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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
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Wound Infection focused on measuring Surgical Site Infection, Cesarean delivery infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    June 9, 2015
    Last Updated
    October 17, 2018
    Sponsor
    The University of Texas Medical Branch, Galveston
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    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
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    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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