Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001408774p
Ethics application status
Submitted, not yet approved
Date submitted
28/09/2022
Date registered
3/11/2022
Date last updated
3/11/2022
Date data sharing statement initially provided
3/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Antimicrobial Sealants at Lower Uterine Caesarean section on rates of surgical site infection: A Pilot Trial
Scientific title
Antimicrobial Sealants at Lower Uterine Caesarean section on rates of surgical site infection: A Pilot Trial
Secondary ID [1] 307452 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
The SEAL trial
"antimicrobial SElants At Lower uterine caesarean section on rates of surgical site infection"
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical Site Infection 326830 0
Caesarean section 326831 0
Condition category
Condition code
Reproductive Health and Childbirth 324042 324042 0 0
Childbirth and postnatal care
Surgery 324896 324896 0 0
Other surgery
Infection 324897 324897 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Application of Antimicrobial sealant (Floraseal (Registered) Adhezion Biomedical) to surgical site following skin preparation with 2% chlorhexidine gluconate/70% Isopropyl alcohol prior to draping and skin incision for Caesarean section. The antimicrobial sealant will be applied once only in the operating theatre prior to draping and skin incision. The sealant will cover the intended surgical site and an additional 4-5 centimetres surrounding this. The sealant will be left to dry until the skin in no longer tacky, as per manufacturers instructions. A case report form will be completed by surgeons following the operation detailing notable variables including BMI, measured blood loss and operative time.

Participants will be provided information resources produced by the product developer regarding the nature of the antimicrobial sealant prior to consenting to participate in the study and throughout the study process.

The Antimicrobial sealant will be applied by the surgeon across the intended surgical field using the device applicator. The surgeon will be trained in the correct application by viewing instructional videos created by the produce developer as seen here https://vimeo.com/417865438
Intervention code [1] 323904 0
Treatment: Devices
Intervention code [2] 324577 0
Prevention
Comparator / control treatment
Standard peri-operative skin preparation with 2% chlorhexidine gluconate/70% Isopropyl alcohol. A case report form will be completed by surgeons following the operation detailing notable variables including BMI, measured blood loss and operative time
Control group
Active

Outcomes
Primary outcome [1] 331833 0
Rate of Surgical Site infection as assessed by the Centre for Disease Control and Prevention (CDC) definition of a surgical site infection. This will be assess via medical teleconference software using Coviu technology and where there is doubt regarding whether an infection is present, photographic evidence of the wound which is reviewed by a second reviewer
Timepoint [1] 331833 0
Within 30 days post-operatively

Inpatient
- Patients will be reviewed on day 1 following their surgery by a medical officer and then daily by the midwifery staff for the duration of their hospital admission, as is standard practice.

Post Discharge
- Patients will re contacted via medical teleconference twice following discharge, once on day 7-10 and again on day 28-30. Each participant will only be contacted once during each the two follow up periods (day 7-10 and day 28-30)
- if not successful to reach the participant, a text message will be sent notifying the purpose of the call. One additional video call will be made on the same day within the clinic session. Should the patient fail to answer this call a phone call on the same day will be made to allow for technical issues with the video call.
Secondary outcome [1] 411339 0
Rate of Antibiotic Prescription recorded from either
- Prescription as an inpatient following surgery OR during readmission with SSI using review of medical records and patient described prescription
- Patient described administration of antibiotics as an outpatient following discharge
Timepoint [1] 411339 0
Within 30 days post-operatively

Inpatient
- Patients will be reviewed on day 1 following their surgery by a medical officer and then daily by the midwifery staff for the duration of their hospital admission, as is standard practice.

Post Discharge
- Patients will re contacted via medical teleconference twice following discharge, once on day 7-10 and again on day 28-30. Each participant will only be contacted once during each the two follow up periods (day 7-10 and day 28-30)
- if not successful to reach the participant, a text message will be sent notifying the purpose of the call. One additional video call will be made on the same day within the clinic session. Should the patient fail to answer this call a phone call on the same day will be made to allow for technical issues with the video call.
Secondary outcome [2] 414188 0
Rate of readmission with Surgical Site Infection recorded from either
- Accessing hospital records
- Patient described readmission for surgical site infection
Timepoint [2] 414188 0
Within 30 days post-operatively
Secondary outcome [3] 414191 0
Rate of Skin irritation as describe by patients as Yes or No
Timepoint [3] 414191 0
Within 30 days post-operatively

Inpatient
- Patients will be reviewed on day 1 following their surgery by a medical officer and then daily by the midwifery staff for the duration of their hospital admission, as is standard practice.

