ANZCTR - Registration

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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]

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

Wounds complications

Condition category

Condition code

Surgery

Surgical techniques

Musculoskeletal

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]

Prevention

Intervention code [2]

Treatment: Other

Intervention code [3]

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]

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]

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]

Wound complications including dehiscence, haematoma and seroma will be assessed by visual inspection.

Timepoint [1]

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]

hospital readmission

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

National Health and Medical Research Council Centre of Research Excellence in Nursing Interventions for Hospitalised Patients (NCREN)

Address [1]

Griffith University
Clinical Science Building 2
Parkland Drive,
Southport,
Queensland
4222

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Gold Coast Health service District Research Ethics Committee

Ethics committee address [1]

Research Governance Officer
Gold Coast Health Services District
10 Little High St,
Southport
Qld 4215

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/04/2012

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Brigid Gillespie

Address

Griffith University
Gold Coast Campus
G16_Rm 2.63 , CLinical Science Building 2
Southport
Qld 4222

Country

Australia

Phone

+61 7 55529718

Fax

+61 7 5552 8526

b.gillespie@griffith.edu.au

Contact person for scientific queries

Name

Dr Brigid Gillespie

Address

Griffith University
Gold Coast Campus
G16_Rm 2.63 , CLinical Science Building 2
Southport
Qld 4222

Country

Australia

Phone

+61 7 55529718

Fax

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

Source	Title	Year of Publication	DOI
Embase	Use of Negative-Pressure Wound Dressings to Prevent Surgical Site Complications after Primary Hip Arthroplasty: A Pilot RCT.	2015	https://dx.doi.org/10.1177/1553350615573583
Embase	Negative pressure wound therapy for surgical wounds healing by primary closure.	2019	https://dx.doi.org/10.1002/14651858.CD009261.pub4

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically