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Randomised trial comparing the efficacy and feasibility of using a sterile closing pack to reduce postpartum sepsis
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | 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. |
|
| Control arm | No Intervention | In this arm sheath and skin closure will be according to the standard protocol |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closing pack | Other | A closing pack, new sterile gloves and new sterile drapes will be used when commencing closure of the sheath and skin |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Patients who are pregnant undergoing caesarean section
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kalafong Provincial Tertiary Hospital | Pretoria | Gauteng | South Africa |
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Randomised trial
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The outcomes assessor will not have information with regards to the intervention arms
| At the time of caesarean section |