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

Sponsor

Imperial College London (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04110353

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Stepped wedge design with randomisation at the level of the Hospitals not individual patientsStepped 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

Anticipated Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Jun 1, 2021

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Surgical Site Infection [Up to day 90]
The occurrence of surgical site infections at the post-operative wound and timeframe of occurrence

Secondary Outcome Measures

Wound assessments - clinical assessment of presence of wound complication and healing [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
Length of stay [Up to 90 days]
Length of stay post-operatively
Number of additional interventions received by participants due to development of a Surgical Site Infection [Within 30 days]
Need for intervention or treatment for surgical site infection (antibiotics, opening up of wound at bedside, operative or radiological intervention)
Microscopy, culture and sensitivity results from swabs of any Surgical Site Infections [Within 30 days]
Culture results if SSI post-operative (including sensitivities)
Post operative complications - other [Within 30 days]
Occurrence of other post-operative complications
Number of adverse reactions to treatments for Surgical Site Infections [Within 30 days]
Adverse reactions to antibiotics given or to dressings use
Wound dressings - use of [Up to day 30-40]
Time to discontinuation of dressings, type and number of dressings used
Ninety day mortality rate [Up to day 90]
Mortality within 90 days
Ninety day readmission rate [Up to day 90]
Rate of readmission within 90 days
Cause of death [Up to day 90]
Cause of death for any mortalities within 90 days
Quality of life measures: EuroQol 5 Dimensions 5 Levels (EQ5D5L) questionnaire [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
Quality of life measures: Wound Quality of Life questionnaires [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
Quality of life and economic measures: Economic assessment questionnaire [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
Long term follow up - Hernia occurrence [At 1, 3 and 5 years]
Development of incisional hernia

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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