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

Not Applicable

Withdrawn

• Conditions: Surgical Site Infection; Wound Infection; Surgical Wound; Surgical Incision

• Registration Number: NCT04110353
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2019-09-20
• Study First Submitted QC: 2019-09-27
• Study First Posted: 2019-10-01
• Study Start: 2020-06
• Primary Completion: 2021-06
• Study Completion: 2022-06
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Wound dressings - use of	Up to day 30-40	Time to discontinuation of dressings, type and number of dressings used
Long term follow up - Hernia occurrence	At 1, 3 and 5 years	Development of incisional hernia
Ninety day mortality rate	Up to day 90	Mortality within 90 days
Microscopy, culture and sensitivity results from swabs of any Surgical Site Infections	Within 30 days	Culture results if SSI post-operative (including sensitivities)
Ninety day readmission rate	Up to day 90	Rate of readmission within 90 days
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)
Number of adverse reactions to treatments for Surgical Site Infections	Within 30 days	Adverse reactions to antibiotics given or to dressings use
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
Post operative complications - other	Within 30 days	Occurrence of other post-operative complications
Cause of death	Up to day 90	Cause of death for any mortalities within 90 days
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