NPWT in Patients Undergoing Surgical Procedures for Management of GI Malignancies

Study Overview
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Brief Summary
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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

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

Conditions
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Surgical Wound Infection

Intervention / Treatment
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* Device: Negative Pressure Wound Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NPWT - Negative Pressure Wound Therapy<br>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<br>* 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.<br>* Other names: PICO;|
| No Intervention: Standard of Care Wound Therapy<br>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?
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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 |