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Completed

NCT Number: NCT02493608

Scalpel vs Diathermy in Repeat Cesarean Delivery

The objective of this study is to compare scalpel vs. diathermy in abdominal wall incision in pregnant patients undergoing repeat elective cesarean delivery.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical Center Hospital

Odessa, Texas, 79763, United States

About this study

It is hypothesized that wall incisions made by diathermy compared to scalpel during repeat cesarean delivery will have less incision time, as well as less blood loss. A second hypothesis is that the use of diathermy, compared with scalpel will not increase in post-operative pain.

  • This is a randomized prospective study in women undergoing elective repeat cesarean delivery at Medical Center Hospital in Odessa Texas.
  • Women undergoing cesarean delivery will be randomized into two groups: One group will undergo diathermy to incise the entire abdominal wall ,which includes skin, subcutaneous tissue, rectus muscle until the peritoneal cavity is visible. On the other group scalpel will be used to achieve the same aim.
  • A standardized abdominal wall incision will be made with either diathermy in cut mode or scalpel. Diathermy will be set in a cut mode with standard setting as per surgeons preference. All patients in the study will get standard skin incision in terms of length and depth which will be marked by a ruler.
  • Incision time ( measured in minutes and seconds with stop watch) and amount of bleeding will be measured. Blood loss will be calculated by weighing (in grams) the "used" lap sponges and comparing this to the weight (in grams0 of "fresh" lap sponges.
  • Post-operative pain will be measured by a Visual Analogue Scale (VAS). Measurements will be taken at 6:00 to 7:00 AM from post -op day 1 until hospital discharge.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Multiparous pregnant women 18 - 45 years.
  • Gestational ages 37 weeks to 41 weeks,
  • Undergoing repeat elective or repeat emergency cesarean deliveries.

Exclusion criteria

  • Informed consent can't be obtained in a manner that allows for no impression of undue influence/pressure or sufficient time for patient to consider participation.
  • Primary Cesarean deliveries - as these can bias the selection.
  • Skin conditions such as infections, psoriasis, and eczema.

Treatment and study plan

Scalpel

Device

used to cut the abdominal wall.

Other names: Blade

Diathermy

Device

Diathermy used to cut , coagulate the tissue

Other names: Bovie

Primary outcomes

  1. Incision Time .

    Time frame: during surgery

    Time to make an abdominal wall incision from skin to rectus fascia.

Secondary outcomes

  1. Post Operative Pain

    Time frame: Post Operative Day (POD) 1 and Day 2

    Done by VAS scale. Visual Analog Scale to measure pain. Scale range from 0 to 10 with higher values indicating worse pain.

  2. Blood Loss

    Time frame: Blood lost during incision/surgery

    Blood lost during incision/surgery

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center

Other

Registry information

Official study title

Scalpel vs Diathermy in Making Abdominal Wall Incision During Repeat Cesarean Delivery

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 9, 2015
Registry last updated
Mar 24, 2020

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.

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