UnknownNot Applicable

Negative Pressure Wound Therapy for Wound Healing After Stoma Reversal

Italy100 participantsStarted 2019-07-18

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Surgical Site Infection (SSI) rate comparison

Timeframe: Post-operative day 7

Surgical Site Infection (SSI) rate comparison

Timeframe: Post-operative day 30

Trial details

NCT IDNCT03781206

SponsorIstituto Clinico Humanitas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03-01

Contact for this trial

Annalisa Maroli, PhD

+39 02 8224 7776 annalisa.maroli@humanitas.it

View on ClinicalTrials.gov More Stoma Site Infection trials