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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05905861
Other study ID # 0049112
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 2023
Est. completion date December 2024

Study information

Verified date July 2023
Source Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Contact Amerigo Vitagliano, MD, PhD
Phone 0805593321
Email amerigo.vitagliano@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 84
Est. completion date December 2024
Est. primary completion date June 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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


Intervention

Procedure:
Skin incision with scalpel.
A Pfannenstiel skin incision will be performed using a scalpel, extending through the subcutaneous tissue and rectus sheath. After separation of rectus muscles, peritoneum will be visualized and opened. Optimal hemostasis will be achieved by applying pressure to skin blood vessels and ligating any subcutaneous bleeding. Group A: skin incision with a scalpel.
Skin incision with a diathermy.
A Pfannenstiel skin incision will be made using a scalpel. Subsequently, a diathermy pen electrode will be employed for the dissection of deeper tissues. Optimal hemostasis will be achieved by using the same blade pen electrode, set to coagulation mode. Group B: skin incision with diathermy.

Locations

Country Name City State
Italy Azienda Ospedaliero-Universitaria "Consorziale Policlinico" Bari

Sponsors (1)

Lead Sponsor Collaborator
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incision blood loss This will be calculated by weighing the gauze pre and postoperatively (1mg = 1ml) after complete hemostasis will be achieved. During surgery
Secondary Incision time 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. During surgery
Secondary Total surgery time Total surgery time will be the time between the start of the skin incision and the completion of the skin suture. During surgery
Secondary Post-operative pain assessed by VAS 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). During the first three days after surgery
Secondary Wound complications 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. During the first month after surgery
Secondary Cosmetic wound evaluation assessed by POSAS 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). One month after surgery
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