A Randomised Trial to Evaluate the Efficacy and Feasibility of a Closing Pack to Reduce the Rate of Surgical Site Infection Following Caesarean Section
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pretoria
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Efficacy to reduce surgical site infections within seven days
Study Overview
Brief Summary
Randomised trial comparing the efficacy and feasibility of using a sterile closing pack to reduce postpartum sepsis
Detailed Description
Pregnant patients meeting the inclusion criteria undergoing elective or emergency caesarean section will be eligible for recruitment. Patients will be randomised into two arms. In the control arm sheath and skin closure will be performed with the instruments used to perform the caesarean section, as per the current standard of care. In the intervention arm, after suturing the uterine incision and obtaining hemostasis and before commencing closure of the sheath and skin, the surgical team (obstetrician, assistant and scrub sister) will don clean sterile gloves, open clean sterile linen to drape on top of the existing linen and open a pack of clean sterile instruments to close the sheath and skin.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
The outcomes assessor will not have information with regards to the intervention arms
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •women 18 years and older willing and able to provide consent
Exclusion Criteria
- •women who are not able or willing to provide consent patients with existing maternal infection
Arms & Interventions
Intervention arm
In this arm, prior to closing the sheath and skin, unused drapes, gloves and instruments will be used to close the sheath and the skin.
Intervention: Closing pack (Other)
Control arm
In this arm sheath and skin closure will be according to the standard protocol
Outcomes
Primary Outcomes
Efficacy to reduce surgical site infections within seven days
Time Frame: Seven days post-operatively
Incidence of surgical site infections in both arms
Secondary Outcomes
- Feasibility of using a closure pack(At the time of caesarean section)
- Efficacy to reduce postpartum endometritis within seven days(Seven days post-operatively)
Investigators
Leon Snyman
Prof
University of Pretoria