4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / NPWT in Patients Undergoing Surgical Procedures for Management of GI Malignancies

NPWT in Patients Undergoing Surgical Procedures for Management of GI Malignancies

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

Condition or disease Intervention/treatment Phase
Surgical Wound Infection Device: Negative Pressure Wound Therapy Phase 2 Phase 3

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Participants, investigators and statisticians will be blinded to treatment randomization but the surgeons will not.
Primary Purpose: Supportive Care
Official Title: Randomized Trial of Prolonged Use of Negative Pressure Wound Therapy in Patients Undergoing Surgical Procedures for the Management of Gastrointestinal Malignancies
Actual Study Start Date : June 24, 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : October 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: NPWT - Negative Pressure Wound Therapy
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
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 Name: PICO
No Intervention: Standard of Care Wound Therapy
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.
Outcome Measures
Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled surgical procedure for the management of gastrointestinal cancer
  • Have a surgical wound bigger than 5cm
  • Skin wound 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:

  • Wound considered dirty (class IV per wound classification)
  • 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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Jose Pimiento, MD 813-745-1277 Jose.Pimiento@moffitt.org
Contact: Daniel Anaya, MD 813-745-6898 Daniel.Anaya@moffitt.org

Locations
Layout table for location information
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Victoria Kryliouk    813-745-6688    Victoria.Kryliouk@moffitt.org   
Contact: Jose Pimiento, MD    813-745-1277    Jose.Pimiento@moffitt.org   
Principal Investigator: Jose Pimiento, MD         
Principal Investigator: Daniel Anaya, MD         
Sub-Investigator: Michael J Schell, PhD         
Sub-Investigator: John Green, MD         
Sub-Investigator: Julian Sanchez, MD         
Sub-Investigator: Sean Dineen, MD         
Sub-Investigator: Sophie Dessureault, MD         
Sub-Investigator: Pamela J Hodul, MD         
Sub-Investigator: Mokenge Malafa, MD         
Sub-Investigator: Jason Fleming, MD         
Sub-Investigator: Seth Felder, MD         
Sub-Investigator: Jason Denbo, MD         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Jose M Pimiento, MD Moffitt Cancer Center
Principal Investigator: Daniel Anaya, MD Moffitt Cancer Center
Tracking Information
First Submitted Date  ICMJE June 29, 2021
First Posted Date  ICMJE July 9, 2021
Last Update Posted Date December 15, 2021
Actual Study Start Date  ICMJE June 24, 2021
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2021)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2021)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NPWT in Patients Undergoing Surgical Procedures for Management of GI Malignancies
Official Title  ICMJE Randomized Trial of Prolonged Use of Negative Pressure Wound Therapy in Patients Undergoing Surgical Procedures for the Management of Gastrointestinal Malignancies
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Participants, investigators and statisticians will be blinded to treatment randomization but the surgeons will not.
Primary Purpose: Supportive Care
Condition  ICMJE Surgical Wound Infection
Intervention  ICMJE 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.
Other Name: PICO
Study Arms  ICMJE
  • Experimental: NPWT - Negative Pressure Wound Therapy
    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.
    Intervention: Device: Negative Pressure Wound Therapy
  • No Intervention: Standard of Care Wound Therapy
    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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 7, 2021) 		300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2023
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Scheduled surgical procedure for the management of gastrointestinal cancer
  • Have a surgical wound bigger than 5cm
  • Skin wound 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:

  • Wound considered dirty (class IV per wound classification)
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jose Pimiento, MD 813-745-1277 Jose.Pimiento@moffitt.org
Contact: Daniel Anaya, MD 813-745-6898 Daniel.Anaya@moffitt.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04955730
Other Study ID Numbers  ICMJE MCC-20561
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party H. Lee Moffitt Cancer Center and Research Institute
Study Sponsor  ICMJE H. Lee Moffitt Cancer Center and Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jose M Pimiento, MD Moffitt Cancer Center
Principal Investigator: Daniel Anaya, MD Moffitt Cancer Center
PRS Account H. Lee Moffitt Cancer Center and Research Institute
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP