Scalpel Versus Diathermy Skin Incision in Repeated CS

NCT ID: NCT04818710

Last Updated: 2021-03-26

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

476 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2021-01-31

Brief Summary

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This study was performed to compare both methods of skin incisions to determine differences in postoperative pain, hemodynamic changes, incisional time, blood loss during incision, wound healing, and wound complication.

Detailed Description

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Our study aims to compare the use of diathermy versus scalpel in making skin incision during cesarean section to judge the variations in

1. incision time,
2. incision blood loss,
3. hemodynamic changes,
4. postoperative pain,
5. wound healing
6. wound complications.

Conditions

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Benifits of Using Diathermy in Skin Incision

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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skin incision with a scalpel

In the scalpel group, the incision was made by the traditional method, with proper homeostasis by applying pressure to skin blood vessels and ligating the subcutaneous bleeding.

Group Type PLACEBO_COMPARATOR

skin incision with a scalpel

Intervention Type PROCEDURE

A Pfannenstiel skin incision was done through the subcutaneous tissue, rectus sheath and dissected from rectus muscle until peritoneum was visualized.

group 1 (skin incision with a scalpel)

skin incision with diathermy

In the diathermy group, the incision made using a small flat blade pen electrode, set on cutting mode and delivering a 120 watt (maximum) sinusoidal current, electrosurgical cutting performed without pressure or mechanical displacement.

Group Type ACTIVE_COMPARATOR

skin incision with diathermy

Intervention Type PROCEDURE

A Pfannenstiel skin incision was done through the subcutaneous tissue, rectus sheath and dissected from rectus muscle until peritoneum was visualized.

group 2 (skin incision with diathermy)

Interventions

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skin incision with a scalpel

A Pfannenstiel skin incision was done through the subcutaneous tissue, rectus sheath and dissected from rectus muscle until peritoneum was visualized.

group 1 (skin incision with a scalpel)

Intervention Type PROCEDURE

skin incision with diathermy

A Pfannenstiel skin incision was done through the subcutaneous tissue, rectus sheath and dissected from rectus muscle until peritoneum was visualized.

group 2 (skin incision with diathermy)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* women with a history of only one previous cesarean section
* age between 18 and 40 years
* gestational age of 38 to 41 weeks
* body mass index less than 30.

Exclusion Criteria

* any medical disorder that can affect wound healing as diabetes, chronic anemia, chronic skin conditions, history of allergy, or history of an infected surgical wound.
* Women who conducted primary or emergency cesarean deliveries
* cardiac patients on pacemakers
* patients on anticoagulants
* women refusing to participate in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role collaborator

National Research Centre, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Mazen Abdel Rasheed

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Research Centre

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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diathermy skin incision

Identifier Type: -

Identifier Source: org_study_id

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