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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Surgical Wound; Surgical Site Infection; Wound Infection; Surgical Incision
• Intervention / Treatment: Other: Wound dressings: Conservative dressings; Other: Wound dressings: Prevena dressings; Other: Wound dressings: ciVAC dressings

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Imperial College London
• Investigators: Principal Investigator: Christopher Peters, Imperial College London; Study Chair: Carolynne Vaizey, St Mark's Hospital and Academic Institute

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2020
• Primary Completion (Estimated): June 1, 2021
• Study Completion (Estimated): June 1, 2022

Study Registration Dates

• First Submitted: September 20, 2019
• First Submitted That Met QC Criteria: September 27, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Negative Pressure Wound Therapy; Prophylactic therapy; Surgical Site infections; Contaminated abdominal wounds; Closed incision abdominal wound
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Infections; Communicable Diseases; Wounds and Injuries; Surgical Wound; Surgical Wound Infection; Wound Infection
• Other Study ID Numbers: 19IC5400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No