Recruiting

Abdominal Closure Bundle

Sponsor:

Abington Memorial Hospital

Code:

NCT03500055

Conditions

Surgical Site Infection

Cesarean Section; Infection

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Abdominal Closure Bundle

Study Details

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

Study ID

NCT03500055

Start date

Jun 1, 2018

Status verified date

Jul, 2018

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

850 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

no intervention: Control

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

Interventions

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

Primary outcome measure

  • Surgical Site Infection [ Time Frame: Within 30 days of procedure. ]

Central Contacts and Locations

Central contacts

Shaina F Bruce, MD

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

Preethi Rajendran, MD

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

Locations

Abington Hospital-Jefferson Health

Recruiting

Abington, Pennsylvania, United States, 19001

Contacts

Shaina F Bruce, MD

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

Preethi Rajendran, MD

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

More Information

Sponsor

Abington Memorial Hospital

Last update posted

Jul 5, 2018

Last verified

Jul, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abington Memorial Hospital on 2018-07-05.