Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352853
Status:
COMPLETED
Last Update Posted:
2024-04-09
First Post:
2024-04-02
Brief Title:
Scalpel Versus Diathermy in Transverse Abdominal Skin Incision During Cesarean Section
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
A Comparative Study Between the Use of Scalpel Versus Diathermy in Opening the Transverse Abdominal Skin Incision During Cesarean Section
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to compare between using of diathermy versus scalpel in making skin incision during cesarean section to judge the variations in incisional time incisional blood loss postoperative pain wound healing and wound complications
Detailed Description:
Surgical scalpels are traditionally used for skin incisions during a Caesarean delivery the great evolutions in electrosurgical devices bring an alternative method for skin incision by the usage of cutting diathermy
The current comparative study was conducted in Kasr Al-Ainy hospital obstetric theaters between January 2022 and June 2022 Consents were obtained from all participants 120 participants were included in this study divided into 2 groups 60 in each groupDiathermy group and scalpel group respectively
Randomization achieved using computer generated randomization sequences Allocation was in 11 ratio
In both groups
1 Pre-operative patients received cefoperazone 1gm intravenous In case of penicillin allergy they received clindamycin intravenous
2 A Pfannenstiel skin incision was made taken down through the subcutaneous tissue rectus sheath and dissected from rectus muscle until peritoneum was visualized
In scalpel group an incision made by traditional method with proper homeostasis by application of pressure to skin blood vessels and by ligating the subcutaneous bleeding as well as using of diathermy on coagulation mode Then the investigators used the scalpel to reach peritoneum
In diathermy group incision made using a small flat blade pen electrode set on cutting mode and delivering a 120-wat maximum sinusoidal current electrosurgical cutting performed without pressure or mechanical displacement Then the investigators used the scalpel to reach peritoneum
The study compared incisional time by using digital clock time established as follows when skin incision made the surgeon called out start the clock After opening the rectus sheath the surgeon called out stop the clock Incision time is the difference between start and stop
Also incision blood loss was calculated by weighing the swabs pre and postoperatively 1mg 1ml In incisional site no suction was used
Also hemodynamic changes were compared between both groups that include blood pressure systolic blood pressure diastolic blood pressure and mean arterial blood pressure pulse oxygen saturation and electrocardiogram ECG changes
3 Intra-operative patient received Diclofenac sodium 50-100 mg intramuscular and postoperatively they received paracetamol vial 6 hours in both groups
Closure of the skin in all cesarean sections was done by proline 20 for assessment of wound healing and complications
Postoperatively the postoperative pain was compared for 24 hours by visual analogue scale VAS score It is 11 points numeric scale ranges from 0 representing one pain extreme eg no pain to 10 representing the other pain extreme eg pain as bad as you can imagine or worst pain imaginable this will be recorded at 24 68 1012 24 hours postoperatively
Lastly wound healing was compared in both groups and complications like seroma hematoma ecchymosis dehiscence and infection The presence or absence of infection was assessed by Southampton grading system as following
G0 normal wound healing G1 normal healing with mild bruising or erythema G2 erythema plus other signs of inflammation G3 clear or serosanguinous discharge and G4 purulent discharge and in this case wound culture was performed
The current comparative study was conducted in Kasr Al-Ainy hospital obstetric theaters between January 2022 and June 2022 Consents were obtained from all participants 120 participants were included in this study divided into 2 groups 60 in each groupDiathermy group and scalpel group respectively
Randomization achieved using computer generated randomization sequences Allocation was in 11 ratio
In both groups
1 Pre-operative patients received cefoperazone 1gm intravenous In case of penicillin allergy they received clindamycin intravenous
2 A Pfannenstiel skin incision was made taken down through the subcutaneous tissue rectus sheath and dissected from rectus muscle until peritoneum was visualized
In scalpel group an incision made by traditional method with proper homeostasis by application of pressure to skin blood vessels and by ligating the subcutaneous bleeding as well as using of diathermy on coagulation mode Then the investigators used the scalpel to reach peritoneum
In diathermy group incision made using a small flat blade pen electrode set on cutting mode and delivering a 120-wat maximum sinusoidal current electrosurgical cutting performed without pressure or mechanical displacement Then the investigators used the scalpel to reach peritoneum
The study compared incisional time by using digital clock time established as follows when skin incision made the surgeon called out start the clock After opening the rectus sheath the surgeon called out stop the clock Incision time is the difference between start and stop
Also incision blood loss was calculated by weighing the swabs pre and postoperatively 1mg 1ml In incisional site no suction was used
Also hemodynamic changes were compared between both groups that include blood pressure systolic blood pressure diastolic blood pressure and mean arterial blood pressure pulse oxygen saturation and electrocardiogram ECG changes
3 Intra-operative patient received Diclofenac sodium 50-100 mg intramuscular and postoperatively they received paracetamol vial 6 hours in both groups
Closure of the skin in all cesarean sections was done by proline 20 for assessment of wound healing and complications
Postoperatively the postoperative pain was compared for 24 hours by visual analogue scale VAS score It is 11 points numeric scale ranges from 0 representing one pain extreme eg no pain to 10 representing the other pain extreme eg pain as bad as you can imagine or worst pain imaginable this will be recorded at 24 68 1012 24 hours postoperatively
Lastly wound healing was compared in both groups and complications like seroma hematoma ecchymosis dehiscence and infection The presence or absence of infection was assessed by Southampton grading system as following
G0 normal wound healing G1 normal healing with mild bruising or erythema G2 erythema plus other signs of inflammation G3 clear or serosanguinous discharge and G4 purulent discharge and in this case wound culture was performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None