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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prophylactic Closed Incision Negative Pressure Wound Therapy on Abdominal Wounds - Clinical and Economic Perspectives: A Multi-centre Randomised Trial

Conditions
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Wound Infection, Surgical Site Infection, Surgical Wound, Surgical Incision

Intervention / Treatment
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* Other: Wound dressings: Conservative dressings
* Other: Wound dressings: Prevena dressings
* Other: Wound dressings: ciVAC dressings


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Stepped wedge design with randomisation at the level of the Hospitals not individual patients
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conservative dressings<br>Use of simple dressings on wound post operatively - to be placed at end of operation | Other: Wound dressings: Conservative dressings<br>* 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.<br>|
| Active Comparator: Prevena dressing<br>Use of Prevena(KCI) dressing on wound post operatively - to be placed at end of operation | Other: Wound dressings: Prevena dressings<br>* 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.<br>|
| Active Comparator: ciVAC dressing<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Site Infection | The occurrence of surgical site infections at the post-operative wound and timeframe of occurrence | Up to day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound assessments - clinical assessment of presence of wound complication and healing | 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 | At day 7 (on removal of dressing), up to day 30 (on discharge), day 40 (at outpatient follow up) | 
| Length of stay | Length of stay post-operatively | Up to 90 days | 
| Number of additional interventions received by participants due to development of a Surgical Site Infection | Need for intervention or treatment for surgical site infection (antibiotics, opening up of wound at bedside, operative or radiological intervention) | Within 30 days | 
| Microscopy, culture and sensitivity results from swabs of any Surgical Site Infections | Culture results if SSI post-operative (including sensitivities) | Within 30 days | 
| Post operative complications - other | Occurrence of other post-operative complications | Within 30 days | 
| Number of adverse reactions to treatments for Surgical Site Infections | Adverse reactions to antibiotics given or to dressings use | Within 30 days | 
| Wound dressings - use of | Time to discontinuation of dressings, type and number of dressings used | Up to day 30-40 | 
| Ninety day mortality rate | Mortality within 90 days | Up to day 90 | 
| Ninety day readmission rate | Rate of readmission within 90 days | Up to day 90 | 
| Cause of death | Cause of death for any mortalities within 90 days | Up to day 90 | 
| Quality of life measures: EuroQol 5 Dimensions 5 Levels (EQ5D5L) questionnaire | 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 | At day 7 (on removal of dressing), up to day 30 (on discharge), day 40 (at outpatient follow up) | 
| Quality of life measures: Wound Quality of Life questionnaires | 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 | At day 7 (on removal of dressing), up to day 30 (on discharge), day 40 (at outpatient follow up) | 
| Quality of life and economic measures: Economic assessment questionnaire | 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 | At day 40 | 
| Long term follow up - Hernia occurrence | Development of incisional hernia | At 1, 3 and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical Site infections, Negative Pressure Wound Therapy, Contaminated abdominal wounds, Closed incision abdominal wound, Prophylactic therapy