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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
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Surgical Wound Infection Device: Alexis O-Ring Wound Retractor Other: Standard Surgical Retractors

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 564 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. Estimated blood loss [ Time Frame: intraoperative assessment ]
    Defined as the amount of blood loss during the cesarean delivery as estimated by the operating surgeons.

  3. 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

  4. 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.


Other Outcome Measures:
  1. 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

  2. Gestational age at time of delivery [ Time Frame: at time of delivery ]
    Completed gestational age in weeks

  3. Infant weight [ Time Frame: At time of delivery ]
    Infant Weight in kg

  4. Type of gestation [ Time Frame: Noted at the time of delivery ]
    Singleton or multiple fetus

  5. 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


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

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


Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
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
More Information

Additional Information:
Publications:

Responsible Party: Gayle Olson Koutravelis, Principle Investigator, The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT03365219     History of Changes
Other Study ID Numbers: 10-188
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gayle Olson Koutravelis, The University of Texas Medical Branch, Galveston:
Surgical Site Infection
Cesarean delivery infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Wounds and Injuries
Surgical Wound Infection
Wound Infection
Surgical Wound
Postoperative Complications
Pathologic Processes