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NPWT in Patients Undergoing Surgical Procedures for Management of GI Malignancies

Primary Purpose

Surgical Wound Infection

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Negative Pressure Wound Therapy

About this trial

This is an interventional supportive care trial for Surgical Wound Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Moffitt Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

NPWT - Negative Pressure Wound Therapy

Standard of Care Wound Therapy

Arm 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.

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.

Outcomes

Primary Outcome Measures

Surgical Site Infection - Superficial Incisional

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

Surgical Site Infection - Deep Incisional

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

Surgical Site Infection - Organ/Space Incisional

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

Secondary Outcome Measures

Return to Intended Oncologic Therapy (RIOT)

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

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

Full Information

NCT ID

NCT04955730

First Posted

June 29, 2021

Last Updated

October 17, 2023

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT04955730

Brief Title

NPWT in Patients Undergoing Surgical Procedures for Management of GI Malignancies

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 5, 2021 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

H. Lee Moffitt Cancer Center and Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Surgical Wound Infection

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

NPWT - Negative Pressure Wound Therapy

Arm Type

Experimental

Arm Description

Arm Title

Standard of Care Wound Therapy

Arm Type

No Intervention

Arm 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.

Intervention Type

Device

Intervention Name(s)

Negative Pressure Wound Therapy

Other Intervention Name(s)

PICO

Intervention Description

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.

Primary Outcome Measure Information:

Title

Surgical Site Infection - Superficial Incisional

Description

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

Time Frame

30 days post operation

Title

Surgical Site Infection - Deep Incisional

Description

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

Time Frame

30 days post operation

Title

Surgical Site Infection - Organ/Space Incisional

Description

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

Time Frame

30 days post operation

Secondary Outcome Measure Information:

Title

Return to Intended Oncologic Therapy (RIOT)

Description

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

Time Frame

Up to 12 months after surgery

Title

Time to Initiation of Planned Oncologic Therapy

Description

Investigators will measure time to initiation planned therapy from the surgery date to initiation date of planned oncologic therapy

Time Frame

Up to 12 months after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jose Pimiento, MD

Phone

813-745-1277

Jose.Pimiento@moffitt.org

First Name & Middle Initial & Last Name or Official Title & Degree

Daniel Anaya, MD

Phone

813-745-6898

Daniel.Anaya@moffitt.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jose M Pimiento, MD

Organizational Affiliation

Moffitt Cancer Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Daniel Anaya, MD

Organizational Affiliation

Moffitt Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Moffitt Cancer Center

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Melissa Dautovic

Phone

813-745-3145

Melissa.Dautovic@moffitt.org

First Name & Middle Initial & Last Name & Degree

Jose Pimiento, MD

Phone

813-745-1277

Jose.Pimiento@moffitt.org

First Name & Middle Initial & Last Name & Degree

Jose Pimiento, MD

First Name & Middle Initial & Last Name & Degree

Daniel Anaya, MD

First Name & Middle Initial & Last Name & Degree

Michael J Schell, PhD

First Name & Middle Initial & Last Name & Degree

John Green, MD

First Name & Middle Initial & Last Name & Degree

Julian Sanchez, MD

First Name & Middle Initial & Last Name & Degree

Sean Dineen, MD

First Name & Middle Initial & Last Name & Degree

Sophie Dessureault, MD

First Name & Middle Initial & Last Name & Degree

Pamela J Hodul, MD

First Name & Middle Initial & Last Name & Degree

Mokenge Malafa, MD

First Name & Middle Initial & Last Name & Degree

Jason Fleming, MD

First Name & Middle Initial & Last Name & Degree

Seth Felder, MD

First Name & Middle Initial & Last Name & Degree

Jason Denbo, MD

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://moffitt.org/clinicaltrialssearch?DiseaseSite=&q=20561

Description

Moffitt Cancer Center Clinical Trial Search

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NPWT in Patients Undergoing Surgical Procedures for Management of GI Malignancies

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