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Efficacy of Diathermy on Healing Power of Cesarean Section Scar (EDHPCS)

Primary Purpose

Healing Surgical Wounds

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
diathermy
scalpel
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Healing Surgical Wounds

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Ain shams maternity teaching hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

diathermy group

scalpel group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

postoperative surgical wound pain: VAS scale
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.

Full Information

First Posted
June 11, 2019
Last Updated
January 19, 2020
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT03988972
Brief Title
Efficacy of Diathermy on Healing Power of Cesarean Section Scar
Acronym
EDHPCS
Official Title
Efficacy of Diathermy on Healing Power of Cesarean Section Scar:A Randomized Control Trail
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 6, 2019 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healing Surgical Wounds

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Care ProviderInvestigator
Masking Description
allocation done by a person not involved in the study.
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
diathermy group
Arm Type
Experimental
Arm Description
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
Arm Title
scalpel group
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
diathermy
Other Intervention Name(s)
electro-cautrey
Intervention Description
In women undergoing C.S, is healing power after diathermy equally to healing power after scalpel?
Intervention Type
Device
Intervention Name(s)
scalpel
Intervention Description
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 Outcome Measure Information:
Title
Cosmosis
Description
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.
Time Frame
15 days after CS
Title
Healing power
Description
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.
Time Frame
15 days after cs
Secondary Outcome Measure Information:
Title
postoperative surgical wound pain: VAS scale
Description
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.
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed abd elfatah elsenity, lecturer
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain shams maternity teaching hospital
City
Cairo
State/Province
Abbasia
ZIP/Postal Code
11591
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
will be shared in amaster sheet

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Efficacy of Diathermy on Healing Power of Cesarean Section Scar

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