NPWT in Patients Undergoing Surgical Procedures for Management of GI Malignancies

NCT04955730 | Active Not Recruiting Phase 2 Results DMC FDA Device

• 1 other identifier: MCC-20561
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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

Conditions

Surgical Wound Infection

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Return to Intended Oncologic Therapy (RIOT)

  Up to 12 months after surgery

• Time to Initiation of Planned Oncologic Therapy

  Up to 12 months after surgery

Study Arms (2)

NPWT - Negative Pressure Wound Therapy

EXPERIMENTAL

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

Standard of Care Wound Therapy

NO INTERVENTION

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.

Interventions

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.

Also known as: PICO

NPWT - Negative Pressure Wound Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trial Search

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Results Point of Contact

• Title: Jose M. Pimiento, MD
• Organization: Moffitt Cancer Center

Jose.Pimiento@moffitt.org

813-745-3237

Study Officials

• Jose M Pimiento, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

• Daniel Anaya, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, investigators and statisticians will be blinded to treatment randomization. Surgical oncologists will be blinded of treatment randomization until the dressing is applied to the wound.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 9, 2021
• Study Start: August 5, 2021
• Primary Completion: April 30, 2025
• Study Completion: March 1, 2026
• Last Updated: March 2, 2026
• Results First Posted: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)