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

Imperial College London

Status: Withdrawn

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

Treatments: Other: Wound dressings: Conservative dressings; Other: Wound dressings: Prevena dressings; Other: Wound dressings: ciVAC dressings

Study type: Interventional

Funder types: Other

Identifiers

NCT04110353

19IC5400

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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0 participants in 3 patient groups

Conservative dressings

Active Comparator group

Description:

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

Treatment:

Other: Wound dressings: Conservative dressings

Prevena dressing

Active Comparator group

Description:

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

Treatment:

Other: Wound dressings: Prevena dressings

ciVAC dressing

Active Comparator group

Description:

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

Treatment:

Other: Wound dressings: ciVAC dressings