Efficacy of Diathermy on Healing Power of Cesarean Section Scar

NCT03988972 | Completed DMC

• 1 other identifier: 27180413
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Healing Surgical Wounds

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• postoperative surgical wound pain: VAS scale

  24 hours

Study Arms (2)

diathermy group

EXPERIMENTAL

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

Device: diathermy

scalpel group

ACTIVE COMPARATOR

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.

Device: scalpel

Interventions

diathermy DEVICE

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

Also known as: electro-cautrey

diathermy group

scalpel DEVICE

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.

scalpel group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams maternity teaching hospital

Cairo, Abbasia, 11591, Egypt

Location

MeSH Terms

Interventions

Diathermy; Laser Therapy

Intervention Hierarchy (Ancestors)

Hyperthermia, Induced; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Mohamed abd elfatah elsenity, lecturer

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: allocation done by a person not involved in the study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of obstetrics and gynecology

Model Details: The 180 patients who will be included in our study will be randomized through computer generated system in to 2 groups. Group D (diathermy) and group S (scalpel). Each group will include 90 patients. Allocation and concealment will be done by sequentially sealed opaque envelopes. 180 envelopes will be numbered serially from 1 to 180, 90 envelopes will contain the letter D and the other 90 will contain the letter S. In each envelope, the corresponding letter which donates the allocated group will be put according to the randomization table and them all envelopes will be closed and put in one box. When the first patient arrives, the first envelope will be opened and the patient will be allocated according to the letter inside, whom will be allocated by a person not involved in the study.

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 18, 2019
• Study Start: February 6, 2019
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)