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Completed

NCT Number: NCT04818710

Scalpel Versus Diathermy Skin Incision in Repeated CS

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.

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Key information

Conditions

Benifits of Using Diathermy in Skin Incision

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Research Centre

Cairo, Egypt

About this study

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

  • incision time,
  • incision blood loss,
  • hemodynamic changes,
  • postoperative pain,
  • wound healing
  • wound complications.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

skin incision with a scalpel

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

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)

Primary outcomes

  1. incision time

    Time frame: during surgical operation. the difference between starting skin incision till the rectus sheath was visualized

    We compared incisional time by using a digital clock. The incisional time was established as follows: when skin incision was made, the surgeon called out "start the clock". Once the rectus sheath was visualized, the surgeon calls out "stop the clock". The incision time was the difference between "start" and "stop".

  2. incision blood loss

    Time frame: during surgery

    This was calculated by weighing the swabs pre and postoperatively (1mg = 1ml) after complete hemostasis was achieved.

  3. postoperative pain

    Time frame: during the first day after surgery

    We compared those patients clinically for postoperative pain for 24 hours by visual analog scale (VAS) score, a psychometric response scale, and it is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. It is 11 points numeric scale ranges from "0" representing one pain extreme (e.g., no pain) to "10" representing the other pain extreme (e.g., "pain as bad as you can imagine" or "worst pain imaginable"). This score was recorded for each participant at 2,4,6,8,10,12,24 hours postoperatively.

Secondary outcomes

  1. wound healing

    Time frame: during the first week after surgery

    healing by primary versus secondary intention

  2. wound complications

    Time frame: during the first week after surgery

    like seroma, hematoma, ecchymosis, dehiscence (separation of the subcutaneous tissues with skin), and infection

Sponsors and collaborators

Lead sponsor

National Research Centre, Egypt

Other

Collaborators

  • Kasr El Aini Hospital

Registry information

Official study title

Comparative Study Between Scalpel and Diathermy Skin Incision in Repeated Cesarean Section

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Mar 26, 2021
Registry last updated
Mar 26, 2021

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.