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Trial record 27 of 4109 for:    Recruiting, Not yet recruiting, Available Studies | "Communicable Diseases"

Abdominal Closure Bundle to Reduce Surgical Site Infection in Patients Undergoing C-sections. Cesarean Section Lead to Reduction in Surgical Site Infection? - A Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT03500055
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
Shaina Bruce, Abington Memorial Hospital

Brief Summary:
This study is a single center, randomized controlled trial investigating the use of an abdominal closure bundle to reduce surgical site infection in patients undergoing cesarean section. The abdominal closure bundle consists of surgeon repeat scrub, changing gown and gloves, as well as usage of new instruments for closure of fascia, subcutaneous tissue, and skin. Patients will be randomized to either abdominal closure bundle or normal operative procedure. Primary outcome is surgical site infection within 30 days of procedure.

Condition or disease Intervention/treatment Phase
Surgical Site Infection Cesarean Section; Infection Procedure: Abdominal Closure Bundle Not Applicable

Detailed Description:

All patients, aged 18 years or older, greater than 34 weeks of gestation who will be undergoing a scheduled cesarean section to be performed by Abington Primary Women's Health Care Group, Abington Ob/Gyn Associates, Womencare, Women's Health Care Group, Dr. Ron Hoffman, or the Ob/Gyn Chief Service will be considered for participation in this study. Scheduled cesarean sections include all routine cesarean sections- whether receiving spinal or general anesthesia, as well as patients who present to obstetrical triage in labor or with ruptured membranes who are for cesarean section.

The following patients will be excluded from our study:

  • Unscheduled, STAT or urgent cesarean sections from the labor floor (failure to descend, failure to progress, non-reassuring fetal heart tracing, chorioamnionitis, placental abruption, prolapsed cord, etc.)
  • SOAT (Surgical Operative Assist Team) cesarean sections
  • Gestational age < 34 weeks for any reason
  • Preterm premature rupture of membranes from antepartum unit

As there are no published prospective trials abdominal closure bundles in cesarean sections, sample size calculations were completed using a recently published meta-analysis of multiple retrospective studies.4 These studies investigated various surgical site reduction techniques as applied to cesarean sections. Using this data, which shows an average pre-intervention SSI rate of 6% and post-reduction SSI rate of 2%, to detect a statistically significant reduction, we will need to enroll approximately 850 patients.

Patients will be randomly assigned to receive either normal operative procedure or the closing bundle through a randomized process. Simple randomization in a 1:1 ratio will be completed via Microsoft Excel. Group assignments will be placed in sealed opaque envelopes which will be located on the labor and delivery unit. The envelope will be opened by the resident physician or advanced practice professional who will be assisting with the cesarean section on arrival to the operating room. This will allow the scrub tech to prepare the closing tray prior to the start of the procedure if indicated.

All patients will receive pre-operative antibiotics, chlorhexidine abdominal preparation, thirty second betadine vaginal preparation, hair removal by clippers at the operative site, lower extremity forced air warmer, subcutaneous tissue closure >2cm, subcuticular skin closure, and removal of surgical bandage on post-operative day 2. The abdominal closure bundle includes changing of the surgical gown and gloves, repeat surgical scrub, and usage of new surgical instruments, light handles, suction, and bovie tip for closure of fascia, subcutaneous tissue, and skin. Given the nature of the intervention, the surgeon and patient will not be blinded to group assignment.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 850 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single center, randomized controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Only the primary investigators will be able to be blinded for this study. The surgeon is unable to be blinded and since the patient is awake during c-sections, blinding will be impossible.
Primary Purpose: Prevention
Official Title: Does Implementation of an Abdominal Closure Bundle in Patients Undergoing Scheduled Cesarean Section Lead to Reduction in Surgical Site Infection? - A Randomized Controlled Trial
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: Abdominal Closure Bundle
Surgeons will re-scrub, change gown and gloves prior to closure of fascia. Will also use new instruments, bovie tip, suction tip, and light handles, for closure of fascia, subcutaneous tissue, and skin.
Procedure: Abdominal Closure Bundle
Surgeons will re-scrub, change gown and gloves prior to closure of fascia. Will also use new instruments, bovie tip, suction tip, and light handles, for closure of fascia, subcutaneous tissue, and skin

No Intervention: Control
Normal operative procedure. The abdominal closure bundle will not be used.



Primary Outcome Measures :
  1. Surgical Site Infection [ Time Frame: Within 30 days of procedure. ]
    Definitions per 2017 CDC definitions


Secondary Outcome Measures :
  1. Risk factors for surgical site infection [ Time Frame: Within 30 days of procedure. ]
    Will collect demographic, obstetrical, and surgical characteristics and determine specific risk factors for surgical site infection in these patients.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Greater than 34 weeks of gestation who will be undergoing a scheduled cesarean section to be performed by Abington Primary Women's Health Care Group, Abington Ob/Gyn Associates, Womencare, Women's Health Care Group, Dr. Ron Hoffman, or the Ob/Gyn Chief Service will be considered for participation in this study.
  • Patients who present to obstetrical triage in labor or with ruptured membranes who are for cesarean section are also included in the study.

Exclusion Criteria:

  • Unscheduled, STAT or urgent cesarean sections from the labor floor (failure to descend, failure to progress, non-reassuring fetal heart tracing, chorioamnionitis, placental abruption, prolapsed cord, etc.)
  • SOAT (Surgical Operative Assist Team) cesarean sections
  • Gestational age < 34 weeks for any reason
  • Preterm premature rupture of membranes from antepartum unit

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): NCT03500055


Contacts
Contact: Shaina F Bruce, MD 215-481-7915 shaina.bruce@jefferson.edu
Contact: Preethi Rajendran, MD 215-481-7884 preethi.rajendran@jefferson.edu

Locations
United States, Pennsylvania
Abington Hospital-Jefferson Health Recruiting
Abington, Pennsylvania, United States, 19001
Contact: Shaina F Bruce, MD    215-481-7915    shaina.bruce@jefferson.edu   
Contact: Preethi Rajendran, MD    215-481-7884    preethi.rajendran@jefferson.edu   
Sponsors and Collaborators
Abington Memorial Hospital

Additional Information:
Publications:
Responsible Party: Shaina Bruce, Resident physician, Abington Memorial Hospital
ClinicalTrials.gov Identifier: NCT03500055     History of Changes
Other Study ID Numbers: 18-016
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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