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Prophylactic Closed Incision Negative Pressure Wound Therapy on Abdominal Wounds - Clinical and Economic Perspectives (ProNounCE)

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ClinicalTrials.gov Identifier: NCT04110353
Recruitment Status : Not yet recruiting
First Posted : October 1, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief Summary:
This study evaluates whether specialist negative pressure dressings reduce the risk of wound infections after operations when compared to conservative dressings, and if one negative pressure dressings works better than another. The study will look at patients who have had an open operation on their bowel and the wound closed at the end of the operation.

Condition or disease Intervention/treatment Phase
Wound Infection Surgical Site Infection Surgical Wound Surgical Incision Other: Wound dressings: Conservative dressings Other: Wound dressings: Prevena dressings Other: Wound dressings: ciVAC dressings Not Applicable

Detailed Description:

Surgical site infections (SSI) can affect up 41% of patients post-operatively. They are associated with significant healthcare and patient costs, and increased patient morbidity and mortality.

Specialist post operative dressings with negative pressure wound therapy are available, and the WHO do recommended for use in high risk wounds, taking resources into account. However no further recommendations are available.

This study will explore the rate of post-operative wound infections in adult patients undergoing open abdominal surgery on the bowel, and compare the rate of wound infections in these patients in relation to three different dressing types used after their operation. The study aims to determine if any of the dressings used within the study are associated with lower post-operative wound infection rates, and compare the overall costs of using each dressing type, including both direct healthcare costs and societal costs. Finally, it will evaluate participant's quality of life outcomes after open abdominal surgery, specifically relating to their wound.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 570 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Stepped wedge design with randomisation at the level of the Hospitals not individual patients
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prophylactic Closed Incision Negative Pressure Wound Therapy on Abdominal Wounds - Clinical and Economic Perspectives: A Multi-centre Randomised Trial
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Conservative dressings
Use of simple dressings on wound post operatively - to be placed at end of operation
Other: Wound dressings: Conservative dressings
Conservative dressings to be placed on closed wounds post operatively, after open operations on the bowel. To be changed at day 7 or sooner if clinically indicated.

Active Comparator: Prevena dressing
Use of Prevena(KCI) dressing on wound post operatively - to be placed at end of operation
Other: Wound dressings: Prevena dressings
Prevena dressing to be placed on closed wounds post operatively, after open operations on the bowel. To be changed at day 7 or sooner if clinically indicated.

Active Comparator: ciVAC dressing
Use of closed incision VAC (vacuum assisted closure) dressing on wound post operatively - to be placed at end of operation
Other: Wound dressings: ciVAC dressings
Closed incision VAC dressings to be placed on closed wounds post operatively, after open operations on the bowel. To be changed at day 7 or sooner if clinically indicated.




Primary Outcome Measures :
  1. Surgical Site Infection [ Time Frame: Up to day 90 ]
    The occurrence of surgical site infections at the post-operative wound and timeframe of occurrence


Secondary Outcome Measures :
  1. Wound assessments - clinical assessment of presence of wound complication and healing [ Time Frame: At day 7 (on removal of dressing), up to day 30 (on discharge), day 40 (at outpatient follow up) ]
    Independent blind assessment of wounds at day 7 post operatively, on discharge and at outpatient follow up, via wound photographs taken, and correlation with assessment by clinical team

  2. Length of stay [ Time Frame: Up to 90 days ]
    Length of stay post-operatively

  3. Number of additional interventions received by participants due to development of a Surgical Site Infection [ Time Frame: Within 30 days ]
    Need for intervention or treatment for surgical site infection (antibiotics, opening up of wound at bedside, operative or radiological intervention)

  4. Microscopy, culture and sensitivity results from swabs of any Surgical Site Infections [ Time Frame: Within 30 days ]
    Culture results if SSI post-operative (including sensitivities)

  5. Post operative complications - other [ Time Frame: Within 30 days ]
    Occurrence of other post-operative complications

  6. Number of adverse reactions to treatments for Surgical Site Infections [ Time Frame: Within 30 days ]
    Adverse reactions to antibiotics given or to dressings use

  7. Wound dressings - use of [ Time Frame: Up to day 30-40 ]
    Time to discontinuation of dressings, type and number of dressings used

  8. Ninety day mortality rate [ Time Frame: Up to day 90 ]
    Mortality within 90 days

  9. Ninety day readmission rate [ Time Frame: Up to day 90 ]
    Rate of readmission within 90 days

  10. Cause of death [ Time Frame: Up to day 90 ]
    Cause of death for any mortalities within 90 days

  11. Quality of life measures: EuroQol 5 Dimensions 5 Levels (EQ5D5L) questionnaire [ Time Frame: At day 7 (on removal of dressing), up to day 30 (on discharge), day 40 (at outpatient follow up) ]
    Generic quality of life outcome measures using EQ5D5L questionnaire assessed at day 7 post operatively, on discharge and at outpatient follow up; individualised questions, no formal scale

  12. Quality of life measures: Wound Quality of Life questionnaires [ Time Frame: At day 7 (on removal of dressing), up to day 30 (on discharge), day 40 (at outpatient follow up) ]
    Wound specific quality of life outcome measures using Wound Quality of Life questionnaire assessed at day 7 post operatively, on discharge and at outpatient follow up; scales - not at all/a little/moderately/quite a lot/very much

  13. Quality of life and economic measures: Economic assessment questionnaire [ Time Frame: At day 40 ]
    Assessment of economic impact of wound using single Economic questionnaire to be assessed at day 40; individualised questions that will be assessed, no formal scale

  14. Long term follow up - Hernia occurrence [ Time Frame: At 1, 3 and 5 years ]
    Development of incisional hernia



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

Inclusion Criteria:

  • Emergency, trauma or elective contaminated abdominal operations within general surgery and/or colorectal surgery
  • Abdominal wounds closed at time of operation and expected to heal by primary intention
  • Patients who have the capacity to consent
  • To include complex abdominal wounds with existing infection where wounds have been closed and expected to heal by primary intention
  • To including graft or flap sites as part of general surgical procedure
  • Patients who are able to complete questionnaires post operatively, either alone or with assistance

Exclusion Criteria:

  • Wounds where an appropriate seal cannot be obtained
  • Wounds left open and expected to heal by secondary intention
  • Patients known to have allergy or sensitivity to dressings being used
  • Patients who lack the capacity to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110353


Contacts
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Contact: Eman Alkizwini 020 8235 4020 eman.alkizwini@nhs.net

Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Christopher Peters Imperial College London
Study Chair: Carolynne Vaizey St Mark's Hospital and Academic Institute
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT04110353    
Other Study ID Numbers: 19IC5400
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Surgical Site infections
Negative Pressure Wound Therapy
Contaminated abdominal wounds
Closed incision abdominal wound
Prophylactic therapy
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Wounds and Injuries
Surgical Wound
Postoperative Complications
Pathologic Processes