NPWT in Patients Undergoing Surgical Procedures for Management of GI Malignancies

Randomized Trial of Prolonged Use of Negative Pressure Wound Therapy in Patients Undergoing Surgical Procedures for the Management of Gastrointestinal Malignancies

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

Study Overview

• Status: Active, not recruiting
• Conditions: Surgical Wound Infection
• Intervention / Treatment: Device: Negative Pressure Wound Therapy

• Study Type: Interventional
• Enrollment (Actual): 290
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NPWT - 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.	Device: Negative Pressure Wound Therapy; Negative Pressure Wound Therapy is a single use NPWT that produces a negative pressure at -80 mmHg. Participants will have their fascia and skin closed in the same manner as the control arm participants, and will wear the NPWT dressing for 7 days after surgery.; Other Names: PICO
No Intervention: Standard of Care Wound Therapy; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Investigators: Principal Investigator: Daniel Anaya, MD, Moffitt Cancer Center; Principal Investigator: Jose M Pimiento, MD, Moffitt Cancer Center

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trial Search

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2021
• Primary Completion (Actual): April 30, 2025
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Infections; Wound Infection; Pathological Conditions, Signs and Symptoms; Surgical Wound Infection; Therapeutics; Surgical Procedures, Operative; Drainage; Wound Closure Techniques; Negative-Pressure Wound Therapy
• Other Study ID Numbers: MCC-20561

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes