NCT05632705

Efficacy of Using a Closing Pack to Reduce Postpartum Sepsis

A Randomised Trial to Evaluate the Efficacy and Feasibility of a Closing Pack to Reduce the Rate of Surgical Site Infection Following Caesarean Section

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (actual)
• Sponsor: University of Pretoria · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prevention of Postpartum Sepsis

Interventions

Type	Name	Description
OTHER	Closing pack	A closing pack, new sterile gloves and new sterile drapes will be used when commencing closure of the sheath and skin

Timeline

• Start date: 2021-03-08
• Primary completion: 2022-01-31
• Completion: 2022-04-30
• First posted: 2022-11-30
• Last updated: 2022-11-30

Locations

1 site across 1 country: South Africa