Stoma Site Infection
Conditions
Keywords
Stoma, Surgical Site Infection, Negative Pressure Wound Therapy
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).
Interventions
DEVICEPICO™ 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.
Sponsors
Smith & Nephew, Inc.
Istituto Clinico Humanitas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Site Infection (SSI) rate comparison | Post-operative day 7 | The rate of superficial (infections involving only the skin and subcutaneous tissue) or deep (infections involving the muscle and the fascia but not organ space) SSI will be assessed by medical examination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound healing timing comparison | Post-operative day 30 | Wound healing is defined as complete tissue restoration, scar formation and absence of resected tissues and will be assessed by medical examination |
| Quality of life assessment | Post-operative day 7 | Quality of life will be assessed using the EuroQol-5 Dimension-5 Levels (EQ5D5L) questionnaire. The EQ5D5L questionnaire comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The questionnaire also includes a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. |
| Pain assessment | Post-operative day 7 | Pain will be measured using the McGill Pain questionnaire. The questionnaire presents a list of 78 words in 20 sections that are related to pain. The users mark the words that best describe their pain (multiple markings are allowed). Among the words, sections of these words signify different components of pain: Sensory (sections 1-10), Affective (sections 11-15), Evaluative (section 16), and Miscellaneous (sections 17-20). |
Countries
Italy
Contacts
Primary ContactAnnalisa Maroli, PhD
Outcome results
None listed