Scalpel vs Diathermy in Repeat Cesarean Delivery
Scalpel vs Diathermy in Making Abdominal Wall Incision During Repeat Cesarean Delivery
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 6, 2015
CompletedFirst Posted
Study publicly available on registry
July 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedResults Posted
Study results publicly available
February 28, 2020
CompletedMarch 24, 2020
March 1, 2020
1.9 years
July 6, 2015
February 26, 2020
March 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Incision Time .
Time to make an abdominal wall incision from skin to rectus fascia.
during surgery
Secondary Outcomes (2)
Post Operative Pain
Post Operative Day (POD) 1 and Day 2
Blood Loss
Blood lost during incision/surgery
Study Arms (2)
scalpel group
ACTIVE COMPARATORScalpel is the device used to make abdominal wall incision in this group of patient.
Diathermy group
ACTIVE COMPARATORIn this study group, abdominal wall incisions are made with diathermy which is a electrosurgical instrument.
Interventions
Eligibility Criteria
You may qualify if:
- Multiparous pregnant women 18 - 45 years.
- Gestational ages 37 weeks to 41 weeks,
- Undergoing repeat elective or repeat emergency cesarean deliveries.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical Center Hospital
Odessa, Texas, 79763, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chadley Copeland
- Organization
- Texas Tech Health Sciences Center
Study Officials
- PRINCIPAL INVESTIGATOR
Martin Caliendo, M.D
Texas Tech University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2015
First Posted
July 9, 2015
Study Start
July 1, 2015
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
March 24, 2020
Results First Posted
February 28, 2020
Record last verified: 2020-03