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Trial registered on ANZCTR


Registration number
ACTRN12619000213145
Ethics application status
Approved
Date submitted
1/02/2019
Date registered
14/02/2019
Date last updated
4/02/2020
Date data sharing statement initially provided
14/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Prophylactic negative pressure wound therapy for reduction of surgical site infection in high-risk women undergoing open abdominal surgery: A quality improvement project
Scientific title
Prophylactic negative pressure wound therapy for reduction of surgical site infection in high-risk women undergoing open abdominal surgery: A quality improvement project
Secondary ID [1] 297271 0
None
Universal Trial Number (UTN)
U1111-1220-0307
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical wound infection 311344 0
Condition category
Condition code
Surgery 309981 309981 0 0
Surgical techniques
Infection 310004 310004 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Prophylactic use of the Smith & Nephew PICO negative pressure wound therapy system following open obstetric and gynaecological abdominal surgery in patients deemed high risk for developing surgical wound infection by the following criteria:

- Body mass index greater than or equal to 40 or
- Body mass index less than 40 plus two or more of the following risk factors: Diabetes, Steroids or Anticoagulants in the last 48 hours, Autoimmune disorders, Blood or haematological disorders, Immunosuppressant medication, Hypertensive disorders, Multiple laparotomies greater than or equal to 3, Previous wound infections, Pre-existing skin problems, Premature Rupture of Membranes, Preterm Premature Rupture of Membranes with Chorioamnionitis, Suspected or confirmed Chorioamnionitis, Prolonged labour with rupture of membranes and fetal scalp electrode.

Medical records of patients readmitted to hospital with surgical wound infection within 30 days of primary open obstetric and gynaecological abdominal surgery will be reviewed retrospectively from 1 January 2018 to 31 August 2019, excluding a washout period from 1 September 2018 to 31 December 2018 during which the Smith & Nephew PICO negative pressure wound therapy system was introduced. i.e. data from 1 Jan 2019 to 31 Aug 2019 is the exposure of interest and will be compared to data from the previous period from 1 Jan 2018 - 31 Aug 2018 before negative pressure wound therapy was in use.

The total population analysed will consist of approximately 2900 women, but only a high risk (approximately 20%) subset should receive the Smith & Nephew PICO negative pressure wound therapy system. The PICO dressing will be placed by the surgeon at the conclusion of the abdominal component of each operation.
Intervention code [1] 313627 0
Not applicable
Comparator / control treatment
Patients readmitted to hospital with surgical wound infection within 30 days of primary open obstetric and gynaecological abdominal surgery performed 1 Jan 2018 to 31 Aug 2018 (prior to implementation of use of the Smith & Nephew PICO negative pressure wound therapy system in high risk individuals instead of standard OpSite wound dressings).

Data will be obtained from written and electronic clinical records obtained from Counties Manukau Health.
Control group
Historical

Outcomes
Primary outcome [1] 318896 0
Hospital readmission with surgical site infection (SSI) as assessed by data linkage to medical records. SSI is defined per the internationally accepted modified CDC definitions of nosocomial surgical site infections.
Timepoint [1] 318896 0
Within 30 days of primary surgery.
Secondary outcome [1] 366361 0
Return to the operating theatre as assessed by data linkage to medical records.
Timepoint [1] 366361 0
Within 30 days of primary surgery.
Secondary outcome [2] 366362 0
Minimally invasive radiological interventions as assessed by data linkage to medical records.
Timepoint [2] 366362 0
Within 30 days of primary surgery.
Secondary outcome [3] 366363 0
Treatment with antibiotics as assessed by data linkage to medical records.
Timepoint [3] 366363 0
Within 30 days of primary surgery.

Eligibility
Key inclusion criteria
All women undergoing open abdominal surgery where the responsible clinician is an obstetrician or gynaecologist at Counties Manukau Health (CMH) from 1 January 2018 to 31 August 2019, excluding a washout period from 1 September 2018 to 31 December 2018.
Minimum age
5 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women whose primary surgery was performed outside Women’s Health CMH are excluded.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Consecutive block samples by month will be used to produce a run chart, to determine if a reduction in hospital readmissions with surgical site infection can be identified following introduction of the Smith & Nephew PICO negative pressure wound therapy system.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2019
Actual
1/03/2019
Date of last participant enrolment
Anticipated
31/08/2019
Actual
31/08/2019
Date of last data collection
Anticipated
30/09/2019
Actual
31/10/2019
Sample size
Target
2900
Accrual to date
Final
3056
Recruitment outside Australia
Country [1] 21241 0
New Zealand
State/province [1] 21241 0

Funding & Sponsors
Funding source category [1] 301831 0
Government body
Name [1] 301831 0
Counties Manukau Health
Country [1] 301831 0
New Zealand
Primary sponsor type
Government body
Name
Counties Manukau Health
Address
Middlemore Hospital
Private Bag 93311
Otahuhu
Auckland 1640
Country
New Zealand
Secondary sponsor category [1] 301576 0
None
Name [1] 301576 0
Address [1] 301576 0
Country [1] 301576 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302533 0
Health and Disability Ethics Committees
Ethics committee address [1] 302533 0
Ethics committee country [1] 302533 0
New Zealand
Date submitted for ethics approval [1] 302533 0
Approval date [1] 302533 0
31/01/2019
Ethics approval number [1] 302533 0
18/CEN/277

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90550 0
Dr Sam Holford
Address 90550 0
Middlemore Hospital
Private Bag 93311
Otahuhu
Auckland 1640
Country 90550 0
New Zealand
Phone 90550 0
+64 21 673 189
Fax 90550 0
Email 90550 0
samholford@gmail.com
Contact person for public queries
Name 90551 0
Sam Holford
Address 90551 0
Middlemore Hospital
Private Bag 93311
Otahuhu
Auckland 1640
Country 90551 0
New Zealand
Phone 90551 0
+64 21 673 189
Fax 90551 0
Email 90551 0
samholford@gmail.com
Contact person for scientific queries
Name 90552 0
Sam Holford
Address 90552 0
Middlemore Hospital
Private Bag 93311
Otahuhu
Auckland 1640
Country 90552 0
New Zealand
Phone 90552 0
+64 21 673 189
Fax 90552 0
Email 90552 0
samholford@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Confidentiality.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1271Ethical approval    376873-(Uploaded-01-02-2019-12-00-01)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.