NPWT in Patients Undergoing Surgical Procedures for Management of GI Malignancies

H. Lee Moffitt Cancer Center and Research Institute

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Surgical Wound Infection

Treatments: Device: Negative Pressure Wound Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04955730

MCC-20561

Details and patient eligibility

About

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

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups

NPWT - Negative Pressure Wound Therapy

Experimental group

Description:

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.

Treatment:

Device: Negative Pressure Wound Therapy

Standard of Care Wound Therapy

No Intervention group

Description:

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.