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 : December 7, 2017
|Condition or disease||Intervention/treatment|
|Surgical Wound Infection||Device: Alexis O-Ring Wound Retractor Other: Standard Surgical Retractors|
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The study design was a randomized controlled study to evaluate wound infection rates in patients undergoing a cesarean delivery. The patients were randomized into two sub- groups; the first group received routine hand-held metal retractors as needed by the surgical team, and the second group received an Alexis Wound Retractor. Inclusion criteria included: maternal age of at least 18 years, a gestational age of at least 24 0/7 wks by best obstetric estimate, a viable gestation, a non-emergent cesarean delivery, and a planned transverse skin incision. Deliveries included: primary cesarean for failed induction, maternal request, or other obstetric indications; and repeat cesarean deliveries that were elective or had obstetric indications (such as spontaneous labor in a subject with a term gestation and with history of 2 or more prior cesarean deliveries). Exclusion criteria included chorioamnionitis, chronic corticosteroid therapy, a prior abdominal vertical skin incision scar or planned vertical incision, history of a prior wound infection or separation, a planned cesarean hysterectomy, or maternal or fetal complications requiring an emergent delivery.
Randomization was done using a web-based randomization generator. Variables were allocated as: 1 for Alexis, and 0 for conventional surgical retractors. Packages including consent forms, data sheets, and the randomized allocation were prepared for the entire study and were stored in one office. Study packets were prepared to include a sealed envelope indicating randomization to be opened after the consent form was signed. Only after randomization, the Alexis retractor was opened and placed on the surgical field.
Prior to initiation of the study, in-service sessions were conducted with OB surgical teams to facilitate the use of the retractors. Information provided included optimal use of the retractor and selection of the appropriate retractor size. The primary surgeon of each case was previously trained by the principle investigator in placement of the retractor on actual patients.
Once a decision was made to proceed with cesarean delivery, the subject was approached and offered to participate in the study. After the patient had been enrolled and consent forms signed, an allocated envelope for each study subject determined which arm of the study to which the patient would be randomized; no other management decisions was made as part of the RCT. Surgical decisions were independent of the patient's designated study arm and retractor type. Such decisions included: type of anesthesia, length of transverse skin incision , method of tissue dissection (blunt vs. instrumental), creation of bladder flap, size and nature of uterine incision (transverse, low vertical, classical, J-type, T-incision), surgical material used, exteriorization of the uterus, manual vs. spontaneous delivery of placenta, layer closure techniques (bladder flap, peritoneum, subcutaneous tissue), and skin closure technique (staples, subcuticular sutures). Skin preoperative preparation was performed as standard with ChloraPrep® Applicator (2% Chlorhexidine gluconate and 70% isopropyl alcohol). Intravenous antibiotics were given preoperatively in accordance to national guidelines (12). The primary outcome of this study was the development of a surgical site infection after cesarean delivery within two weeks after cesarean.
Incisions were checked daily in-house. However, the exams that were used in this study to determine the occurrences of SSI were the first exam done in the outpatient setting for removal of staples (post op days 5 - 7), and the two week post partum visit (post op days 14 - 18). SSIs were diagnosed according to the Centers for Disease Control and Prevention (CDC) criteria.(13). The most commonly seen characteristics were purulent drainage or localized swelling and/or redness of the surgical wound.
In addition, other wound complications were also assessed and included: seroma (wounds with clear drainage) and/or hematomas. Other secondary outcomes included skin time to uterine incision (minutes) , exteriorization of the uterus(yes, no) , total operative time (minutes), estimated blood loss (mL) estimated by the primary surgeon, and postoperative pain based on a subjective 1-10 pain scale, assessed 4 times daily while hospitalized and at the outpatient visits previously mentioned.
An initial sample size estimate was performed using the frequentist approach with an assumption of power 80% and Type 1 error = 5% (2-sided). The primary outcome of the study is expected to occur in 15% of women in the "usual care" group. In order to detect a 50% reduction (15% to 7.5%) in the rate of wound complications with the use of the Alexis retractor, a total sample size of 564 women will be needed (282 per group). The planned study was to be carried out at two distinct sites: the University of Texas Medical Branch in Galveston (UTMB) and the University of Texas in Houston. The Institutional Review Board of UTMB-Galveston IRB # 10-188 approved the study.
|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
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|