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

NCT03500055 | Unknown DMC

• 1 other identifier: 18-016
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection; Cesarean Section; Infection

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection

  Definitions per 2017 CDC definitions

  Within 30 days of procedure.

Secondary Outcomes (1)

• Risk factors for surgical site infection

  Within 30 days of procedure.

Study Arms (2)

Abdominal Closure Bundle

EXPERIMENTAL

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

Control

NO INTERVENTION

Normal operative procedure. The abdominal closure bundle will not be used.

Interventions

Abdominal Closure Bundle PROCEDURE

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

Abdominal Closure Bundle

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abington Memorial Hospital: lead

Study Sites (1)

Abington Hospital-Jefferson Health

Abington, Pennsylvania, 19001, United States

RECRUITING

Related Publications (5)

• 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.

  PMID: 27955845 BACKGROUND

• 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.

  PMID: 28734498 BACKGROUND

• 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.

  PMID: 25788822 BACKGROUND

• 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.

  PMID: 28885421 BACKGROUND

• 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.

  PMID: 29548786 BACKGROUND

Related Links

• 2017 CDC Surgical Site Infection Guidelines

MeSH Terms

Conditions

Surgical Wound Infection; Infections

Condition Hierarchy (Ancestors)

Wound Infection; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shaina F Bruce, MD

CONTACT

215-481-7915; shaina.bruce@jefferson.edu

Preethi Rajendran, MD

CONTACT

215-481-7884; preethi.rajendran@jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident physician

Model Details: Single center, randomized controlled trial

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 17, 2018
• Study Start: June 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 5, 2018

Record last verified: 2018-07

Locations

US (1)