Kalafong Provincial Tertiary Hospital
Pretoria, Gauteng, South Africa
Completed
NCT Number: NCT05632705
Efficacy of Using a Closing Pack to Reduce Postpartum Sepsis
Randomised trial comparing the efficacy and feasibility of using a sterile closing pack to reduce postpartum sepsis
Completed
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Closing pack
OtherA closing pack, new sterile gloves and new sterile drapes will be used when commencing closure of the sheath and skin
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
-
Efficacy to reduce postpartum endometritis within seven days
Time frame: Seven days post-operatively
Incidence of postpartum endometritis in both arms
-
Feasibility of using a closure pack
Time frame: At the time of caesarean section
Assess the availability as well as use of the sterile closing pack
Sponsors and collaborators
Lead sponsor
University of Pretoria
Other
Registry information
Official study 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
Important dates
- Study start
- 2021
- Primary completion
- 2022
- Study completion
- 2022
- First posted
- Nov 30, 2022
- Registry last updated
- Nov 30, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.