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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] 279765 0
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 285634 0
Condition category
Condition code
Public Health 285823 285823 0 0
Health service research
Reproductive Health and Childbirth 285897 285897 0 0
Childbirth and postnatal care
Surgery 285898 285898 0 0
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] 284086 0
Prevention
Intervention code [2] 284152 0
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] 286336 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 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] 286336 0
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] 295626 0
Wound complications including dehiscence, haematoma and seroma will be assessed by visual inspection
Timepoint [1] 295626 0
Daily for period of hospitalisation and then via telephone interview at 1, 2, 3 and 4 week post-surgery follow-up
Secondary outcome [2] 295627 0
self-reported incisional pain in the 2 days after caesarean surgery
Timepoint [2] 295627 0
daily for two days post surgery
Secondary outcome [3] 295628 0
hospital readmissions
Timepoint [3] 295628 0
at four weeks post surgery
Secondary outcome [4] 295629 0
hospital length of stay
Timepoint [4] 295629 0
at four weeks post surgery
Secondary outcome [5] 295630 0
Health-related quality of life (QOL) using SF-12
Timepoint [5] 295630 0
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
Gender
Females
Can healthy volunteers participate?
No
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
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)
Recruitment postcode(s) [1] 4869 0
4029
Recruitment postcode(s) [2] 4868 0
4215

Funding & Sponsors
Funding source category [1] 286868 0
Government body
Name [1] 286868 0
Office of Health and Medical Research
Address [1] 286868 0
Level 13, Queensland Health Building
147-163 Charlotte Street
Brisbane
Qld 4000
Country [1] 286868 0
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] 283483 0
None
Name [1] 283483 0
N/A
Address [1] 283483 0
N/A
Country [1] 283483 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286552 0
Gold Coast Hospital and Health Service Human Ethics Committee
Ethics committee address [1] 286552 0
Gold Coast Hospital
108 Nerang Street
Southport
Queensland 4215
Ethics committee country [1] 286552 0
Australia
Date submitted for ethics approval [1] 286552 0
22/02/2012
Approval date [1] 286552 0
20/04/2012
Ethics approval number [1] 286552 0
HREC/12/QGC/29
Ethics committee name [2] 288929 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 288929 0
Gold Coast Campus
Room 3.60, Science, Engineering and Architecture (G39)
Griffith University
Parklands
Qld 4222
Ethics committee country [2] 288929 0
Australia
Date submitted for ethics approval [2] 288929 0
Approval date [2] 288929 0
16/05/2012
Ethics approval number [2] 288929 0
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 33660 0
Prof Wendy Chaboyer
Address 33660 0
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 33660 0
Australia
Phone 33660 0
+61 7 5552 8518
Fax 33660 0
+61 7 5552 8528
Email 33660 0
w.chaboyer@griffith.edu.au
Contact person for public queries
Name 16907 0
Prof Professor Wendy Chaboyer
Address 16907 0
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 16907 0
Australia
Phone 16907 0
+61 7 5552 8518
Fax 16907 0
+61 7 5552 8528
Email 16907 0
w.chaboyer@griffith.edu.au
Contact person for scientific queries
Name 7835 0
Prof Professor Wendy Chaboyer
Address 7835 0
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 7835 0
Australia
Phone 7835 0
+61 7 5552 8518
Fax 7835 0
+61 7 5552 8528
Email 7835 0
w.chaboyer@griffith.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary