Efficacy of Using a Closing Pack to Reduce Postpartum Sepsis

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

Detailed Description
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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.

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

Conditions
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Prevention of Postpartum Sepsis

Intervention / Treatment
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* Other: Closing pack


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>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<br>* A closing pack, new sterile gloves and new sterile drapes will be used when commencing closure of the sheath and skin<br>|
| No Intervention: Control arm<br>In this arm sheath and skin closure will be according to the standard protocol | |

What is the study measuring?
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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 |