Clinical trial NCT03988972: Efficacy of Diathermy on Healing Power of Cesarean Section Scar
Official title: Efficacy of Diathermy on Healing Power of Cesarean Section Scar:A Randomized Control Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healing Surgical Wounds
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-06-18
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cosmosis
timeFrame: 15 days after CS
measure: Healing power
timeFrame: 15 days after cs
Secondary outcomes:
measure: postoperative surgical wound pain: VAS scale
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams maternity teaching hospital
state: Abbasia
Study officials:
affiliation: Ain Shams University
name: Mohamed abd elfatah elsenity, lecturer
role: PRINCIPAL_INVESTIGATOR
References: