Scalpel vs Diathermy in Repeat Cesarean Delivery

Texas Tech University Health Sciences Center

Status: Completed

Conditions: Complications; Cesarean Section

Treatments: Device: scalpel; Device: Diathermy

Study type: Interventional

Funder types: Other

Identifiers

NCT02493608

L15-144

Details and patient eligibility

About

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

Full description

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.

1. This is a randomized prospective study in women undergoing elective repeat cesarean delivery at Medical Center Hospital in Odessa Texas.
2. 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.
3. 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.
4. 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.
5. 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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

scalpel group

Active Comparator group

Description:

Scalpel is the device used to make abdominal wall incision in this group of patient.

Treatment:

Device: scalpel

Diathermy group

Active Comparator group

Description:

In this study group, abdominal wall incisions are made with diathermy which is a electrosurgical instrument.

Treatment:

Device: Diathermy