Scalpel Versus Diathermy in Transverse Abdominal Skin Incision During Cesarean Section

Skin Wound Clinical Trial

Official title:

A Comparative Study Between the Use of Scalpel Versus Diathermy in Opening the Transverse Abdominal Skin Incision During Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06352853
• Other study ID #: Diathermy and skin incision cs
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: October 1, 2022

Study information

• Verified date: April 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 group;Diathermy group and scalpel group respectively .

• Randomization achieved using computer generated randomization sequences. Allocation was in 1:1 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 2.0 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 (e.g.: no pain) to "10" representing the other pain extreme (e.g.: "pain as bad as you can imagine" or "worst pain imaginable") this will be recorded at 2,4, 6,8, 10,12, 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Elective cesarean section.

• Women with body mass index less than 30.

• Transverse skin incision.

Exclusion Criteria:

• Women with medical disorder that can affect wound healing as diabetes, hypertension, chronic anemia and with chronic skin conditions as psoriasis and eczema.

• Women with Autoimmune disorders.

• Cardiac patients on pacemakers and patients on anticoagulants.

Related Conditions & MeSH terms

• Hyperthermia
• Skin Wound

Intervention

Other:
• Skin incision in Cesarean Section by Diathermy
Skin incision by diathermy
• Skin incision in Cesarean Section by Scalpel
Skin incision by scalpel

Locations

Country	Name	City	State
Egypt	Shaimaa El Shemy	Giza	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin incision time in scalpel versus diathermy group	The incision time was estimated 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".	5 months
Primary	Estimation of incision blood loss in both groups	incision blood loss volume was measured by weighing the swabs pre and postoperatively (1mg = 1ml).	5 months
Secondary	Postoperative pain in both groups	Evaluation of post operative pain for 24 hours by visual analogue scale	5 months
Secondary	Postoperative wound healing in both groups	Postoperative wound complications like seroma, hematoma, ecchymosis, dehiscence (separation of the subcutaneous tissues with skin) 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.	5 months