Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000550808
Ethics application status
Not yet submitted
Date submitted
26/03/2012
Date registered
24/05/2012
Date last updated
24/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of negative wound therapy to treat surgical incisions after hip arthroplasty: a pilot study
Scientific title
Pilot study of negative pressure wound dressing therapy versus standard care dressing to prevent surgical site infection in patient undergoing hip arthroplasty
Secondary ID [1] 280219 0
Nil
Universal Trial Number (UTN)
U1111-1129-4755
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Using negative therapy wound dressing to prevent surgical site infections in patients undergoing hip arthroplasty 286155 0
Wounds complications 286164 0
Condition category
Condition code
Surgery 286402 286402 0 0
Surgical techniques
Musculoskeletal 286403 286403 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
At the completion of skin closure, participants allocated to Negative pressure wound therapy (NPWT) will have a PICO (Smith* & Nephew) applied under sterile conditions. The dressing is comprised of a four-layer dressing technology to manage fluid, a dressing is connected to a PICO pump which generates a negative pressure of -80mmHg and removes the exudate from the wound bed through absorbency and evaporation onto the dressing. The dressing will remain in place for 4 days, unless it becomes soiled or dislodged. If this occurs, the dressing will be changed using aseptic technique.

All participants (both intervention and control groups). will receive prophylactic antibiotics intraoperatively, Cefazolin 1 gram intravenously will be adminstered. All other aspects of their care will be consistent between the groups.
Intervention code [1] 284547 0
Prevention
Intervention code [2] 284587 0
Treatment: Other
Intervention code [3] 284735 0
Treatment: Drugs
Comparator / control treatment
Participants in the control arm will have a standard dressing (Primapore Smith* & Nephew) applied per manufacturer's recommendations at the completion of skin closure. Like the NPWT, the dressing will remain in place for 4 days, unless it becomes soiled or dislodged.

All participants (both intervention and control groups). will receive prophylactic antibiotics. All other aspects of their care will be consistent between the groups.
Control group
Active

Outcomes
Primary outcome [1] 286853 0
Presence of surgical site infection (SSI)

Presence of SSI will be assessed by visual inspection and /or through an aseptically obtained culture. Superficial SSI will be identified by at least one of the following signs; purulent discharge, organisms idetified through an aseptically obtained culture, pain/tenderness/ localised swelling/ heat, or a diagnosis of SSI by the consulting surgeon. A deep incisional SSI will be identified by one of the following; purulent discharge, wound dehiscence, abscess formation, or diagnosis of SSI by the treating surgeon.
Timepoint [1] 286853 0
Daily for the period of hospitalisation and then via telephone interview at 28 days post -surgery follow-up and lastly at 6 weeks appointment at outpatient department.
Secondary outcome [1] 296724 0
Wound complications including dehiscence, haematoma and seroma will be assessed by visual inspection.
Timepoint [1] 296724 0
Daily for the period of hospitalisation and then via telephone interview at 28 days post -surgery follow-up and lastly at 6 weeks appointment at outpatient department.
Secondary outcome [2] 296725 0
hospital readmission
Timepoint [2] 296725 0
Daily for the period of hospitalisation and then via telephone interview at 28 days post -surgery follow-up and lastly at 6 weeks appointment at outpatient department.

Eligibility
Key inclusion criteria
1) Signed consent
2) Patients aged 18 years and above
3) Booked for primary hip arthroplasty
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Existing infection
2) Previous participation in this trial
3) Unable to speak or write English with no interpreter present.

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)
All eligible participants will be approached by for written consent by a research assistant during their final preoperative appointment. When the consenting patient presents for surgery, a staff member will ring a telephone based randomisation service customised for this trial and be advised of group allocation.


A computer generated allocated randomisation service is provided by an independent randomisation service. Allocation is fully concealed until the patient is randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomised to the two study group in a 1:1 ratio, using a simple randomisation stratified by hospital.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284971 0
University
Name [1] 284971 0
National Health and Medical Research Council Centre of Research Excellence in Nursing Interventions for Hospitalised Patients (NCREN)
Country [1] 284971 0
Australia
Primary sponsor type
University
Name
National Health and Medical Research Council Centre of Research Excellence in Nursing Interventions for Hospitalised Patients (NCREN)
Address
Griffith University
Clinical Science Building 2
Parkland Drive,
Southport,
Queensland
4222
Country
Australia
Secondary sponsor category [1] 283838 0
None
Name [1] 283838 0
NA
Address [1] 283838 0
NA
Country [1] 283838 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 286977 0
Gold Coast Health service District Research Ethics Committee
Ethics committee address [1] 286977 0
Research Governance Officer
Gold Coast Health Services District
10 Little High St,
Southport
Qld 4215
Ethics committee country [1] 286977 0
Australia
Date submitted for ethics approval [1] 286977 0
30/04/2012
Approval date [1] 286977 0
Ethics approval number [1] 286977 0

Summary
Brief summary
Wounds that fail to heal may cause distress to patients and impact negatively on the physical, social, economic aspects of their life. Wound complications also add to the cost of health care, with clinical comsumables responsible for a large proportion of health care budget. NPWT is based on a therapy on a closed sealed system that produces negative pressure to wound surface. The wound is covered or packed with an open-cell foam or gauze dressings and sealed with an occlusive drape. Intermittent or continuous suction is maintained by connecting suction tubes from the wound dressing to a vacuum pump and liquid waste colelctor. NPWT is growing in use as a prophylactic approach to prevent wound complications especially SSI, yet evidence of its benefits is lacking.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33877 0
Address 33877 0
Country 33877 0
Phone 33877 0
Fax 33877 0
Email 33877 0
Contact person for public queries
Name 17124 0
Dr Brigid Gillespie
Address 17124 0
Griffith University
Gold Coast Campus
G16_Rm 2.63 , CLinical Science Building 2
Southport
Qld 4222
Country 17124 0
Australia
Phone 17124 0
+61 7 55529718
Fax 17124 0
+61 7 5552 8526
Email 17124 0
b.gillespie@griffith.edu.au
Contact person for scientific queries
Name 8052 0
Dr Brigid Gillespie
Address 8052 0
Griffith University
Gold Coast Campus
G16_Rm 2.63 , CLinical Science Building 2
Southport
Qld 4222
Country 8052 0
Australia
Phone 8052 0
+61 7 55529718
Fax 8052 0
Email 8052 0
b.gillespie@griffith.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseNegative pressure wound therapy for surgical wounds healing by primary closure.2019https://dx.doi.org/10.1002/14651858.CD009261.pub4
EmbaseUse of Negative-Pressure Wound Dressings to Prevent Surgical Site Complications after Primary Hip Arthroplasty: A Pilot RCT.2015https://dx.doi.org/10.1177/1553350615573583
N.B. These documents automatically identified may not have been verified by the study sponsor.