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Completed

NCT Number: NCT03544710

Impact of Preoperative Bathing on Post Caesarean Section Surgical Site Infection

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.

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Key information

Age range

15 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mbarara University of Science and Technology

Mbarara, Uganda

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

preoperative bathing with antiseptic

Other

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.

Primary outcomes

  1. Surgical site infection

    Time frame: 30 days

    Clinical diagnosis was made based on the CDC- 2013 definition of SSI

Sponsors and collaborators

Lead sponsor

Mbarara University of Science and Technology

Other

Registry information

Official study 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

Acronym: SSI-MUST

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 4, 2018
Registry last updated
Jun 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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