- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03544710
Impact of Preoperative Bathing on Post Caesarean Section Surgical Site Infection (SSI-MUST)
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Mbarara, Uganda
- Mbarara University of Science and Technology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surgical site infection
Time Frame: 30 days
|
Clinical diagnosis was made based on the CDC- 2013 definition of SSI
|
30 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Henry Lukabwe, MD, Mbarara University of Science and Technology
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08/08-17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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