Post Discharge
- Patients will re contacted via medical teleconference twice following discharge, once on day 7-10 and again on day 28-30. Each participant will only be contacted once during each the two follow up periods (day 7-10 and day 28-30)
- if not successful to reach the participant, a text message will be sent notifying the purpose of the call. One additional video call will be made on the same day within the clinic session. Should the patient fail to answer this call a phone call on the same day will be made to allow for technical issues with the video call.
Secondary outcome [4] 414208 0
Patient reported quality of recovery following Caesarean section, assessed using the Obstetric Quality of Recovery -11 Tool (ObsQoR-11) which includes a visual scoring scale.
Timepoint [4] 414208 0
Within 30 days post-operatively

Post Discharge
- Patients will re contacted via medical teleconference twice following discharge, once on day 7-10 and again on day 28-30. Each participant will only be contacted once during each the two follow up periods (day 7-10 and day 28-30)
- if not successful to reach the participant, a text message will be sent notifying the purpose of the call. One additional video call will be made on the same day within the clinic session. Should the patient fail to answer this call a phone call on the same day will be made to allow for technical issues with the video call.

Eligibility
Key inclusion criteria
• Age between 18-50
• Undergoing elective Caesarean section
• Able to consent to participate
• English Speaking
• >37 completed weeks gestation
Minimum age
18 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to consent
• Midline laparotomy at caesarean section
• History of allergy to antimicrobial sealants/cyanoacrylate
• Evidence of infection at or adjacent to the surgical site
• Undergoing emergency Caesarean Section
• Chorioamnionitis; suspected or confirmed

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)
Allocation will be concealed using opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will conduct block randomisation using a block size of 4. A computer-generated block randomization method using excel/similar software will be used to randomize participants into placebo and treatment groups instead of simple sequence randomisation. This method will ensure a balance in sample size across the two groups. A dedicated biostatistician/data analyst will be nominated to conduct the randomisation to ensure blinding during data collection and data analysis
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
At completion of the study analysis will involve comparing proportion of surgical site infections using chi-squared tests and continuous variable measures using t-tests. If the data does not have a normal distribution then non-parametric tests such as the Mann Whitney U test will be used between the two groups. Descriptive statistics will be used to display the baseline characteristics of the study participants. Finally, we also plan to conduct multiple logistic regression analyses to determine if use of Floraseal is a significant predictor for reduced surgical site infection post C section. We will aim to adjust for other potential factors in the regression model including BMI, immunocompromised pts, hx of diabetes etc.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/04/2023
Actual
Date of last participant enrolment
Anticipated
1/10/2024
Actual
Date of last data collection
Anticipated
1/11/2024
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23231 0
The Royal Women's Hospital - Parkville
Recruitment postcode(s) [1] 38600 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 312318 0
Hospital
Name [1] 312318 0
Royal Women's Hopsital
Country [1] 312318 0
Australia
Primary sponsor type
Individual
Name
Dr Samuel Cresser
Address
Gynae 1 Unit, Royal Women's Hospital, 20 Flemington Road, Parkville, VIC 3052
Country
Australia
Secondary sponsor category [1] 313871 0
None
Name [1] 313871 0
Address [1] 313871 0
Country [1] 313871 0
Other collaborator category [1] 282443 0
Individual
Name [1] 282443 0
Dr W. Catarina Ang
Address [1] 282443 0
Gynae 1 Unit,Royal Women's Hospital, 20 Flemington Road, Parkville, VIC 3052
Country [1] 282443 0
Australia
Other collaborator category [2] 282444 0
Individual
Name [2] 282444 0
Dr Owen Stock
Address [2] 282444 0
Gynae 1 Unit, Royal Women's Hospital, 20 Flemington Road, Parkville, VIC 3052
Country [2] 282444 0
Australia
Other collaborator category [3] 282453 0
Individual
Name [3] 282453 0
Dr Eashan Tambimuttu
Address [3] 282453 0
Gynae 1 Unit, Royal Women's Hospital, 20 Flemington Road, Parkville, VIC 3052
Country [3] 282453 0
Australia
Other collaborator category [4] 282454 0
Individual
Name [4] 282454 0
Dr Tarana Lucky
Address [4] 282454 0
Gynae 1 Unit, Royal Women's Hospital, 20 Flemington Road, Parkville, VIC 3052
Country [4] 282454 0
Australia
Other collaborator category [5] 282455 0
Individual
Name [5] 282455 0
Dr Shamitha Kathurusinghe
Address [5] 282455 0
Gynae 1 Unit, Royal Women's Hospital, 20 Flemington Road, Parkville, VIC 3052
Country [5] 282455 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311172 0
Royal Womens Hospital Human Research Ethics Committee
Ethics committee address [1] 311172 0
20 Flemington Road, Parkville, VIC, 3052
Ethics committee country [1] 311172 0
Australia
Date submitted for ethics approval [1] 311172 0
26/10/2022
Approval date [1] 311172 0
Ethics approval number [1] 311172 0

