Alexis O-Ring Wound Retractor for the Prevention of Post-cesarean Surgical Site Infections (Alexis)
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|ClinicalTrials.gov Identifier: NCT03365219|
Recruitment Status : Completed
First Posted : December 7, 2017
Last Update Posted : May 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Surgical Wound Infection||Device: Alexis O-Ring Wound Retractor Other: Standard Surgical Retractors||Not Applicable|
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|
|Actual Primary Completion Date :||October 2013|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|