Negative Pressure Wound Therapy for Wound Healing After Stoma Reversal
NESTOR
Efficacy of Negative Pressure Wound Therapy (NPWT) for Prevention of Wound Infection and Improvement of Wound Healing After Stoma Reversal
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2018
CompletedFirst Posted
Study publicly available on registry
December 19, 2018
CompletedStudy Start
First participant enrolled
July 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedFebruary 5, 2021
February 1, 2021
1.6 years
December 13, 2018
February 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Surgical Site Infection (SSI) rate comparison
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
Post-operative day 7
Surgical Site Infection (SSI) rate comparison
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
Post-operative day 30
Secondary Outcomes (9)
Wound healing timing comparison
Post-operative day 30
Quality of life assessment
Post-operative day 7
Quality of life assessment
Post-operative day 30
Quality of life assessment
Post-operative day 90
Quality of life assessment
Post-operative day 180
- +4 more secondary outcomes
Study Arms (2)
Standard of Care (SOC)
NO INTERVENTIONAfter stoma reversal, patients of SOC group will be treated as for normal clinical practice, using a simple adhesive wound dressing.
Negative Pressure Wound Therapy (NPWT)
EXPERIMENTALPICO™ 7 will be applied after stoma reversal
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Istituto Clinico Humanitaslead
- Smith & Nephew, Inc.collaborator
Study Sites (1)
Humanitas Research Hospital
Rozzano, MI, 20089, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antonino Spinelli, MD, PhD
Istituto Clinico Humanitas
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2018
First Posted
December 19, 2018
Study Start
July 18, 2019
Primary Completion
March 1, 2021
Study Completion
June 1, 2021
Last Updated
February 5, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share