain assessment
timeFrame: Post-operative day 180
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
state: MI
Study officials:
affiliation: Istituto Clinico Humanitas
name: Antonino Spinelli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: