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Trial registered on ANZCTR


Registration number
ACTRN12623000212651
Ethics application status
Approved
Date submitted
1/02/2023
Date registered
28/02/2023
Date last updated
28/02/2023
Date data sharing statement initially provided
28/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A novel knot-free proximal skin closure technique for transverse caesarean section skin incisions
Scientific title
Patient outcomes following a novel knot-free proximal skin closure technique for transverse caesarean section skin incisions.
Secondary ID [1] 308870 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical site healing. 328863 0
Condition category
Condition code
Surgery 325860 325860 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be given patient information and a consent form.

The intervention is the surgical skin closure technique. The participant’s caesarean section skin layer will be closed with the standard suture material used for caesarean sections which is 3/0 Monocryl suture. It will be closed in the standard manner in a subcuticular technique. The final closure of the skin will be modified to the novel knot-free technique which is being studied. The proposed skin closure technique does not add any extra time to the standard skin closure technique which is less than 5 minutes.The proposed technique is described step-wise below:
- Step 1: Perform routine subcuticular suture from distal end (assistant end) to proximal end (surgeon end). Bring needle out precisely at apex of wound.
- Step 2: Pull suture through to re-approximate wound without excessive tension and puckering in the skin.
- Step 3: Loop and bring the needle back under where the suture exited the wound at the apex.
- Step 4: Bring the needle out of the skin approximately 5-10mm below the wound
- Step 5: Re-enter the skin 2mm medial to the previous exit point, and bring the needle out of the skin 5-10mm above and medial to the apex of the wound
- Step 6: Cut suture flush to skin
- Step 7: Apply adhesive Steri-strips the proximal apex of the wound

The intervention will be performed by Obstetricians (>6 years experience), or Obstetric Registrars (variable experience) under the supervision of Obstetricians.

Adherence will be monitored by having a research team member present at the time of intervention.

This intervention will be performed in a secondary-level teaching hospital.

Participants will be followed up over a period of 6 weeks from the day of delivery. Participants will undergo daily wound review whilst in the hospital, as is standard protocol at the study site. In addition to this standard of care, participants will be asked to provide two pieces of follow-up data to track safe wound healing: (1) A short questionnaire screening for safety concerns with regard to appropriate wound healing; and (2) A photo of the wound to track wound healing progress. The questionnaire has been designed specifically for this study.
Participants will be required to send this questionnaire and photo via email to the researcher’s secure email account on Day 5 and 6 weeks postoperatively.
Intervention code [1] 325318 0
Treatment: Surgery
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333689 0
Incidence of infection (cellulitis and/or abscess) as indicated by the need for an antibiotic prescription.
Timepoint [1] 333689 0
Participant questionnaire at 6 weeks post-intervention.
Primary outcome [2] 333690 0
Rates of wound dehiscence as guided by patient-provided photo follow-up.
Timepoint [2] 333690 0
Day 5 and 6 weeks post-intervention.
Primary outcome [3] 333691 0
Rates of patient-reported discomfort, as indicated by the patient follow-up questionnaire.
Timepoint [3] 333691 0
6 weeks post-intervention.
Secondary outcome [1] 417948 0
Assess the feasibility of the study design by evaluating the ease of clinician training and implementation of suture technique via surgeon questionnaire.

The questionnaire has been designed specifically for this study.
Timepoint [1] 417948 0
At the completion of intervention.

Eligibility
Key inclusion criteria
1. Booked for elective caesarean section.
2. Aged >= 18 years.
3. BMI <40 at booking.
4. English-speaking women.
5. First caesarean section.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women undergoing emergency caesarean section.
2. Women with keloid scarring.
3. Women who have medical co-morbidities that may impair wound healing (smoking, Type 2 diabetes, existing autoimmune skin conditions such as eczema or psoriasis).
4. Women who are unable to give informed consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 313090 0
Self funded/Unfunded
Name [1] 313090 0
Not applicable.
Country [1] 313090 0
Primary sponsor type
Individual
Name
Dr Kiran Atmuri
Address
Frankston Hospital
2 Hastings Road
Frankston, VIC 3199.
Country
Australia
Secondary sponsor category [1] 314784 0
None
Name [1] 314784 0
Address [1] 314784 0
Country [1] 314784 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312335 0
Peninsula Health Human Research Ethics Committee
Ethics committee address [1] 312335 0
The Convenor
C/- Manager Office for Research
Peninsula Health
PO BOX 52
Frankston, VIC 3199.
Ethics committee country [1] 312335 0
Australia
Date submitted for ethics approval [1] 312335 0
Approval date [1] 312335 0
31/01/2023
Ethics approval number [1] 312335 0

Summary
Brief summary
This pilot study will investigate the use of a new knot-free skin closure technique for caesarean section skin wounds. By using this new method to close the skin wound, the researchers aim to reduce the risk of post-operative wound infections and improve patient comfort, whilst also providing surgeons with an easy and reproducible skin closure technique. Currently, a surgical knot named an ‘Aberdeen knot’ is placed beneath the skin at the end of a running stitch during the skin closure at caesarean section. Unfortunately, patients have reported discomfort from the bulky nature of this knot and the bulky knot also increases the risk of wound infection and wound breakdown.

Participants will have the proposed skin closure technique performed at the time of their caesarean section and will then be monitored post-operatively by the midwifery and medical staff at Frankston Hospital. Participants will also be required to submit serial photographs and short questionnaires as means of follow-up. This will allow for appropriate monitoring for any wound complications, such as wound infection or wound breakdown.

The researchers hope to prove that this knot-free skin closure technique is safe for use in closing the skin wound during caesarean section. Should this small initial study prove to be safe and of good design, a larger randomised trial will be commenced.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124298 0
Dr Kiran Atmuri
Address 124298 0
Frankston Hospital
2 Hastings Road
Frankston, VIC 3199.
Country 124298 0
Australia
Phone 124298 0
+61397848564
Fax 124298 0
Email 124298 0
katmuri@phcn.vic.gov.au
Contact person for public queries
Name 124299 0
Dr Deepika Jangala
Address 124299 0
Frankston Hospital
2 Hastings Road
Frankston, VIC 3199.
Country 124299 0
Australia
Phone 124299 0
+61397847777
Fax 124299 0
Email 124299 0
djangala@phcn.vic.gov.au
Contact person for scientific queries
Name 124300 0
Dr Deepika Jangala
Address 124300 0
Frankston Hospital
2 Hastings Road
Frankston, VIC 3199.
Country 124300 0
Australia
Phone 124300 0
+61397847777
Fax 124300 0
Email 124300 0
djangala@phcn.vic.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.