ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12612000171819

Ethics application status

Approved

Date submitted

24/01/2012

Date registered

7/02/2012

Date last updated

26/05/2014

Type of registration

Prospectively registered

Titles & IDs

Public title

ADding negative pRESSure to improve healING in obese women undergoing caesarean section (The DRESSING Trial)

Scientific title

Randomised controlled trial of negative pressure wound therapy versus standard care to prevent surgical site infections in obese women undergoing caesarean section: The DRESSING Trial

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1127-3701

Trial acronym

The DRESSING Trial

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Using negative pressure wound therapy to prevent surgical site infections in obese women following caesarean section

Condition category

Condition code

Public Health

Health service research

Reproductive Health and Childbirth

Childbirth and postnatal care

Surgery

Other surgery

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

At the completion of skin closure, those women randomly allocated to the Negative Pressure Wound Therapy (NPWT) will have a PICO Trademark (Smith and Nephew) applied. The gauze based dressing will be secured over the incision with fixation strips and continuous negative pressure of 80mm Hg will be delivered via a tube embedded into the gauze by a small portable battery operated device. The dressing will remain in place for 4 days, unless it becomes soiled or dislodged. If this occurrs the dressing will be changed using aseptic technique. All women (both intervention and control groups) will receive prophylactic antibiotics. All other aspects of their care will be consistent between the groups.

Intervention code [1]

Prevention

Intervention code [2]

Treatment: Other

Comparator / control treatment

Women in the control arm will have a standard dressing (Comfeel Plus (Coloplast) applied per manaufacturer's recommendations at the completion of skin closure. Like the NPWT dressing, the standard dressing will remain in place for 4 days, unless it becomes soiled or dislodged. All women (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 identified 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 1, 2, 3 and 4 week post-surgery follow-up

Secondary outcome [1]

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

Timepoint [1]

Daily for period of hospitalisation and then via telephone interview at 1, 2, 3 and 4 week post-surgery follow-up

Secondary outcome [2]

self-reported incisional pain in the 2 days after caesarean surgery

Timepoint [2]

daily for two days post surgery

Secondary outcome [3]

hospital readmissions

Timepoint [3]

at four weeks post surgery

Secondary outcome [4]

hospital length of stay

Timepoint [4]

at four weeks post surgery

Secondary outcome [5]

Health-related quality of life (QOL) using SF-12

Timepoint [5]

at baseline i.e. on recruitment at 36 weeks, and via telephone interview at 1, 2, 3 and 4 week post-surgery follow-up

Eligibility

Key inclusion criteria

(i) informed written informed consent
(ii) recorded Body Mass Index (BMI) of equal to or greater than 30kg/m2 at the first antenatal visit as per the Queensland Maternity
and Neonatal Clinical Guideline 2010
(iii) booked for elective CS surgery (before the commencement of labour)

Minimum age

No limit

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

(i) Non-English speaking patients without interpreter
(ii) existing infection
(iii) Previous participation in this trial

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 women (or their representative) will be approached for written informed consent by a Research Assistant (Registered Midwife or Registered Nurse) during their final antenatal outpatient appointment. When the consenting patient presents for surgery, a staff member will access a web-based randomisation service customised for this trial and be advised of group allocation. Computer generated allocation 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)

Computer generated. Participants will be randomised to the two study groups in a 1:1 ratio, using 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

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/03/2012

Actual

26/06/2012

Date of last participant enrolment

Anticipated

Actual

3/04/2014

Date of last data collection

Anticipated

Actual

Sample size

Target

100

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment postcode(s) [1]

4215

Recruitment postcode(s) [2]

4029

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Office of Health and Medical Research

Address [1]

Level 13, Queensland Health Building
147-163 Charlotte Street
Brisbane
Qld 4000

Country [1]

Australia

Primary sponsor type

University

Name

NHMRC Centre of Research Excellence in Nursing Interventions for Hospitalised Patients, Griffith University

Address

Clinical Sciences Building 2
Parklands Drive
Southport
Queensland 4222

Country

Australia

Secondary sponsor category [1]

None

Name [1]

N/A

Address [1]

N/A

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Gold Coast Hospital and Health Service Human Ethics Committee

Ethics committee address [1]

Gold Coast Hospital
108 Nerang Street
Southport
Queensland 4215

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/02/2012

Approval date [1]

20/04/2012

Ethics approval number [1]

HREC/12/QGC/29

Ethics committee name [2]

Griffith University Human Research Ethics Committee

Ethics committee address [2]

Gold Coast Campus
Room 3.60, Science, Engineering and Architecture (G39)
Griffith University
Parklands
Qld 4222

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

16/05/2012

Ethics approval number [2]

GU Ref No. NRS/17/12/HREC

Summary

Brief summary

Obesity is a growing global public health problem in developed nations. It is estimated that half of all Australian women of childbearing age are overweight or obese. Obese pregnant women are more likely to deliver their babies by Caesarean Section and are also more likely to have complications such as Surgical Site Infections after Caesarean Section than non-obese women. 

Wounds that fail to heal may cause considerable distress to patients and negatively affect the physical, social, emotional and economic aspects of their life. Wound complications also add to the cost of health care. 

Negative Pressure Wound Therapy has been used to aid healing since it was first developed in the late 1990s.  The treatment is based on a closed sealed system that produces negative pressure to the wound surface. The wound is covered and sealed with an occlusive dressing and suction tubes which are connected to a vacuum pump which provides intermittent or continuous suction.  Negative Pressure Wound Therapy is being used more frequently as a way to prevent wound complications especially Surgical Site Infections, but it has not been well tested yet. 

This study will test the effectiveness of two different methods to dress surgical wounds following Caesarean Section.  These include Negative Pressure Wound Therapy compared to current care (standard dressing).  We are doing this research study to find out the best practice for preventing Surgical Site Infections in obese women.   To do this, we need to study women with a Body Mass Index (BMI) greater than or equal to 30 for one month following their surgery, and closely monitor their surgical wound

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Wendy Chaboyer

Address

NHMRC Research Centre for Clinical Excellance in Nursing Interventions for Hospitalised Patients, Griffith University, Gold Coast Campus, Clinical Sciences Building 2, Parklands Drive, Southport Queensland 4215

Country

Australia

Phone

+61 7 5552 8518

Fax

+61 7 5552 8528

w.chaboyer@griffith.edu.au

Contact person for public queries

Name

Professor Wendy Chaboyer

Address

NHMRC Research Centre for Clinical Excellence in Nursing Interventions for Hospitalised Patients,
Griffith University
Gold Coast Campus
Clinical Sciences Building 2
Parklands Drive
Southport
Queensland 4215

Country

Australia

Phone

+61 7 5552 8518

Fax

+61 7 5552 8528

w.chaboyer@griffith.edu.au

Contact person for scientific queries

Name

Professor Wendy Chaboyer

Address

Country

Australia

Phone

+61 7 5552 8518

Fax

+61 7 5552 8528

w.chaboyer@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	Cost-effectiveness analysis alongside a pilot study of prophylactic negative pressure wound therapy.	2017	https://dx.doi.org/10.1016/j.jtv.2016.06.001

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

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically