Alexis O-Ring Wound Retractor for the Prevention of Post-cesarean Surgical Site Infections (Alexis)
Primary Purpose
Surgical Wound Infection
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Alexis O-Ring Wound Retractor
Standard Surgical Retractors
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Wound Infection focused on measuring Surgical Site Infection, Cesarean delivery infection
Eligibility Criteria
Inclusion Criteria:
- 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
- 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:
- chorioamnionitis
- chronic corticosteroid therapy
- prior abdominal vertical skin incision scar or planned vertical incision
- history of a prior wound infection or separation
- planned cesarean hysterectomy
- maternal or fetal complications requiring an emergent delivery
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Alexis Retractor
Standard Surgical Retractors
Arm Description
This group received an Alexis O-Ring Wound Retractor during cesarean delivery.
This group received routine hand-held metal retractors as needed by the surgical team during cesarean delivery.
Outcomes
Primary Outcome Measures
Surgical Site Infection
Assessed as present or absent. Defined as the development of wound infection, seroma, or other wound disruption in patients who underwent a cesarean delivery
Secondary Outcome Measures
Postoperative pain
Patients are asked to report pain on a scale of 1-10, 1 no pain and 10 the worst pain.
Estimated blood loss
Defined as the amount of blood loss during the cesarean delivery as estimated by the operating surgeons.
Uterus exteriorization
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
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.
Full Information
NCT ID
NCT03365219
First Posted
June 9, 2015
Last Updated
October 17, 2018
Sponsor
The University of Texas Medical Branch, Galveston
1. Study Identification
Unique Protocol Identification Number
NCT03365219
Brief Title
Alexis O-Ring Wound Retractor for the Prevention of Post-cesarean Surgical Site Infections
Acronym
Alexis
Official Title
Alexis O-Ring Wound Retractor for the Prevention of Post-cesarean Surgical Site Infections: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 2010 (Actual)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Medical Branch, Galveston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Post cesarean section surgical site infection (SSI) is a common complication that can affect patient recovery and overall outcome. Several approaches have been studied to improve SSI rates such as timing of antibiotic administration and skin preparation. Alexis retractors have been suggested as a reasonable option to decrease SSI. However, to date there is only one randomized controlled study assessing its efficacy. The aim of this study is to whether Alexis wound retractors are beneficial in preventing cesarean section SSI.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound Infection
Keywords
Surgical Site Infection, Cesarean delivery infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
564 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alexis Retractor
Arm Type
Experimental
Arm Description
This group received an Alexis O-Ring Wound Retractor during cesarean delivery.
Arm Title
Standard Surgical Retractors
Arm Type
Active Comparator
Arm Description
This group received routine hand-held metal retractors as needed by the surgical team during cesarean delivery.
Intervention Type
Device
Intervention Name(s)
Alexis O-Ring Wound Retractor
Intervention Description
A flexible self-retaining plastic Alexis retractor was used in place of standard surgical retractors.
Intervention Type
Other
Intervention Name(s)
Standard Surgical Retractors
Intervention Description
Routine hand-held metal retractors as needed by the surgical team
Primary Outcome Measure Information:
Title
Surgical Site Infection
Description
Assessed as present or absent. Defined as the development of wound infection, seroma, or other wound disruption in patients who underwent a cesarean delivery
Time Frame
Time of surgery up to 14 post operative days
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
Patients are asked to report pain on a scale of 1-10, 1 no pain and 10 the worst pain.
Time Frame
Time of surgery up to 14 post operative days
Title
Estimated blood loss
Description
Defined as the amount of blood loss during the cesarean delivery as estimated by the operating surgeons.
Time Frame
intraoperative assessment
Title
Uterus exteriorization
Description
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
Time Frame
intraoperative assessment
Title
Total operative time
Description
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.
Time Frame
intraoperative assessment
Other Pre-specified Outcome Measures:
Title
Apgar scores
Description
Score given by pediatrician or pediatric provider to each infant at 1 and 5 minutes of life
Time Frame
Assessed in every infant at 1 minute and 5 minutes of life
Title
Gestational age at time of delivery
Description
Completed gestational age in weeks
Time Frame
at time of delivery
Title
Infant weight
Description
Infant Weight in kg
Time Frame
At time of delivery
Title
Type of gestation
Description
Singleton or multiple fetus
Time Frame
Noted at the time of delivery
Title
Maternal hypertension
Description
Systolic blood pressure greater than 140 and diastolic blood pressure greater than 90 mmHG
Time Frame
At the time of delivery until 14 days after delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
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:
chorioamnionitis
chronic corticosteroid therapy
prior abdominal vertical skin incision scar or planned vertical incision
history of a prior wound infection or separation
planned cesarean hysterectomy
maternal or fetal complications requiring an emergent delivery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gayle L Olson, MD
Organizational Affiliation
University of Texas Medical Branch in Galveston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
George Saade, MD
Organizational Affiliation
University of Texas Medical Branch in Galveston
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20334736
Citation
Menacker F, Hamilton BE. Recent trends in cesarean delivery in the United States. NCHS Data Brief. 2010 Mar;(35):1-8.
