Impact of Preoperative Bathing on Post Caesarean Section Surgical Site Infection (SSI-MUST)

• ClinicalTrials.gov Identifier: NCT03544710
• Recruitment Status: Completed
• First Posted: June 4, 2018
• Last Update Posted: June 4, 2018
• Sponsor: Mbarara University of Science and Technology
• Information provided by (Responsible Party): Mbarara University of Science and Technology

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cesarean Wound Disruption With Postnatal Complication	Other: preoperative bathing with antiseptic	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

Intervention Model Description

The participants in the bathing arm were each given warm water and a tablet of soap containing chloroxylenol antiseptic and they were asked to bathe using it within at most two hours prior to the surgery. After bathing, the participants were given a clean theatre gown to put on, after which they were taken through the routine pre-operative preparation procedures according to the existing ward protocol.

The participants in the control arm were only taken through the routine preoperative preparation procedures according to the existing ward protocol

• Masking: Single (Outcomes Assessor)
• Masking Description: Mothers scheduled to deliver by emergency Caesarean section were randomly assigned to either bathing or routine care arms in a ratio of 1:1. We did simple randomization to either bathing or routine care arm without any blocks. We generated patient group assignments using the computer algorithm (computer-generated list of random numbers). The research assistant who enrolled mothers into the study assigned the study arm by checking from the list of random numbers. The research assistant and the PI, who were on the outcomes assessment arm was not allowed to ask the study participant concerning the allocation arm. Single blinding of PI and one of the research assistants assessing outcomes was done to minimize bias.
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: December 7, 2017
• Actual Primary Completion Date: February 21, 2018
• Actual Study Completion Date: March 21, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Bathing; 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.	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.
No Intervention: No bathing; No intervention done for participants in this arm. They go through the routine ward procedure as below. 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.

Outcome Measures

Primary Outcome Measures :

1. Surgical site infection [ Time Frame: 30 days ]
   Clinical diagnosis was made based on the CDC- 2013 definition of SSI

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 49 Years (Child, Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Uganda

Mbarara University of Science and Technology

Mbarara, Uganda

Sponsors and Collaborators

Mbarara University of Science and Technology

Investigators

• Principal Investigator: Henry Lukabwe, MD; Mbarara University of Science and Technology

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lukabwe H, Kajabwangu R, Mugisha D, Mayengo H, Munyanderu B, Baluku A, Manyang A, Lapat JJ, Banya F, Kayondo M, Mayanja R, Muhumuza J, Bajunirwe F, Ngonzi J. Effectiveness of preoperative bath using chloroxylenol antiseptic soap on the incidence of post emergency cesarean section surgical site infection at Mbarara Regional Referral hospital, Uganda: a randomized controlled trial. Pan Afr Med J. 2022 Feb 2;41:92. doi: 10.11604/pamj.2022.41.92.23687. eCollection 2022.

Hadiati DR, Hakimi M, Nurdiati DS, Masuzawa Y, da Silva Lopes K, Ota E. Skin preparation for preventing infection following caesarean section. Cochrane Database Syst Rev. 2020 Jun 25;6(6):CD007462. doi: 10.1002/14651858.CD007462.pub5.

• Responsible Party: Mbarara University of Science and Technology
• ClinicalTrials.gov Identifier: NCT03544710
• Other Study ID Numbers: 08/08-17
• First Posted: June 4, 2018
• Last Update Posted: June 4, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Data will be shared after obtaining all necessary permission

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mbarara University of Science and Technology:

surgical site infection

Additional relevant MeSH terms:

Infections; Surgical Wound Infection; Wound Infection; Postoperative Complications; Pathologic Processes; Anti-Infective Agents, Local; Anti-Infective Agents