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

Surgical Site Infection Clinical Trial

— ProNounCE  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04110353
• Other study ID #: 19IC5400
• Status: Withdrawn
• Phase: N/A
• Start date: June 2020
• Est. completion date: June 2022

Study information

• Verified date: September 2023
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2022
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Surgical Incision
• Surgical Site Infection
• Surgical Wound
• Surgical Wound Infection
• Wound Infection
• Wounds and Injuries

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Site Infection	The occurrence of surgical site infections at the post-operative wound and timeframe of occurrence	Up to day 90
Secondary	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)
Secondary	Length of stay	Length of stay post-operatively	Up to 90 days
Secondary	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
Secondary	Microscopy, culture and sensitivity results from swabs of any Surgical Site Infections	Culture results if SSI post-operative (including sensitivities)	Within 30 days
Secondary	Post operative complications - other	Occurrence of other post-operative complications	Within 30 days
Secondary	Number of adverse reactions to treatments for Surgical Site Infections	Adverse reactions to antibiotics given or to dressings use	Within 30 days
Secondary	Wound dressings - use of	Time to discontinuation of dressings, type and number of dressings used	Up to day 30-40
Secondary	Ninety day mortality rate	Mortality within 90 days	Up to day 90
Secondary	Ninety day readmission rate	Rate of readmission within 90 days	Up to day 90
Secondary	Cause of death	Cause of death for any mortalities within 90 days	Up to day 90
Secondary	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)
Secondary	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)
Secondary	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
Secondary	Long term follow up - Hernia occurrence	Development of incisional hernia	At 1, 3 and 5 years