None listed
Conditions
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.
Interventions
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
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.
Sponsors
Dr Kiran Atmuri
Study design
Allocation
Non-randomised trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed