Efficacy of Diathermy on Healing Power of Cesarean Section Scar (EDHPCS)

Ain Shams University

Status: Completed

Conditions: Healing Surgical Wounds

Treatments: Device: diathermy; Device: scalpel

Study type: Interventional

Funder types: Other

Identifiers

NCT03988972

27180413

Details and patient eligibility

About

To compare the effects of electro-surgery on healing power as a primary outcome (from skin to the peritoneum. And volume of blood loss, incision time and postoperative surgical wound pain as secondary outcomes.

Full description

This is a prospective study is carried out at Ain Shams University Maternity Hospital, Obstetrics and Gynecology Department, Faculty of medicine in women undergoing CS through pfannentiel incisions.

All women will receive intravenous antibiotic prophylaxis according to the Ain Shams guideline, 1 g of cefazolin given at the time of incision.

Diathermy incisions will be carried out using monopolar blade pen electrode, set on cutting mode and delivering a 35 continuous current. Electrosurgical cutting will be performed without pressure or mechanical displacement.

'Bleeders' will be controlled by using diathermy, on coagulating mode, and will be applied to a hemostat on the vessels.

Incisions made by the scalpel will be done by the traditional method, with proper hemostasis by application of pressure to skin blood vessels and by ligating the subcutaneous bleeders.

After the operation and during the postoperative period, paracetamol (10mg/mL) 50-mL vial will be administered by i.v. infusion for analgesia on demand according to the patient's need with a 500-mg dose. And the wound will be sutured subcuticle by a prolene 3.0 sutures.

Enrollment: 180 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Primi-section
• BMI (18-29) kg/m^2.
• Age from (18-40).
• Women undergoing CS with Pfannenstiel incision.

Exclusion criteria

• Women with one of the following conditions:

Patients requiring midline incision or on anti-coagulant therapy

• Cardiac patients on pacemakers and patients with chronic diseases expected to affect wound healing, such as diabetes, liver diseases, chronic anemia and renal impairment
• Obese patients BMI (>30) kg/m^2.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups

diathermy group

Experimental group

Description:

Diathermy incisions will be carried out using monopolar blade pen electrode, set on cutting mode and delivering a 35 continuous current. Electrosurgical cutting was performed without pressure or mechanical displacement. 'Bleeders' will be controlled by using diathermy, on coagulating mode, and will be applied to a hemostat on the vessels

Treatment:

Device: diathermy

scalpel group

Active Comparator group

Description:

Incisions made by the scalpel will be done by the traditional method, with proper hemostasis by application of pressure to skin blood vessels and by ligating the subcutaneous bleeders.

Treatment:

Device: scalpel