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
Does Implementation of an Abdominal Closure Bundle in Patients Undergoing Scheduled Cesarean Section Lead to Reduction in Surgical Site Infection? - A Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Abington, Pennsylvania, United States, 19001
- Recruiting
- Abington Hospital-Jefferson Health
-
Contact:
- Shaina F Bruce, MD
- Phone Number: 215-481-7915
- Email: shaina.bruce@jefferson.edu
-
Contact:
- Preethi Rajendran, MD
- Phone Number: 215-481-7884
- Email: preethi.rajendran@jefferson.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surgical Site Infection
Time Frame: Within 30 days of procedure.
|
Definitions per 2017 CDC definitions
|
Within 30 days of procedure.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Within 30 days of procedure.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Pellegrini JE, Toledo P, Soper DE, Bradford WC, Cruz DA, Levy BS, Lemieux LA. Consensus Bundle on Prevention of Surgical Site Infections After Major Gynecologic Surgery. J Obstet Gynecol Neonatal Nurs. 2017 Jan-Feb;46(1):100-113. doi: 10.1016/j.jogn.2016.10.003. Epub 2016 Dec 8.
- Schiavone MB, Moukarzel L, Leong K, Zhou QC, Afonso AM, Iasonos A, Roche KL, Leitao MM Jr, Chi DS, Abu-Rustum NR, Zivanovic O. Surgical site infection reduction bundle in patients with gynecologic cancer undergoing colon surgery. Gynecol Oncol. 2017 Oct;147(1):115-119. doi: 10.1016/j.ygyno.2017.07.010. Epub 2017 Jul 19.
- Lachiewicz MP, Moulton LJ, Jaiyeoba O. Pelvic surgical site infections in gynecologic surgery. Infect Dis Obstet Gynecol. 2015;2015:614950. doi: 10.1155/2015/614950. Epub 2015 Feb 18.
- Carter EB, Temming LA, Fowler S, Eppes C, Gross G, Srinivas SK, Macones GA, Colditz GA, Tuuli MG. Evidence-Based Bundles and Cesarean Delivery Surgical Site Infections: A Systematic Review and Meta-analysis. Obstet Gynecol. 2017 Oct;130(4):735-746. doi: 10.1097/AOG.0000000000002249.
- Bruce SF, Carr DN, Burton ER, Sorosky JI, Shahin MS, Naglak MC, Edelson MI. Implementation of an abdominal closure bundle to reduce surgical site infection in patients on a gynecologic oncology service undergoing exploratory laparotomy. Gynecol Oncol. 2018 Jun;149(3):560-564. doi: 10.1016/j.ygyno.2018.03.045. Epub 2018 Mar 14.
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-016
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.