ANZCTR - Registration

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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]

Nil known.

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Surgical site healing.

Condition category

Condition code

Surgery

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]

Treatment: Surgery

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Incidence of infection (cellulitis and/or abscess) as indicated by the need for an antibiotic prescription.

Timepoint [1]

Participant questionnaire at 6 weeks post-intervention.

Primary outcome [2]

Rates of wound dehiscence as guided by patient-provided photo follow-up.

Timepoint [2]

Day 5 and 6 weeks post-intervention.

Primary outcome [3]

Rates of patient-reported discomfort, as indicated by the patient follow-up questionnaire.

Timepoint [3]

6 weeks post-intervention.

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Not applicable.

Address [1]

Not applicable.

Country [1]

Primary sponsor type

Individual

Name

Dr Kiran Atmuri

Address

Frankston Hospital
2 Hastings Road
Frankston, VIC 3199.

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Peninsula Health Human Research Ethics Committee

Ethics committee address [1]

The Convenor
C/- Manager Office for Research
Peninsula Health 
PO BOX 52
Frankston, VIC 3199.

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

31/01/2023

Ethics approval number [1]

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

Dr Kiran Atmuri

Address

Frankston Hospital
2 Hastings Road
Frankston, VIC 3199.

Country

Australia

Phone

+61397848564

Fax

katmuri@phcn.vic.gov.au

Contact person for public queries

Name

Deepika Jangala

Address

Frankston Hospital
2 Hastings Road
Frankston, VIC 3199.

Country

Australia

Phone

+61397847777

Fax

djangala@phcn.vic.gov.au

Contact person for scientific queries

Name

Deepika Jangala

Address

Frankston Hospital
2 Hastings Road
Frankston, VIC 3199.

Country

Australia

Phone

+61397847777

Fax

djangala@phcn.vic.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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