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Completed

NCT Number: NCT03988972

Efficacy of Diathermy on Healing Power of Cesarean Section Scar

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.

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Key information

Conditions

Healing Surgical Wounds

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain shams maternity teaching hospital

Cairo, Abbasia, 11591, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diathermy

Device

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

Other names: electro-cautrey

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.

Primary outcomes

  1. Cosmosis

    Time frame: 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.

  2. Healing power

    Time frame: 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 outcomes

  1. postoperative surgical wound pain: VAS scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Acronym: EDHPCS

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 18, 2019
Registry last updated
Jan 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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