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NCT04955730 Clinical Trial

NPWT in Patients Undergoing Surgical Procedures for Management of GI Malignancies

Surgical Wound Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04955730
Other study ID # MCC-20561
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date August 5, 2021
Est. completion date July 2025

Study information
Verified date May 2024
Source H. Lee Moffitt Cancer Center and Research Institute
Contact Jose Pimiento, MD
Phone 813-745-1277
Email Jose.Pimiento@moffitt.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date July 2025
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Moffitt Cancer Center Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Surgical Site Infection - Superficial Incisional Investigators will measure rate of Surgical Site Infection (SSI) of participants who received Superficial Incisions. 30 days post operation
Primary Surgical Site Infection - Deep Incisional Investigators will measure rate of Surgical Site Infection (SSI) of participants who received Deep Incisions. 30 days post operation
Primary 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 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
Secondary 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
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