Impact of Preoperative Bathing on Post Caesarean Section Surgical Site Infection

Not Applicable

Completed

• Conditions: Cesarean Wound Disruption With Postnatal Complication
• Interventions: Other: preoperative bathing with antiseptic

• Registration Number: NCT03544710
• Lead Sponsor: Mbarara University of Science and Technology

Brief Summary

Surgical site infection (SSI) is the commonest hospital-acquired infection globally, and prevalence is much higher in the low-income countries. Caesarean delivery carries a 5-20 fold risk for developing postpartum sepsis. SSIs cause significant morbidity, prolonged hospitalization and mortality. Simple and inexpensive interventions like preoperative bathing need to be studied, to assess their impact on surgical site infection rates.

Detailed Description

Caesarean delivery is the single-most important risk factor for postpartum pregnancy associated infections carrying a 5 to 20-fold increase in the risk of developing sepsis. Research done in MRRH showed a post-surgery wound sepsis prevalence of 82% on all surgical wards in the hospital and the prevalence of post caesarean section wound infection at MRRH is 15.5%. At MRRH, surgical site infections remain a substantial cause of morbidity, prolonged hospitalization and mortality. SSI is associated with a mortality rate of 3%, and 75% of SSI associated deaths are directly attributable to the SSIs. Universal practices like preoperative bathing of patients are currently not being practiced at MRRH and thus their impact on reducing the burden can only be speculated upon. The aim of this study was to assess the impact of preoperative bathing with chloroxylenol antiseptic on the incidence of post caesarean section surgical site infection.

Study Timeline

• Study Start: 2017-12-07
• Primary Completion: 2018-02-21
• Study Completion: 2018-03-21
• Status Verified: 2018-05
• Study First Submitted: 2018-05-20
• Study First Submitted QC: 2018-05-31
• Last Update Submitted: 2018-05-31
• Study First Posted: 2018-06-04
• Last Update Posted: 2018-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 96

Inclusion Criteria

• All mother scheduled for delivery by emergency C/S at MRRH during the study period.

Exclusion Criteria

• Women who declined to consent.
• Women with obvious evidence of infection, like fever, foul-smelling liquor, or those already on antibiotics for reasons other than preoperative prophylaxis.
• Women in whom delivery was indicated to occur within less than 30 minutes, like in fetal distress, obstructed labor, pulsatile cord prolapse, or ruptured uterus.
• Women who could not communicate and give information for the study and those who do not have a working telephone contact.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bathing	preoperative bathing with antiseptic	Intervention was Preoperative bathing with antiseptic. Given warm water and a tablet soap containing chloroxylenol antiseptic. Asked to bathe under supervision for standardization. Given a clean theatre gown to put on. Taken through the routine pre-operative preparation procedures which involved; Putting an intravenous cannula; administering prophylactic antibiotics. Administering intravenous normal saline 1 liter. taking off a blood sample (3mls) for blood grouping and cross matching. Putting urethral catheter for drainage of urine, Getting an informed consent from the client for the procedure to be done. Informing the theatre team.

Primary Outcome Measures

Name	Time	Method
Surgical site infection	30 days	Clinical diagnosis was made based on the CDC- 2013 definition of SSI

Trial Locations

Locations (1)

Mbarara University of Science and Technology; 🇺🇬 Mbarara, Uganda