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OpenTrials
Completed

NCT Number: NCT04955730

NPWT in Patients Undergoing Surgical Procedures for Management of GI 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

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Key information

Conditions

Surgical Wound Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Negative pressure wound therapy

Device

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

Primary outcomes

  1. Surgical Site Infection - Superficial Incisional

    Time frame: 30 days post operation

    Investigators will measure rate of Surgical Site Infection (SSI) of participants who received Superficial Incisions.

  2. Surgical Site Infection - Deep Incisional

    Time frame: 30 days post operation

    Investigators will measure rate of Surgical Site Infection (SSI) of participants who received Deep Incisions.

  3. Surgical Site Infection - Organ/Space Incisional

    Time frame: 30 days post operation

    Investigators will measure rate of Surgical Site Infection (SSI) of participants who received Organ/Space Incisions.

Secondary outcomes

  1. Return to Intended Oncologic Therapy (RIOT)

    Time frame: Up to 12 months after surgery

    Investigators will measure number of participants who returned to their intended oncologic therapy

  2. Time to Initiation of Planned Oncologic Therapy

    Time frame: 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

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 9, 2021
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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