Efficacy of Using a Closing Pack to Reduce Postpartum Sepsis

Not Applicable

Completed

• Conditions: Prevention of Postpartum Sepsis
• Interventions: Other: Closing pack

• Registration Number: NCT05632705
• Lead Sponsor: University of Pretoria

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 Timeline

• Study Start: 2021-03-08
• Study First Submitted: 2021-03-08
• Primary Completion: 2022-01-31
• Study Completion: 2022-04-30
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-21
• Last Update Submitted: 2022-11-21
• Study First Posted: 2022-11-30
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	Closing pack	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.

Primary Outcome Measures

Name	Time	Method
Efficacy to reduce surgical site infections within seven days	Seven days post-operatively	Incidence of surgical site infections in both arms

Secondary Outcome Measures

Name	Time	Method
Efficacy to reduce postpartum endometritis within seven days	Seven days post-operatively	Incidence of postpartum endometritis in both arms
Feasibility of using a closure pack	At the time of caesarean section	Assess the availability as well as use of the sterile closing pack

Trial Locations

Locations (1)

Kalafong Provincial Tertiary Hospital; 🇿🇦 Pretoria, Gauteng Province, South Africa