Alexis O-Ring Wound Retractor for the Prevention of Post-cesarean Surgical Site Infections (Alexis)
|ClinicalTrials.gov Identifier: NCT03365219|
Recruitment Status : Completed
First Posted : December 7, 2017
Last Update Posted : December 7, 2017
|Condition or disease||Intervention/treatment|
|Surgical Wound Infection||Device: Alexis O-Ring Wound Retractor Other: Standard Surgical Retractors|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||564 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Alexis O-Ring Wound Retractor for the Prevention of Post-cesarean Surgical Site Infections: A Randomized Controlled Trial|
|Actual Study Start Date :||October 2010|
|Primary Completion Date :||October 2013|
|Study Completion Date :||October 2013|
Experimental: Alexis Retractor
This group received an Alexis O-Ring Wound Retractor during cesarean delivery.
Device: Alexis O-Ring Wound Retractor
A flexible self-retaining plastic Alexis retractor was used in place of standard surgical retractors.
Active Comparator: Standard Surgical Retractors
This group received routine hand-held metal retractors as needed by the surgical team during cesarean delivery.
Other: Standard Surgical Retractors
Routine hand-held metal retractors as needed by the surgical team
- Surgical Site Infection [ Time Frame: Time of surgery up to 14 post operative days ]Assessed as present or absent. Defined as the development of wound infection, seroma, or other wound disruption in patients who underwent a cesarean delivery
- Postoperative pain [ Time Frame: Time of surgery up to 14 post operative days ]Patients are asked to report pain on a scale of 1-10, 1 no pain and 10 the worst pain.
- Estimated blood loss [ Time Frame: intraoperative assessment ]Defined as the amount of blood loss during the cesarean delivery as estimated by the operating surgeons.
- Uterus exteriorization [ Time Frame: intraoperative assessment ]Quantified as yes or no; defined as whether or not the surgeons' exteriorized the uterus extra-corporally (removed from abdominal cavity) at any time of the cesarean delivery
- Total operative time [ Time Frame: intraoperative assessment ]Defined as the total length of time in minutes required to perform the cesarean delivery from time of initial skin incision to completion of skin closure.
- Apgar scores [ Time Frame: Assessed in every infant at 1 minute and 5 minutes of life ]Score given by pediatrician or pediatric provider to each infant at 1 and 5 minutes of life
- Gestational age at time of delivery [ Time Frame: at time of delivery ]Completed gestational age in weeks
- Infant weight [ Time Frame: At time of delivery ]Infant Weight in kg
- Type of gestation [ Time Frame: Noted at the time of delivery ]Singleton or multiple fetus
- Maternal hypertension [ Time Frame: At the time of delivery until 14 days after delivery ]Systolic blood pressure greater than 140 and diastolic blood pressure greater than 90 mmHG
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365219
|Principal Investigator:||Gayle L Olson, MD||University of Texas Medical Branch in Galveston|
|Study Chair:||George Saade, MD||University of Texas Medical Branch in Galveston|