Summary
Brief summary
The proposed pilot trial will be the first of its kind in the world with an aim to assess the role of using an antimicrobial sealant in reducing the incidence of surgical site infection following elective caesarean section. We believe this study will assist in planning and implementation of methods to minimise post operative complications, maximise recovery after surgery, and increase patient satisfaction.

By participating in the study you will be allocated randomly to either a treatment group or a control group on the day of your operation. Participants allocated in the treatment group will have an antimicrobial sealant and antibacterial skin preparation applied to their abdomen before the caesarean section begins. Participants in the control group will receive only antibacterial skin preparation (routine surgical care) prior to their caesarean section. Although at this point you will have an epidural/spinal anaesthetic, the application of the antimicrobial sealant is not painful.

Following your procedure, we will care for you as we usually would following a caesarean section. We will record any evidence of surgical site infection whilst you are an inpatient. Once you are discharged from hospital, we will continue to check in with you on Day 7-10 and day 28-30 post operatively to assess for the development of infection. We will contact you through a videoconference call so we can both talk to you and review your wound visually. We will also ask you to take a picture of your caesarean wound at these video conference reviews which we will keep to assess for infection. There will be no identifying features on these photos, so you don’t need to worry about being identified from the photo. All photographs will be deleted following the mandatory period in which they are required to be stored. We will also assess your recovery activity using another visual scoring system, which will be provided to you on you discharge from hospital.

We will use the collated information to determine whether using an antimicrobial sealant reduces the likelihood of developing a surgical site infection after a Caesarean section, compared to current standard practice. We will also look at the rate of readmission to hospital with infection following the operation, rate of skin irritation, rate of antibiotic prescription and overall recovery following the Caesarean section between the two groups
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120206 0
Dr Samuel Cresser
Address 120206 0
Gynae 1 Unit, Royal Womens Hopsital, 20 Flemington Road, Parkville, VIC, 3052
Country 120206 0
Australia
Phone 120206 0
+61 03 8345 2000
Fax 120206 0
Email 120206 0
samuel.cresser@thewomens.org.au
Contact person for public queries
Name 120207 0
Dr Samuel Cresser
Address 120207 0
Gynae 1 Unit, Royal Womens Hopsital, 20 Flemington Road, Parkville, VIC, 3052
Country 120207 0
Australia
Phone 120207 0
+61 03 8345 2000
Fax 120207 0
Email 120207 0
samuel.cresser@thewomens.org.au
Contact person for scientific queries
Name 120208 0
Dr Samuel Cresser
Address 120208 0
Gynae 1 Unit, Royal Womens Hopsital, 20 Flemington Road, Parkville, VIC, 3052
Country 120208 0
Australia
Phone 120208 0
+61 03 8345 2000
Fax 120208 0
Email 120208 0
samuel.cresser@thewomens.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
COnsensus decision reached by investigator group


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17207Study protocol  Samuel.cresser@thewomens.org.au
17208Statistical analysis plan  Samuel.cresser@thewomens.org.au
17209Informed consent form  Samuel.cresser@thewomens.org.au
17210Clinical study report  Samuel.cresser@thewomens.org.au
17211Ethical approval  Samuel.cresser@thewomens.org.au



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.