Efficacy of Diathermy on Healing Power of Cesarean Section Scar

NCT ID: NCT03988972

Last Updated: 2020-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-06

Study Completion Date

2019-08-01

Brief Summary

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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

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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.

Conditions

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Healing Surgical Wounds

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

DOUBLE

Caregivers Investigators
allocation done by a person not involved in the study.

Study Groups

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diathermy group

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

Group Type EXPERIMENTAL

diathermy

Intervention Type DEVICE

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

scalpel group

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.

Group Type ACTIVE_COMPARATOR

scalpel

Intervention Type 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.

Interventions

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diathermy

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

Intervention Type DEVICE

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.

Intervention Type DEVICE

Other Intervention Names

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electro-cautrey

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed abd elfatah elsenity

Lecturer of obstetrics and gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed abd elfatah elsenity, lecturer

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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Ain shams maternity teaching hospital

Cairo, Abbasia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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27180413

Identifier Type: -

Identifier Source: org_study_id

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