Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000286549
Ethics application status
Approved
Date submitted
25/02/2015
Date registered
26/03/2015
Date last updated
22/12/2020
Date data sharing statement initially provided
22/12/2020
Date results provided
22/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Adding negative pRESSure to improve healING (the DRESSING trial)
Scientific title
Negative pressure wound therapy versus standard care dressing to prevent surgical site infections in obese women undergoing caesarean section.
Secondary ID [1] 286269 0
NIL
Universal Trial Number (UTN)
U1111-1167-6302
Trial acronym
The DRESSING Trial (RCT)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical site infections in obese women following caesarean section. 294330 0
Condition category
Condition code
Diet and Nutrition 294650 294650 0 0
Obesity
Surgery 294706 294706 0 0
Other surgery
Reproductive Health and Childbirth 294842 294842 0 0
Normal pregnancy

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 80mmHg 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 occurs 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] 291286 0
Prevention
Intervention code [2] 291287 0
Treatment: Devices
Comparator / control treatment
Women in the control arm will have a standard dressing (a hydrocolloid dressing) applied by 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] 294408 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 sign; 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] 294408 0
Day 2 for the period of hospitalisation and then via telephone interview at 1,2,3, and 4 week post-surgery follow-up. A data collection form will be used to collect information on wound assessment during telephone follow-up. These questions will relate to the women's self-assessment of the wound.
Secondary outcome [1] 313222 0
Wound complications including dehiscence, haematoma and seroma will be assessed by visual inspection.
Timepoint [1] 313222 0
Day 2 for the period of hospitalisation and then via telephone interview at 1,2,3, and 4 week post-surgery follow-up. A data collection form will be used to collect information on wound assessment during telephone follow-up. These questions will relate to the women's self-assessment of the wound.
Secondary outcome [2] 313223 0
Hospital readmissions
Timepoint [2] 313223 0
At 4 weeks post surgery.
Secondary outcome [3] 313224 0
Hospital length of stay
Timepoint [3] 313224 0
At four weeks post surgery
Secondary outcome [4] 313225 0
Health related quality of life (QOL) using SF-12
Timepoint [4] 313225 0
At baseline i.e. on recruitment and via telephone interview at 1, 2, 3 and 4 week post-surgery follow-up.

Eligibility
Key inclusion criteria
1. Recorded body mass index (BMI) of equal to or greater than 30kg/m2 at the first antenatal booking visit.
2. Booked for elective caesarean section.
3. Semi-urgent caesarean section (as per treating Specialist).
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous participation in the trial.
2. Being treated for an existing infection with antibiotics after admission and prior to caesarean section.
3. Non-English speaking patients without an interpreter.
4. Clinical suspicion of chorioamnionitis.

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/Registered Nurse) during their final antenatal outpatient appointment. When the consenting woman presents for surgery, a staff member or researh assistant (RA) will access a web-based randomisation service customised for this trial and be advised of group allocation at wound closure. Computer generated allocation is provided by an independent randomisation service. Allocation is fully concealed until the woman is randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated. Women 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
26/10/2015
Actual
26/10/2015
Date of last participant enrolment
Anticipated
3/08/2019
Actual
31/10/2019
Date of last data collection
Anticipated
Actual
2/12/2019
Sample size
Target
2100
Accrual to date
Final
2109
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3517 0
Ipswich Hospital - Ipswich
Recruitment hospital [2] 3518 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [3] 3519 0
Gold Coast Hospital - Southport
Recruitment hospital [4] 3522 0
Mater Mother's Hospital - South Brisbane
Recruitment postcode(s) [1] 9280 0
4305 - Ipswich
Recruitment postcode(s) [2] 9281 0
4215 - Southport
Recruitment postcode(s) [3] 9282 0
4006 - Herston
Recruitment postcode(s) [4] 9283 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 290824 0
Government body
Name [1] 290824 0
National Health & Medical Research Council
Country [1] 290824 0
Australia
Primary sponsor type
University
Name
NHMRC Centre of Resaerch Excellence in Nursing Interventions for Hospitalised Patients, Griffith University
Address
Clinical Science Building 2
Parklands Drive
Southport
Queensland 4222
Australia
Country
Australia
Secondary sponsor category [1] 289511 0
None
Name [1] 289511 0
N/A
Address [1] 289511 0
N/A
Country [1] 289511 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292447 0
Royal Brisbane & Women's Hospital Human Research Ethics Committee (HREC) EC00172
Ethics committee address [1] 292447 0
Ethics committee country [1] 292447 0
Australia
Date submitted for ethics approval [1] 292447 0
30/03/2015
Approval date [1] 292447 0
15/06/2015
Ethics approval number [1] 292447 0
HREC/15/QRBW/126

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 883 883 0 0
/AnzctrAttachments/368069-BMJ Open-2016-Gillespie- (1).pdf

Contacts
Principal investigator
Name 55334 0
A/Prof Brigid M Gillespie
Address 55334 0
NHMRC Centre for Research Excellence in Nursing (NCREN) Centre for Health Practice Innovation (HPI) Menzies Health Institute Qld (MHIQ) Academic 1, G01 Bldg_Rm 2.04, GRIFFITH UNIVERSITY l Gold Coast Campus QLD 4222
Country 55334 0
Australia
Phone 55334 0
+61 7 5552 9718
Fax 55334 0
Email 55334 0
[email protected]
Contact person for public queries
Name 55335 0
Brigid M Gillespie
Address 55335 0
NHMRC Centre for Research Excellence in Nursing (NCREN) Centre for Health Practice Innovation (HPI) Menzies Health Institute Qld (MHIQ) Academic 1, G01 Bldg_Rm 2.04, GRIFFITH UNIVERSITY l Gold Coast Campus QLD 4222
Country 55335 0
Australia
Phone 55335 0
+61 7 5552 9718
Fax 55335 0
Email 55335 0
[email protected]
Contact person for scientific queries
Name 55336 0
Brigid M Gillespie
Address 55336 0
NHMRC Centre for Research Excellence in Nursing (NCREN) Centre for Health Practice Innovation (HPI) Menzies Health Institute Qld (MHIQ) Academic 1, G01 Bldg_Rm 2.04, GRIFFITH UNIVERSITY l Gold Coast Campus QLD 4222
Country 55336 0
Australia
Phone 55336 0
+61 7 5552 9718
Fax 55336 0
Email 55336 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
individual participant data will not be shared as firstly, this was not discussed in the ethics application, Secondly, a secondary analysis is planned and lastly, the sharing of data can also lead to misinterpretation of the data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10114Study protocol    368069-(Uploaded-29-01-2020-14-32-34)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAdding negative pressure to improve healING (the DRESSING trial): A RCT protocol.2016https://dx.doi.org/10.1136/bmjopen-2015-010287
EmbaseProphylactic negative pressure wound therapy for obese women after cesarean delivery: A systematic review and meta-analysis.2017https://dx.doi.org/10.1097/AOG.0000000000002259
EmbaseProphylactic negative pressure wound therapy at caesarean: are we there yet?.2019https://dx.doi.org/10.1111/1471-0528.15572
EmbaseClosed incision negative pressure wound therapy versus standard dressings in obese women undergoing caesarean section: Multicentre parallel group randomised controlled trial.2021https://dx.doi.org/10.1136/bmj.n893
N.B. These documents automatically identified may not have been verified by the study sponsor.