Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001611213p
Ethics application status
Not yet submitted
Date submitted
3/09/2018
Date registered
28/09/2018
Date last updated
28/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the use of negative pressure wound therapy reduce the rate of post operative wound infection after bowel surgery
Scientific title

The effect of PICO dressings on surgical site infection following bowel resection: A randomised controlled trial
Secondary ID [1] 295687 0
none
Universal Trial Number (UTN)
U1111-1218-2739
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical site infection after bowel resection
 309061 0
Condition category
Condition code
Infection 307945 307945 0 0
Other infectious diseases
Surgery 308523 308523 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A PICO dressing is a type of negative pressure wound therapy dressing. The intervention will involve the application of a PICO dressing to the main surgical wound with reinforcement of the wound edges using adhesive tape supplied with dressing. Dressing should be left on for 5 days. Then replaced with simple dressings. If a PICO loses suction and cannot be reinforced to regain suction prior to 5 days, it can be replaced with another PICO dressing. The PICO can be replaced once, thereafter regular dressing will be used (patients will be analysed with an intention to treat analysis) All surgeons will be educated with the proper application of the PICO dressing prior to commencement of the study.
Adherence to the use of PICO dressings will be monitored by the researchers involved with the study by daily checks of the notes and interaction with patients.
Intervention code [1] 302005 0
Treatment: Devices
Comparator / control treatment
Application of a dressing, to the preference of the operating surgeon. Dressings to be changed at the discretion of the team / nursing staff.
The control group treatment is considered 'usual care'. This is not based upon specific guidelines, but upon surgeon preference. We do not have knowledge of a specific adhesive dressing which has significant advantage over other types of dressing.
Control group
Active

Outcomes
Primary outcome [1] 306918 0

Surgical Site Infection (SSI) is defined by the Center for Disease Control and Prevention (CDC) criteria as follows:
Infection occurring within the first 30 post-operative days with at least one of the following:
• Purulent drainage from the incision
• Organisms isolated from an aseptically obtained culture of fluid or tissue from the incision
• The incision is deliberately opened by a surgeon AND the patient has at least one of the following signs/symptoms of infection: Pain or tenderness, localized swelling, redness, heat
• Diagnosis of SSI by a doctor.

This information will be gained by the researchers through review of patient records and patient in a prospective manner with a proforma.
Timepoint [1] 306918 0
The presence of SSI will be assessed every day following dressing removal until discharge, at routine clinic follow up (usually at 3 weeks post op), at 30 days following the operation through a structured telephone interview/clinic appointment, or at any time during the study period if the participant or surgical team has concerns about the development of an SSI in the incision.
The primary endpoint of the study is 30 days.
Secondary outcome [1] 350105 0
Length of stay - this will be assessed through the hospital records
Timepoint [1] 350105 0
This will be assessed as the time from admission to first discharge in days
Secondary outcome [2] 350106 0
cost-benefit analysis. This is planned to be a basic cost analysis with calculation of the use of antibiotics, estimated costs of readmission for wound infection, GP visits, district nurse cares. This information will be collated through the hospital records as well as structured questionnaires administered at the primary end point of 30 days. These questionnaires have been designed specifically for data collection for this study.
Timepoint [2] 350106 0
This will be assessed at 30 days post surgery
Secondary outcome [3] 350107 0
participant satisfaction survey - simple score 1 to 10 for two questions - "overall satisfaction with wound appearance" and "overall satisfaction with dressings". These two questions were specifically designed for this study.
Timepoint [3] 350107 0
30 days post surgery
Secondary outcome [4] 352208 0
Patient and Observer Scar Assessment Scale (POSAS) which is a validated scoring system for scar assessment. (Draaijers LJ, Tempelman FRH, Botman YAM, Tuinebreijer WE, Middelkoop E, Kreis RW, et al. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960–5; discussion 1966-1967. )
Timepoint [4] 352208 0
30 days post surgery

