NPWT in Patients Undergoing Surgical Procedures for Management of GI Malignancies

Phase 2

Active, not recruiting

• Conditions: Surgical Wound Infection
• Interventions: Device: Negative Pressure Wound Therapy

• Registration Number: NCT04955730
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

This randomized trial will use a Negative Pressure Wound Therapy device or standard wound closure, in participants with gastrointestinal neoplasms, to measure the rate of surgical site infections

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-29
• Study First Submitted QC: 2021-07-07
• Study First Posted: 2021-07-09
• Study Start: 2021-08-05
• Primary Completion: 2025-04-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Scheduled surgical procedure for the management of gastrointestinal cancer
• Scheduled surgical procedure planned for incision that will result in wound >5cm
• Scheduled surgical procedure planned for skin wound that will be closed by primary intention with either: Staples covered by sterile Telfa® and Tegaderm® or Medipore® OR Dermal or subcuticular sutures covered by Octil®
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria

• Scheduled surgical procedure where wound considered dirty
• Scheduled surgical procedure for wound left for closure by secondary intention
• Emergency surgery
• Pregnancy. Pregnancy status is confirmed per protocol the day of surgery in the preoperative space by urine pregnancy test in patient younger than 65 and with intact uterus. Pregnant patient will be excluded from this study
• History or current diagnosis of any medical or psychological condition that in the Investigator's opinion, might interfere with the subject's ability to participate in the study or the inability to obtain informed consent because of psychiatric or complicating medical problems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NPWT - Negative Pressure Wound Therapy	Negative Pressure Wound Therapy	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.

Primary Outcome Measures

Name	Time	Method
Surgical Site Infection - Organ/Space Incisional	30 days post operation	Investigators will measure rate of Surgical Site Infection (SSI) of participants who received Organ/Space Incisions.
Surgical Site Infection - Superficial Incisional	30 days post operation	Investigators will measure rate of Surgical Site Infection (SSI) of participants who received Superficial Incisions.
Surgical Site Infection - Deep Incisional	30 days post operation	Investigators will measure rate of Surgical Site Infection (SSI) of participants who received Deep Incisions.

Secondary Outcome Measures

Name	Time	Method
Return to Intended Oncologic Therapy (RIOT)	Up to 12 months after surgery	Investigators will measure number of participants who returned to their intended oncologic therapy
Time to Initiation of Planned Oncologic Therapy	Up to 12 months after surgery	Investigators will measure time to initiation planned therapy from the surgery date to initiation date of planned oncologic therapy

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States