Impact of Preoperative Bathing on Post Caesarean Section Surgical Site Infection

Cesarean Wound Disruption With Postnatal Complication Clinical Trial

— SSI-MUST  

Official title:

The Impact of Preoperative Bathing With Chloroxylenol on the Incidence of Post Caesarean Section Surgical Site Infection at Mbarara Regional Referral Hospital: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03544710
• Other study ID #: 08/08-17
• Status: Completed
• Phase: N/A
• Start date: December 7, 2017
• Est. completion date: March 21, 2018

Study information

• Verified date: May 2018
• Source: Mbarara University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: March 21, 2018
• Est. primary completion date: February 21, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Wound Disruption With Postnatal Complication
• Infection
• Surgical Wound Infection

Intervention

Other:
• preoperative bathing with antiseptic
Preoperative bathing with antiseptic was done as follows; 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.

Locations

Country	Name	City	State
Uganda	Mbarara University of Science and Technology	Mbarara

Sponsors (1)

Lead Sponsor	Collaborator
Mbarara University of Science and Technology

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infection	Clinical diagnosis was made based on the CDC- 2013 definition of SSI	30 days