Eligibility
Key inclusion criteria
• All adults (aged 18 and over) undergoing elective or emergency small or large bowel resection
• No restrictions are made on the basis of wound classification
• Incision type – abdominal midline laparotomy, hybrid (laparoscopically-assisted) with an extra-corporeal anastamosis, laparoscopic converted to open
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Pregnancy
• Sensitivity or allergy to adhesive materials
• Inability to give informed consent
• Upper gastrointestinal surgery (pancreaticoduodenectomy, Ivor lewis oesophagectomy, bariatric surgery)
• Open abdomen
• Patients undergoing category “P1” emergency surgery

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be done on a 1:1 basis using an online random number generator, with randomization codes placed in a sealed envelope with study ID code stickers and other documentation. The envelopes should be opened in order and only once the wound is closed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation created by computer programme
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size has been calculated using a of 0.05 and ß of 0.2 with a baseline wound infection rate approximated from the literature at 35% and an expected wound infection rate reduction to 10%. Assuming an attrition rate of 10% we will require 56 participants in each group (total 112).

All analysis will be pre-specified and conducted according to the intention-to-treat principle. The proportion of SSIs amongst all participants will be compared between the PICO and adhesive dressing arms using a chi-square test. An absolute risk increase/reduction for SSI will be presented for the use of PICO, as well as the number needed to treat to prevent a single SSI. Participants lost to follow-up will be considered to have developed an SSI for the purposes of primary analysis. Furthermore, despite instructions to contact or return to clinic if any concerns of an SSI arise, any incisions diagnosed or treated for an SSI by any physician will be considered as having had an SSI.

Baseline characteristics of the two groups will be recorded, including body mass index (BMI), self-reported smoking status and co-morbidities. In the event that any of the baseline characteristics are found to differ significantly between the intervention and standard care groups by chance, secondary analyses will be performed using multivariable logistic regression to adjust for the effect of differences in the baseline characteristics on the primary outcome. Results will then be presented as an adjusted odds ratio.

Secondary outcomes will be compared between groups using a chi-square for categorical variables (i.e., need for home care, proportion receiving antibiotics). Non-normally distributed continuous variables (length of hospital stay, duration of home care treatment, number of return visits) will be compared using the Mann-Whitney U-test. A p-value of less than 0.05 will be considered significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2019
Actual
Date of last participant enrolment
Anticipated
27/03/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
112
Accrual to date
Final
Recruitment outside Australia
Country [1] 10710 0
New Zealand
State/province [1] 10710 0
Manawatu

Funding & Sponsors
Funding source category [1] 300270 0
Hospital
Name [1] 300270 0
Palmerston North Hospital
Country [1] 300270 0
New Zealand
Primary sponsor type
Hospital
Name
Palmerston North Hospital
Address
50 Ruahine St, Roslyn, Palmerston North 4442
Country
New Zealand
Secondary sponsor category [1] 299698 0
None
Name [1] 299698 0
Address [1] 299698 0
Country [1] 299698 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 301086 0
Health and Disability Ethics Committee
Ethics committee address [1] 301086 0
Ethics committee country [1] 301086 0
New Zealand
Date submitted for ethics approval [1] 301086 0
25/10/2018
Approval date [1] 301086 0
Ethics approval number [1] 301086 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3107 3107 0 0
/AnzctrAttachments/375694-HDEC application 19 sept.docx

Contacts
Principal investigator
Name 85834 0
Ms Alexandra Gordon
Address 85834 0
Palmerston North Hospital
50 Ruahine St, Roslyn, Palmerston North 4442
Country 85834 0
New Zealand
Phone 85834 0
+646-356 9169
Fax 85834 0
Email 85834 0
[email protected]
Contact person for public queries
Name 85835 0
Alexandra Gordon
Address 85835 0
Palmerston North Hospital
50 Ruahine St, Roslyn, Palmerston North 4442
Country 85835 0
New Zealand
Phone 85835 0
+646-356 9169
Fax 85835 0
Email 85835 0
[email protected]
Contact person for scientific queries
Name 85836 0
Alexandra Gordon
Address 85836 0
Palmerston North Hospital
50 Ruahine St, Roslyn, Palmerston North 4442
Country 85836 0
New Zealand
Phone 85836 0
+646-356 9169
Fax 85836 0
Email 85836 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
No additional documents have been identified.