Efficacy of Using a Closing Pack to Reduce Postpartum Sepsis

Sponsor

University of Pretoria (Other)

Overall Status

Completed

CT.gov ID

NCT05632705

Collaborator

(none)

1,000

Enrollment

Location

Arms

13.7

Actual Duration (Months)

72.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Prevention of Postpartum Sepsis	Other: Closing pack	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomised trialRandomised trial

Masking:

Single (Outcomes Assessor)

Masking Description:

The outcomes assessor will not have information with regards to the intervention arms

Primary Purpose:

Prevention

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

Actual Study Start Date :

Mar 8, 2021

Actual Primary Completion Date :

Jan 31, 2022

Actual Study Completion Date :

Apr 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Efficacy to reduce surgical site infections within seven days [Seven days post-operatively]
Incidence of surgical site infections in both arms

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kalafong Provincial Tertiary Hospital	Pretoria	Gauteng Province	South Africa

Sponsors and Collaborators

University of Pretoria

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Leon Snyman, Prof, University of Pretoria

ClinicalTrials.gov Identifier:

NCT05632705

Other Study ID Numbers:

PPS trial 2

First Posted:

Nov 30, 2022

Last Update Posted:

Nov 30, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sepsis

Puerperal Infection

Study Results

No Results Posted as of Nov 30, 2022