UnknownNot Applicable

Protocol Effect of Negative Pressure Drain to Reducing Surgical Site Infection in Surgical Wound of Abdominal Surgery

Thailand130 participantsStarted 2023-04-15

Plain-language summary

Surgical site infection (SSI) is one of main complication in surgery. It usually occurs within 30 days post operation. The superficial SSI is an infection of skin and subcutaneous layer, clinically presented by pus oozing. Furthermore, seroma hematoma and wound dehiscence are also clinical signs of superficial SSI. Nowadays, there are studies which report methods reducing SSI by placing negative pressure drain within surgical wound. It can reduce serum in subcutaneous layer which is found in every surgical wound, especially in clean-contaminated and contaminated wound. Many studies show that placing negative pressure drainage within a surgical wound can reduce superficial SSI and decrease hospital length of stay by comparing with the control group. The objective in this study to compare the rate of SSI of clean-contaminated and contaminated surgical wounds between the patients whose wounds are placed with negative pressure drainage and patients who were not placed with negative pressure drainage.

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: * Patients undergoing intra-abdominal surgery on the upper and lower gastrointestinal tract, pancreas and biliary tract. * Aged 18 years or older * Be in good health and full of consciousness. * Willing to participate in the research study project by signing Exclusion Criteria: * Patients with thrombocytopenia thrombocytopenia or coagulation disorder * The study participant refuses or withdraws from the study.

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

Rate of SSI

Timeframe: post operation day 3

Rate of SSI

Timeframe: post operation day 5

Rate of SSI

Timeframe: post operation day 7

Rate of SSI

Timeframe: post operation day 14

Trial details

NCT IDNCT05865821

SponsorMahidol University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-06

View on ClinicalTrials.gov More Surgical Site Infection trials

Plain-language summary

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.