Clinical trial NCT04110353: Prophylactic Closed Incision Negative Pressure Wound Therapy on Abdominal Wounds - Clinical and Economic Perspectives
Official title: Prophylactic Closed Incision Negative Pressure Wound Therapy on Abdominal Wounds - Clinical and Economic Perspectives: A Multi-centre Randomised Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Wound Infection
Surgical Site Infection
Surgical Wound
Surgical Incision
Keywords: Surgical Site infections
Negative Pressure Wound Therapy
Contaminated abdominal wounds
Closed incision abdominal wound
Prophylactic therapy
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped wedge design with randomisation at the level of the Hospitals not individual patients
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Surgical Site Infection
timeFrame: Up to day 90
Secondary outcomes:
measure: Wound assessments - clinical assessment of presence of wound complication and healing
timeFrame: At day 7 (on removal of dressing), up to day 30 (on discharge), day 40 (at outpatient follow up)
measure: Length of stay
timeFrame: Up to 90 days
measure: Number of additional interventions received by participants due to development of a Surgical Site Infection
timeFrame: Within 30 days
measure: Microscopy, culture and sensitivity results from swabs of any Surgical Site Infections
timeFrame: Within 30 days
measure: Post operative complications - other
timeFrame: Within 30 days
measure: Number of adverse reactions to treatments for Surgical Site Infections
timeFrame: Within 30 days
measure: Wound dressings - use of
timeFrame: Up to day 30-40
measure: Ninety day mortality rate
timeFrame: Up to day 90
measure: Ninety day readmission rate
timeFrame: Up to day 90
measure: Cause of death
timeFrame: Up to day 90
measure: Quality of life measures: EuroQol 5 Dimensions 5 Levels (EQ5D5L) questionnaire
timeFrame: At day 7 (on removal of dressing), up to day 30 (on discharge), day 40 (at outpatient follow up)
measure: Quality of life measures: Wound Quality of Life questionnaires
timeFrame: At day 7 (on removal of dressing), up to day 30 (on discharge), day 40 (at outpatient follow up)
measure: Quality of life and economic measures: Economic assessment questionnaire
timeFrame: At day 40
measure: Long term follow up - Hernia occurrence
timeFrame: At 1, 3 and 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Imperial College London
name: Christopher Peters
role: PRINCIPAL_INVESTIGATOR
affiliation: St Mark's Hospital and Academic Institute
name: Carolynne Vaizey
role: STUDY_CHAIR
References: