An interventional study of Skin incision with scalpel. and Skin incision with a diathermy. in Cesarean Section, Intraoperative Blood Loss and Postoperative Pain, sponsored by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari. Status unknown at 1 site in Italy. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-10.
Sponsored by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari · Not applicable, Interventional, and Supportive care
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.
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.
5,229 studies on the registry are indexed under Pain, Postoperative; 1,155 are open to participants now.
This study's planned enrollment of 84 is above the median of 75 across 4,460 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari is the lead sponsor of 47 studies on the registry; 11 are open to participants now.
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In the scalpel group, the skin incision will be made using the traditional method, with a scalpel (No. 22).
Procedure: Skin incision with scalpel.
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.
Procedure: Skin incision with a diathermy.
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.
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.
Incision blood loss
This will be calculated by weighing the gauze pre and postoperatively (1mg = 1ml) after complete hemostasis will be achieved.
Time frame: During surgery
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.
Time frame: During surgery
Total surgery time
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
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).
Time frame: During the first three days after surgery
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.
Time frame: During the first month 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).
Time frame: One month after surgery
Start is estimated for Jul 2023; primary completion for Jun 2024, 11 months later.
Of 1,890 non-industry interventional studies with no phase under Pain, Postoperative, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 11 months is close to that.
Counting every sponsor, half of 1,903 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari