Scalpel Versus Diathermy for Transverse Abdominal Incision in First Elective Caesarean Section

Not Applicable

Not yet recruiting

• Conditions: Cesarean Section; Wound Heal; Postoperative Pain; Intraoperative Blood Loss
• Interventions: Procedure: Skin incision with a diathermy.; Procedure: Skin incision with scalpel.

• Registration Number: NCT05905861
• Lead Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Brief Summary

The objective of this study will be to compare two methods of skin incisions during the first caesarean section (CS), that is scalpel and diathermy, assessing differences in blood loss during incision, incisional time, total surgery time, post-operative pain, wound healing, complications, and cosmetic outcomes.

Detailed Description

The scalpel has been historically used as the primary cutting tool during caesarean section (CS). However, advancements in surgical devices have introduced alternatives, such as the option to make a diathermic cut using electrosurgical units.

General surgeons have extensively demonstrated the advantages of diathermy over the scalpel for abdominal wall incisions, including faster opening time, reduced incisional blood loss, decreased post-operative pain, and a comparable wound complication rate.

In obstetrics, there is a scarcity of evidence in this regard, and no consensus or guidelines have been established regarding the optimal method for making a transverse abdominal incision during the first elective CS. Currently, the choice between using a scalpel or diathermy remains at discretion of the obstetric surgeon. The objective of this study will be to compare both methods of skin incisions during the first CS, assessing differences in blood loss during incision, incisional time, total surgery time, post-operative pain, wound healing, complications, and cosmetic outcomes.

Study Timeline

• Study First Submitted: 2023-06-07
• Study First Submitted QC: 2023-06-07
• Study First Posted: 2023-06-15
• Status Verified: 2023-07
• Study Start: 2023-07
• Last Update Submitted: 2023-07-07
• Last Update Posted: 2023-07-10
• Primary Completion: 2024-06
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

1. Women without a history of previous cesarean section or other abdominal surgery
2. Age greater then 18 years (only adult patients)
3. Body Mass Index (BMI) between 18.5 and 29.9 kg/m2
4. Gestational age greater then 37 weeks (at term pregnancies)
5. No contraindications to spinal anesthesia
6. Indication to elective CS: extra-obstetrical reasons, failure of medical induction of labor, breech fetal presentation
7. Informed consent

Exclusion Criteria

1. Women refusing to participate in the study
2. Women undergoing urgency or emergency cesarean deliveries
3. Women with a history of previous cesarean section or abdominal surgery
4. Women with multifetal pregnancies
5. Necessity of general anesthesia
6. Use of anticoagulants
7. Patients needing a median longitudinal abdominal section
8. Patients with pacemakers
9. Allergy to cephalosporins
10. Any medical disorder that can affect wound healing as diabetes, hypertension, hepatic or renal diseases, chronic anemia, chronic skin conditions, congenital or acquired bleeding diathesis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group_B: skin incision with diathermy.	Skin incision with a diathermy.	In the diathermy group, the incision will be made using a small flat blade pen electrode without applying pressure. The electrode will be set to cutting mode, delivering a sinusoidal current of maximum 120 watts.
Group_A: skin incision with scalpel.	Skin incision with scalpel.	In the scalpel group, the skin incision will be made using the traditional method, with a scalpel (No. 22).

Primary Outcome Measures

Name	Time	Method
Incision blood loss	During surgery	This will be calculated by weighing the gauze pre and postoperatively (1mg = 1ml) after complete hemostasis will be achieved.

Secondary Outcome Measures

Name	Time	Method
Total surgery time	During surgery	Total surgery time will be the time between the start of the skin incision and the completion of the skin suture.
Incision time	During surgery	We will compare incisional time by using a digital clock. The incisional time will be established as follows: when skin incision will be made, the surgeon will verbally announce "start ". Once the parietal peritoneum will be opened, the surgeon will announce "stop". The incision time will be calculated as the difference between "start" and "stop" times.
Wound complications	During the first month after surgery	Will include edema, seroma, hematoma, dehiscence, and infection. The wound will be evaluated 24h and 72h after surgery, before patients discharge. Then, outpatient wound evaluation will be made 7 and 30 days after surgery.
Post-operative pain assessed by VAS	During the first three days after surgery	Post-operative pain will be evaluated for each participant at 1, 4, 8, 16, 24, 48, 72 hours postoperatively, by using the Visual Analog Scale (VAS). The VAS consists of a 10 cm long horizontal line with its extremes marked as 'no pain' (0) and 'worst pain imaginable' (10).
Cosmetic wound evaluation assessed by POSAS	One month after surgery	The cosmetic aspect of the wound will be evaluated outpatient 30 days after surgery by using the Patient and Observer Scar Assessment Scale (POSAS), that is a questionnaire that was developed to assess scar quality. It consists of two separate six-item scales (Observer Scale and Patient Scale), both of which are scored on a 10-point rating scale (1 = best result; 10 = worst result).

Trial Locations

Locations (1)

Azienda Ospedaliero-Universitaria "Consorziale Policlinico"; 🇮🇹 Bari, Italy