Surgical Site Infection Clinical Trial
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
NCT number | NCT03500055 |
Other study ID # | 18-016 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2018 |
Est. completion date | December 2019 |
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.
Status | Recruiting |
Enrollment | 850 |
Est. completion date | December 2019 |
Est. primary completion date | December 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Abington Hospital-Jefferson Health | Abington | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Abington Memorial Hospital |
United States,
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. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Surgical Site Infection | Definitions per 2017 CDC definitions | Within 30 days of procedure. | |
Secondary | Risk factors for surgical site infection | Will collect demographic, obstetrical, and surgical characteristics and determine specific risk factors for surgical site infection in these patients. | Within 30 days of procedure. |
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