Clinical trial NCT02493608: Scalpel vs Diathermy in Repeat Cesarean Delivery
Official title: Scalpel vs Diathermy in Making Abdominal Wall Incision During Repeat Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complications; Cesarean Section
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2015-07-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incision Time .
timeFrame: during surgery
Secondary outcomes:
measure: Post Operative Pain
timeFrame: Post Operative Day (POD) 1 and Day 2
measure: Blood Loss
timeFrame: Blood lost during incision/surgery
Other outcomes:
Locations:
city: Odessa
country: United States
facility: Medical Center Hospital
state: Texas
Study officials:
affiliation: Texas Tech University
name: Martin Caliendo, M.D
role: PRINCIPAL_INVESTIGATOR
References: