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

Imperial College London

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Conditions

Wound Infection Surgical Site Infection Surgical Wound Surgical Incision

Interventions

Wound dressings: Conservative dressingsOTHER

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 dressingsOTHER

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 dressingsOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Surgical Site Infection

The occurrence of surgical site infections at the post-operative wound and timeframe of occurrence

Time frame: Up to day 90

Secondary Outcomes

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

Time frame: 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

Time frame: 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)

Time frame: Within 30 days

Microscopy, culture and sensitivity results from swabs of any Surgical Site Infections

Culture results if SSI post-operative (including sensitivities)

Time frame: Within 30 days

Post operative complications - other

Occurrence of other post-operative complications

Time frame: Within 30 days

Number of adverse reactions to treatments for Surgical Site Infections

Adverse reactions to antibiotics given or to dressings use

Data from ClinicalTrials.gov

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