Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000768897
Ethics application status
Approved
Date submitted
4/07/2012
Date registered
19/07/2012
Date last updated
19/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Reducing Surgical Site Infection in Caesarean Section: Is there a role for antibacterial sutures?
Scientific title
Does the use of antibacterial (Triclosan) impregnated sutures at the time of performing caesarean section reduce the incidence of surgical site infection in postpartum women when compared to standard sutures?
Secondary ID [1] 280776 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical site infection after caesarean section. 285870 0
Condition category
Condition code
Reproductive Health and Childbirth 286055 286055 0 0
Childbirth and postnatal care
Infection 286056 286056 0 0
Studies of infection and infectious agents
Surgery 287145 287145 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of Triclosan-coated sutures for closure of rectus muscle sheath and skin at caesarean section. Closure of the rectus sheath and skin usually takes about 10 minutes but does vary from case to case depending on the patient and the operator.
Intervention code [1] 284286 0
Treatment: Surgery
Intervention code [2] 285202 0
Prevention
Comparator / control treatment
Use of standard, non-antibacterial, sutures for closure of the rectus muscle sheath and skin at caesarean section.
Control group
Active

Outcomes
Primary outcome [1] 286535 0
Surgical site infection.
Using the standard follow-up tool to our department - the "Lead Maternit Carer" (LMC) reviews the patient regularily once discharged over the 6 weeks post-partum. Any surgical site infection is reported back at 6 weeks.
The surgical site infection is defines as:
Superficial and Deep Surgical Site Infection: Infection within 30 days of operation.
Superficial - involves skin/sub-cut tissue of incision only and one of; purulent discharge, organisms isolated from aseptically obtained culture, pain or tenderness, localised swelling, redness, heat, superficial incision opened by surgeon unless culture negative, diagnosis of infection by attending physician/surgeon.
Deep - involves deep soft tissue and one of; purulant discharge, spontaneous dehiscence or deliberately opened in the presence of temp >38C or pain/tenderness unless culture negative, abscess found on examination during surgery, radiology or histopathology, diagnosis of deep infection by attending physician/surgeon.
Timepoint [1] 286535 0
Wound infection within 30 days post-caesarean section reported back at 6 weeks post-partum by the LMC.
Secondary outcome [1] 296105 0
Wound/fascial dehiscence.
In event of suspected wound dehiscence the patient will be reviewed at Dunedin Hospital, Queen Mary Maternity Services and fascial dehiscence will be diagnosed by medical staff (independant medical examination).
Timepoint [1] 296105 0
Within 30 days post-caesarean section.

Eligibility
Key inclusion criteria
Elective, semi-elective and emergency caesarean sections in women seen and consented in an Antenatal Clinic or Antenatal Ward setting prior to presentation on the day of surgery. (E.g. including women undergoing emergency caesarean section during attempted vaginal birth after previous caesarean section if seen and consented in antenatal clinic on a prior occasion).
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pre-existing Type 1 or 2 Diabetes (not Gestational diabetes which should resolve post-delivery and remove the increased risk of infection post-operatively).

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)
Information about the study will be passed to women either attending antenatal clinic or present on the antenatal ward and planned/high risk for a Caesarean section. Consent shall be taken if a woman agrees to enter the study and is not in labour.
Envelope method with variable block size – chosen to reduce any perceived complication of randomisation (especially in the case of Emergency Caesareans performed at night) and increase uptake.
Randomised by the circulating midwife, prepared by the scrub midwife and then blinded to the surgeon, woman undergoing caesarean and LMC.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Opaque envelope method with variable block size.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
550
Accrual to date
Final
Recruitment outside Australia
Country [1] 4136 0
New Zealand
State/province [1] 4136 0
Otago

Funding & Sponsors
Funding source category [1] 285549 0
Hospital
Name [1] 285549 0
Dunedin Hospital, Research Project Initiative Award, Southland DHB.
Country [1] 285549 0
New Zealand
Primary sponsor type
Individual
Name
Jana Morgan
Address
Women's Health Department,
Dunedin Hospital,
Great King Street,
Dunedin 9012.
Country
New Zealand
Secondary sponsor category [1] 284384 0
Individual
Name [1] 284384 0
Helen Paterson
Address [1] 284384 0
Women's Health Department,
Dunedin Hospital,
Great King Street,
Dunedin 9012.
Country [1] 284384 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286727 0
Central Regional Ethics Committee
Ethics committee address [1] 286727 0
Ministry of Health,
PO Box 5013,
1 The Terrace,
Wellington 6011.
Ethics committee country [1] 286727 0
New Zealand
Date submitted for ethics approval [1] 286727 0
13/03/2012
Approval date [1] 286727 0
Ethics approval number [1] 286727 0

Summary
Brief summary
This trial is hoping to find out if a new type of antibacterial-coated stitch will help to reduce the risk of infection in the wound after Caesarean Section delivery. At the time of Caesarean Section we will pick, by chance, half of the women in the study to receive the coated stitch in place of the routine non-antibacterial stitch when closing the skin and deeper layers but not the uterus (womb). All other aspects of the care relating to the Caesarean Section will remain unchanged. The follow-up and post-operative care will remain as standard. 30 days after the operation we will collect information from the patient’s midwife/LMC about whether she has had any signs or symptoms that might suggest infection in the wound. Treatment of any infection will not be altered or delayed because of the trial.
We will use this information to find out if the antibacterial stitch reduces the risk of infection for women after Caesarean Section.
We hypothosise that the antibacterial stitch will reduce the occurance of wound infection.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33788 0
Address 33788 0
Country 33788 0
Phone 33788 0
Fax 33788 0
Email 33788 0
Contact person for public queries
Name 17035 0
Jana Morgan
Address 17035 0
Dunedin Hospital,
Great King Street,
Dunedin 9012.
Country 17035 0
New Zealand
Phone 17035 0
+64 02102242419
Fax 17035 0
Email 17035 0
[email protected]
Contact person for scientific queries
Name 7963 0
Jana Morgan
Address 7963 0
Dunedin Hospital,
Great King Street,
Dunedin 9012.
Country 7963 0
New Zealand
Phone 7963 0
+64 21 022 42419
Fax 7963 0
Email 7963 0
[email protected]

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
No additional documents have been identified.