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

NCT ID: NCT04110353

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-30
• Study Completion Date: 2022-06-30

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.

Conditions

Wound Infection; Surgical Site Infection; Surgical Wound; Surgical Incision

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Conservative dressings

Use of simple dressings on wound post operatively - to be placed at end of operation

Group Type: ACTIVE_COMPARATOR

Wound dressings: Conservative dressings

Intervention Type: OTHER

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.

Prevena dressing

Use of Prevena(KCI) dressing on wound post operatively - to be placed at end of operation

Group Type: ACTIVE_COMPARATOR

Wound dressings: Prevena dressings

Intervention Type: OTHER

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.

ciVAC dressing

Use of closed incision VAC (vacuum assisted closure) dressing on wound post operatively - to be placed at end of operation

Group Type: ACTIVE_COMPARATOR

Wound dressings: ciVAC dressings

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Peters

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Carolynne Vaizey

Role: STUDY_CHAIR

St Mark's Hospital and Academic Institute

Other Identifiers

19IC5400

Identifier Type: -

Identifier Source: org_study_id