Status:
UNKNOWN
Negative Pressure Wound Therapy for Wound Healing After Stoma Reversal
Lead Sponsor:
Istituto Clinico Humanitas
Collaborating Sponsors:
Smith & Nephew, Inc.
Conditions:
Stoma Site Infection
Eligibility:
All Genders
18+ years
Phase:
NA
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 surgi...
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 com...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03781206
Start Date
July 18 2019
End Date
June 1 2021
Last Update
February 5 2021
Active Locations (1)
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1
Humanitas Research Hospital
Rozzano, MI, Italy, 20089