Surgical Incision, Surgical Site Infection, Surgical Wound, Wound Infection
Conditions
Keywords
Surgical Site infections, Negative Pressure Wound Therapy, Contaminated abdominal wounds, Closed incision abdominal wound, Prophylactic therapy
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.
Interventions
OTHERWound 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.
OTHERWound 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.
OTHERWound 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.
Sponsors
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Stepped wedge design with randomisation at the level of the Hospitals not individual patients
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Site Infection | Up to day 90 | The occurrence of surgical site infections at the post-operative wound and timeframe of occurrence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay | Up to 90 days | Length of stay post-operatively |
| 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) |
| Microscopy, culture and sensitivity results from swabs of any Surgical Site Infections | Within 30 days | Culture results if SSI post-operative (including sensitivities) |
| Post operative complications - other | Within 30 days | Occurrence of other post-operative complications |
| Number of adverse reactions to treatments for Surgical Site Infections | Within 30 days | Adverse reactions to antibiotics given or to dressings use |
| Wound dressings - use of | Up to day 30-40 | Time to discontinuation of dressings, type and number of dressings used |
| 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 |
| Ninety day readmission rate | Up to day 90 | Rate of readmission within 90 days |
| Cause of death | Up to day 90 | Cause of death for any mortalities within 90 days |
| 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 |
| 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 |
| 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 |
Outcome results
None listed