Efficacy of Diathermy on Healing Power of Cesarean Section Scar

Not Applicable

Completed

• Conditions: Healing Surgical Wounds
• Interventions: Device: diathermy; Device: scalpel

• Registration Number: NCT03988972
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2019-02-06
• Study First Submitted: 2019-06-11
• Study First Submitted QC: 2019-06-15
• Study First Posted: 2019-06-18
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-19
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
diathermy group	diathermy	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
scalpel group	scalpel	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.

Primary Outcome Measures

Name	Time	Method
Cosmosis	15 days after CS	The primary objective is to compare healing power between two methods then will be followed at 3, 7, 11, and 15 days post-operative using: Visual Analogue Scale The original VAS consisted of a 100-mm line with "worst scar" at the right end of the line and "best scar" at the left end of the line. In this study, VAS ranged from 0 to 10cm. Using the line as a continuous entity, the patient mark on the line where they thought the scar fit.
Healing power	15 days after cs	The wound score addresses 6 clinical variables: absence of stepoff, contour ir- regularities, wound margin separation \>2 mm, edge inversion, excessive distortion, and overall cosmetic appearance. Each of these categories is graded on a O-or-l-point scale. A total cosmetic score is derived by the addition of the scores of the 6 categorical variables. A score of 6 is considered optimal, while a score of ≤5 suboptimal.

Secondary Outcome Measures

Name	Time	Method
postoperative surgical wound pain: VAS scale	24 hours	postoperative surgical wound pain using visual analogue scale (VAS) after 1, 4,6,12 and 24 hours postoperatively. The visual analogue pain scale is a uni-dimensional measure of pain intensity, which has been used in adults. The visual analogue pain scale is an easy assessment tool consisting of a 10 cm line with 0 on one end, representing no pain, and 10 on the other end, representing the worst pain felt.

Trial Locations

Locations (1)

Ain shams maternity teaching hospital; 🇪🇬 Cairo, Abbasia, Egypt