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

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

Study Overview

• Status: Completed
• Conditions: Prevention of Postpartum Sepsis
• Intervention / Treatment: Other: Closing pack

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 Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Gauteng Province
    • Pretoria, Gauteng Province, South Africa
      • Kalafong Provincial Tertiary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Closing pack; A closing pack, new sterile gloves and new sterile drapes will be used when commencing closure of the sheath and skin
No Intervention: Control arm; In this arm sheath and skin closure will be according to the standard protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy to reduce surgical site infections within seven days	Incidence of surgical site infections in both arms	Seven days post-operatively

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Pretoria

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2021
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: March 8, 2021
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pregnancy Complications; Puerperal Disorders; Pregnancy Complications, Infectious; Sepsis; Puerperal Infection
• Other Study ID Numbers: PPS trial 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No