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Trial registered on ANZCTR


Registration number
ACTRN12615000175572
Ethics application status
Approved
Date submitted
25/11/2014
Date registered
23/02/2015
Date last updated
8/09/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Do suction assisted negative pressure dressings reduce the incidence of surgical site infections after abdominal surgery: a randomized controlled trial.
Scientific title
Do suction assisted negative pressure dressings(NPD) reduce the incidence of surgical site infections after clean/contaminated abdominal surgery: a randomized controlled trial.
Secondary ID [1] 285695 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Laparotomy wound infection 293552 0
Condition category
Condition code
Infection 293834 293834 0 0
Studies of infection and infectious agents
Surgery 294016 294016 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Negative-pressure wound dressing by Smith & Nephew called PICO.
PICO is a pocket sized portable device attached to laparotomy wound dressing via a long thin tubing.
The device is left switched on for 7 consecutive days with no further dressing change required. A negative pressure milieu of 80 mmHg (nominal) +/- 20 mmHg is applied to the wound surface.
Intervention code [1] 290692 0
Treatment: Devices
Comparator / control treatment
Standard dressing used with a clear film with an absorbent layer (Opsite Post Op).
Control group
Active

Outcomes
Primary outcome [1] 293687 0
Wound infection - Definition based on definitions published by VICNISS, the major healthcare infection surveillance organisation for Victoria. This outcome is assesed by our research/stoma Nurses at Dandenong Hospital on day 7(up to day9) of having had surgery
Timepoint [1] 293687 0
7 days
Secondary outcome [1] 311594 0
Patient satisfaction. Measured with satisfaction questionnaire on various aspect of patient's experience of his/her wound dressing. Satisfaction level graded on a linear scale from 1- to 10. This is completed over the phone at day 30 by researcher
Timepoint [1] 311594 0
30 days

Eligibility
Key inclusion criteria
* Patients undergoing laparotomy (where abdominal incision breaches peritoneum, and wound is large enough at least to fit the surgeons’ hand); and
* High risk for SSI, with one or more of the following risk factors:
* Obesity (BMI > 30)
* Contaminated surgery (perforation or abscess)
* Semi emergency clean/contaminated surgery (where surgery may be safely delayed up to 24 hours)
* Are able to read English, or have the consent form translated for them
* Are able to provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Mini laparotomy
* Elective clean surgery (Right Hemi colectomy, Anterior resection)
* Emergency ‘clean’ surgery, e.g. adhesiolysis, hernia repair, wound dehiscence
* Relook surgery
* Pregnant patients
* Patients under 18 years of age
* Patients who are unwilling or unable to consent
* Patient too sick to give informed consent- e.g. sepsis, or requiring urgent surgery within 24 hours of presentation to hospital

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
a sealed enveloped containing intervention procedure and study number to be opened, after informed consent and signature obtained
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sheet
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size was determined to be 160 patients. This is based on
Power calculation for Superiority Trial. we estimated number of SSI with conventional wound dressing is 20%, Estimated number of SSI with PICO dressing is 5%. Using Power 80%, alpha 0.05, number of patients per arm required is 73 patients. We allow for dropouts and other events, so 80 patients per arm was derived.

Data will be analysed on an intention to treat basis
Number of SSI’s will be compared between the two groups, using Pearson’s Chi Squared test. Relative risk and absolute risk reduction will be calculated, and if there is a benefit to PICO, the number needed to treat.
Risk factors will be analysed with appropriate statistical tools including Chi square, fisher’s exact, univariate/multivariate analysis, student’s (unpaired) t-test
2 tailed p values will be calculated, with a value <0.05 considered statistically significant

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/02/2015
Actual
23/03/2015
Date of last participant enrolment
Anticipated
30/07/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3210 0
Dandenong Hospital - Dandenong
Recruitment postcode(s) [1] 8989 0
3175 - Dandenong

Funding & Sponsors
Funding source category [1] 290309 0
Other Collaborative groups
Name [1] 290309 0
Smith and Nephew Medical Ltd
Country [1] 290309 0
United Kingdom
Primary sponsor type
Hospital
Name
Dandenong Campus, Monash Health
Address
Dandenong Campus
Monash Health
135 David Street
Dandenong
Victoria 3175
Country
Australia
Secondary sponsor category [1] 289020 0
Individual
Name [1] 289020 0
P.Y Tan
Address [1] 289020 0
Dandenong Campus
Monash Health
135 David Street
Dandenong
Victoria 3175
Country [1] 289020 0
Australia
Secondary sponsor category [2] 289021 0
Individual
Name [2] 289021 0
J Flynn
Address [2] 289021 0
Dandenong Campus
Monash Health
135 David Street
Dandenong
Victoria 3175
Country [2] 289021 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292015 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 292015 0
Address for HREC manager, Ms Deborah Dell:
Research Support Services
Monash Health
Level 2, I Block,
Monash Medical Centre,
Clayton, 3168
Victoria
Ethics committee country [1] 292015 0
Australia
Date submitted for ethics approval [1] 292015 0
02/07/2014
Approval date [1] 292015 0
26/11/2014
Ethics approval number [1] 292015 0
14236B

Summary
Brief summary
The aim of this project is to assess a new kind of dressing, to see whether it reduces the rate of wound infections after abdominal surgery. The dressing is attached to a small, portable device that creates suction or negative pressure on the wound, to help suck away any fluid that leaks from the wound.
These dressings have been assessed as being safe, and are already in use in the hospital. However, there is no conclusive evidence that they provide a benefit to patients by reducing wound infections.

We will hopefully answer that question, and help to provide better outcomes to future patients undergoing abdominal surgery.
This study is in part funded by the company that makes the dressing used. However, they do not provide any direct payment to the investigators, and do not have any role in collecting information or deciding what the results of the study are.
This research is being conducted by doctors and nurses working in Dandenong Hospital, under the auspices of the Monash School of Medicine.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 252 252 0 0
/AnzctrAttachments/367454-Participant Information Sheet & Consent Form.doc
Attachments [2] 253 253 0 0
/AnzctrAttachments/367454-HREC & SSA Approval Letter.PDF

Contacts
Principal investigator
Name 52874 0
Mr P.Y Tan
Address 52874 0
Dandenong Campus
Monash Health
135 David Street
Dandenong
Victoria 3175
Country 52874 0
Australia
Phone 52874 0
61 03 95541000
Fax 52874 0
Email 52874 0
[email protected]
Contact person for public queries
Name 52875 0
Julie Flynn
Address 52875 0
Dandenong Campus
Monash Health
135 David Street
Dandenong
Victoria 3175
Country 52875 0
Australia
Phone 52875 0
61 03 95541000
Fax 52875 0
Email 52875 0
[email protected]
Contact person for scientific queries
Name 52876 0
Julie Flynn
Address 52876 0
Dandenong Campus
Monash Health
135 David Street
Dandenong
Victoria 3175
Country 52876 0
Australia
Phone 52876 0
61 03 95541000
Fax 52876 0
Email 52876 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
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