Results Reference
background
PubMed Identifier
10580621
Citation
Kirkland KB, Briggs JP, Trivette SL, Wilkinson WE, Sexton DJ. The impact of surgical-site infections in the 1990s: attributable mortality, excess length of hospitalization, and extra costs. Infect Control Hosp Epidemiol. 1999 Nov;20(11):725-30. doi: 10.1086/501572.
Results Reference
background
PubMed Identifier
16260325
Citation
Stone PW, Braccia D, Larson E. Systematic review of economic analyses of health care-associated infections. Am J Infect Control. 2005 Nov;33(9):501-9. doi: 10.1016/j.ajic.2005.04.246.
Results Reference
background
PubMed Identifier
3847906
Citation
Moir-Bussy B, Hutton R, Thompson J. Wound infection after caesarean section. Nurs Times. 1985 Jun 5-11;81(23):suppl 13-4. No abstract available.
Results Reference
background
PubMed Identifier
20171756
Citation
Rauk PN. Educational intervention, revised instrument sterilization methods, and comprehensive preoperative skin preparation protocol reduce cesarean section surgical site infections. Am J Infect Control. 2010 May;38(4):319-23. doi: 10.1016/j.ajic.2009.10.004. Epub 2010 Feb 19.
Results Reference
background
PubMed Identifier
15913620
Citation
Schneid-Kofman N, Sheiner E, Levy A, Holcberg G. Risk factors for wound infection following cesarean deliveries. Int J Gynaecol Obstet. 2005 Jul;90(1):10-5. doi: 10.1016/j.ijgo.2005.03.020.
Results Reference
background
PubMed Identifier
10711546
Citation
Tran TS, Jamulitrat S, Chongsuvivatwong V, Geater A. Risk factors for postcesarean surgical site infection. Obstet Gynecol. 2000 Mar;95(3):367-71. doi: 10.1016/s0029-7844(99)00540-2.
Results Reference
background
PubMed Identifier
15118648
Citation
Weiss JL, Malone FD, Emig D, Ball RH, Nyberg DA, Comstock CH, Saade G, Eddleman K, Carter SM, Craigo SD, Carr SR, D'Alton ME; FASTER Research Consortium. Obesity, obstetric complications and cesarean delivery rate--a population-based screening study. Am J Obstet Gynecol. 2004 Apr;190(4):1091-7. doi: 10.1016/j.ajog.2003.09.058.
Results Reference
background
PubMed Identifier
14754687
Citation
Cedergren MI. Maternal morbid obesity and the risk of adverse pregnancy outcome. Obstet Gynecol. 2004 Feb;103(2):219-24. doi: 10.1097/01.AOG.0000107291.46159.00.
Results Reference
background
PubMed Identifier
21606770
Citation
ACOG Practice Bulletin No. 120: Use of prophylactic antibiotics in labor and delivery. Obstet Gynecol. 2011 Jun;117(6):1472-1483. doi: 10.1097/AOG.0b013e3182238c31. No abstract available.
Results Reference
background
PubMed Identifier
10196487
Citation
Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site Infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control. 1999 Apr;27(2):97-132; quiz 133-4; discussion 96.
Results Reference
background
PubMed Identifier
22568647
Citation
Cheng KP, Roslani AC, Sehha N, Kueh JH, Law CW, Chong HY, Arumugam K. ALEXIS O-Ring wound retractor vs conventional wound protection for the prevention of surgical site infections in colorectal resections(1). Colorectal Dis. 2012 Jun;14(6):e346-51. doi: 10.1111/j.1463-1318.2012.02943.x.
Results Reference
result
Links:
URL
http://www.hesonline.nhs.uk/Ease/servlet/ContentServer?siteID=1937
Description
NHS Information Centre. HES online: maternity data
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Alexis O-Ring Wound Retractor for the Prevention of Post-cesarean Surgical Site Infections
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