Efficacy of Using a Closing Pack to Reduce Postpartum Sepsis

Prevention of Postpartum Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05632705
• Other study ID #: PPS trial 2
• Status: Completed
• Phase: N/A
• Start date: March 8, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: November 2022
• Source: University of Pretoria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomised trial comparing the efficacy and feasibility of using a sterile closing pack to reduce postpartum sepsis

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: April 30, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prevention of Postpartum Sepsis
• Puerperal Infection
• Sepsis

Intervention

Other:
• Closing pack
A closing pack, new sterile gloves and new sterile drapes will be used when commencing closure of the sheath and skin

Locations

Country	Name	City	State
South Africa	Kalafong Provincial Tertiary Hospital	Pretoria	Gauteng Province

Sponsors (1)

Lead Sponsor	Collaborator
University of Pretoria

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy to reduce surgical site infections within seven days	Incidence of surgical site infections in both arms	Seven days post-operatively
Secondary	Efficacy to reduce postpartum endometritis within seven days	Incidence of postpartum endometritis in both arms	Seven days post-operatively
Secondary	Feasibility of using a closure pack	Assess the availability as well as use of the sterile closing pack	At the time of caesarean section