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Negative Pressure Wound Therapy for Surgical Wound

Phase 2 & 3

Recruiting

Led By Jose M Pimiento, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled surgical procedure for the management of gastrointestinal cancer

Scheduled surgical procedure planned for incision that will result in wound >5cm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months after surgery

Awards & highlights

Study Summary

This trial will compare the rate of surgical site infections in participants who use a Negative Pressure Wound Therapy device to those who use standard wound closure methods.

Who is the study for?

This trial is for adults with gastrointestinal cancer who are scheduled for surgery resulting in a wound larger than 5cm, which will be closed primarily. Participants must consent to the study and commit to its procedures. Excluded are emergency surgeries, dirty wounds, secondary closures, psychological conditions that may interfere with participation, or pregnancy.Check my eligibility

What is being tested?

The trial tests Negative Pressure Wound Therapy (NPWT) against standard wound closure techniques in patients undergoing surgery for gastrointestinal malignancies. The main goal is to compare the rate of surgical site infections between these two methods.See study design

What are the potential side effects?

While specific side effects of NPWT aren't detailed here, common ones include skin irritation around the treatment area, discomfort at the wound site, and rarely bleeding or infection related to therapy application.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for surgery to treat my gastrointestinal cancer.

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I am scheduled for surgery that will result in a wound larger than 5cm.

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My skin wound will be closed with staples or sutures and covered with specific sterile materials.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Surgical Site Infection - Deep Incisional

Surgical Site Infection - Organ/Space Incisional

Surgical Site Infection - Superficial Incisional

Secondary outcome measures

Return to Intended Oncologic Therapy (RIOT)

Time to Initiation of Planned Oncologic Therapy

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: NPWT - Negative Pressure Wound TherapyExperimental Treatment1 Intervention

Participants will receive Negative Pressure Wound Therapy (NPWT) after surgery and wear the NPWT until postop day 3. NPWT dressing will be removed and a new NPWT will be replaced until Postop day 7, where NPWT dressing will be removed.

Group II: Standard of Care Wound TherapyActive Control1 Intervention

Participants will receive standard of care wound therapy after surgery. Postop day 3, dressings will be removed and new sterile dressings will be applied if needed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Negative Pressure Wound Therapy

2019

N/A

~4690

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

542 Previous Clinical Trials

135,192 Total Patients Enrolled

Jose M Pimiento, MDPrincipal InvestigatorMoffitt Cancer Center

1 Previous Clinical Trials

20 Total Patients Enrolled

Daniel Anaya, MDPrincipal InvestigatorMoffitt Cancer Center

Media Library

Negative Pressure Wound Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04955730 — Phase 2 & 3

Surgical Site Infection Research Study Groups: Standard of Care Wound Therapy, NPWT - Negative Pressure Wound Therapy

Surgical Site Infection Clinical Trial 2023: Negative Pressure Wound Therapy Highlights & Side Effects. Trial Name: NCT04955730 — Phase 2 & 3

Negative Pressure Wound Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04955730 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are participating in this research project?

"Yes, this is an ongoing recruitment effort as indicated by the most recent update to the listing on clinicaltrials.gov which was posted on 8/5/2021. The study is looking for 300 individuals who are willing to participate at a single location."

Answered by AI

Are we currently taking applications for this experiment?

"That is accurate, the listing on clinicaltrials.gov says that this study is open for recruitment. The trial was first announced on 8/5/2021 and was last updated on 7/27/2022. They are seeking to enroll 300 patients at 1 location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

NPWT in Patients Undergoing Surgical Procedures for Management of GI Malignancies

2021. "NPWT in Patients Undergoing Surgical Procedures for Management of GI Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04955730.