Efficacy of Diathermy on Healing Power of Cesarean Section Scar

Healing Surgical Wounds Clinical Trial

— EDHPCS  

Official title:

Efficacy of Diathermy on Healing Power of Cesarean Section Scar:A Randomized Control Trail

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03988972
• Other study ID #: 27180413
• Status: Completed
• Phase: N/A
• Start date: February 6, 2019
• Est. completion date: August 1, 2019

Study information

• Verified date: January 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healing Surgical Wounds
• Surgical Wound

Intervention

Device:
• diathermy
In women undergoing C.S, is healing power after diathermy equally to healing power after scalpel?
• 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.

Locations

Country	Name	City	State
Egypt	Ain shams maternity teaching hospital	Cairo	Abbasia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cosmosis	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.	15 days after CS
Primary	Healing power	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.	15 days after cs
Secondary	postoperative surgical wound pain: VAS scale	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.	24 hours