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

Primary Purpose

Cesarean Section, Intraoperative Blood Loss, Postoperative Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Skin incision with scalpel.
Skin incision with a diathermy.
Sponsored by
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cesarean Section

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Women without a history of previous cesarean section or other abdominal surgery Age greater then 18 years (only adult patients) Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 Gestational age greater then 37 weeks (at term pregnancies) No contraindications to spinal anesthesia Indication to elective CS: extra-obstetrical reasons, failure of medical induction of labor, breech fetal presentation Informed consent Exclusion Criteria: Women refusing to participate in the study Women undergoing urgency or emergency cesarean deliveries Women with a history of previous cesarean section or abdominal surgery Women with multifetal pregnancies Necessity of general anesthesia Use of anticoagulants Patients needing a median longitudinal abdominal section Patients with pacemakers Allergy to cephalosporins 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.

Sites / Locations

  • Azienda Ospedaliero-Universitaria "Consorziale Policlinico"

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Group_A: skin incision with scalpel.

Group_B: skin incision with diathermy.

Arm Description

In the scalpel group, the skin incision will be made using the traditional method, with a scalpel (No. 22).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Total surgery time
Total surgery time will be the time between the start of the skin incision and the completion of the skin suture.
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).
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.
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).

Full Information

First Posted
June 7, 2023
Last Updated
July 7, 2023
Sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
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1. Study Identification

Unique Protocol Identification Number
NCT05905861
Brief Title
Scalpel Versus Diathermy for Transverse Abdominal Incision in First Elective Caesarean Section
Official Title
Scalpel Versus Diathermy for Transverse Abdominal Incision in Women Undergoing First Elective Caesarean Section: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section, Intraoperative Blood Loss, Postoperative Pain, Wound Heal

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group_A: skin incision with scalpel.
Arm Type
Placebo Comparator
Arm Description
In the scalpel group, the skin incision will be made using the traditional method, with a scalpel (No. 22).
Arm Title
Group_B: skin incision with diathermy.
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Skin incision with scalpel.
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Skin incision with a diathermy.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incision blood loss
Description
This will be calculated by weighing the gauze pre and postoperatively (1mg = 1ml) after complete hemostasis will be achieved.
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
Incision time
Description
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.
Time Frame
During surgery
Title
Total surgery time
Description
Total surgery time will be the time between the start of the skin incision and the completion of the skin suture.
Time Frame
During surgery
Title
Post-operative pain assessed by VAS
Description
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).
Time Frame
During the first three days after surgery
Title
Wound complications
Description
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.
Time Frame
During the first month after surgery
Title
Cosmetic wound evaluation assessed by POSAS
Description
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).
Time Frame
One month after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women without a history of previous cesarean section or other abdominal surgery Age greater then 18 years (only adult patients) Body Mass Index (BMI) between 18.5 and 29.9 kg/m2 Gestational age greater then 37 weeks (at term pregnancies) No contraindications to spinal anesthesia Indication to elective CS: extra-obstetrical reasons, failure of medical induction of labor, breech fetal presentation Informed consent Exclusion Criteria: Women refusing to participate in the study Women undergoing urgency or emergency cesarean deliveries Women with a history of previous cesarean section or abdominal surgery Women with multifetal pregnancies Necessity of general anesthesia Use of anticoagulants Patients needing a median longitudinal abdominal section Patients with pacemakers Allergy to cephalosporins 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amerigo Vitagliano, MD, PhD
Phone
0805593321
Email
amerigo.vitagliano@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amerigo Vitagliano
Phone
0805593321
Email
amerigo.vitagliano@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amerigo Vitagliano, MD, PhD
Organizational Affiliation
"Aldo Moro" University of Bari
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliero-Universitaria "Consorziale Policlinico"
City
Bari
ZIP/Postal Code
70124
Country
Italy

12. IPD Sharing Statement

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

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