search
Back to results

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

Primary Purpose

Cesarean Wound Disruption With Postnatal Complication

Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
preoperative bathing with antiseptic
Sponsored by
Mbarara University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cesarean Wound Disruption With Postnatal Complication focused on measuring surgical site infection

Eligibility Criteria

15 Years - 49 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Mbarara University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Bathing

No bathing

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 20, 2018
Last Updated
May 31, 2018
Sponsor
Mbarara University of Science and Technology
search

1. Study Identification

Unique Protocol Identification Number
NCT03544710
Brief Title
Impact of Preoperative Bathing on Post Caesarean Section Surgical Site Infection
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
December 7, 2017 (Actual)
Primary Completion Date
February 21, 2018 (Actual)
Study Completion Date
March 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mbarara University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Wound Disruption With Postnatal Complication
Keywords
surgical site infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bathing
Arm Type
Experimental
Arm Description
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.
Arm Title
No bathing
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
preoperative bathing with antiseptic
Intervention Description
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 Outcome Measure Information:
Title
Surgical site infection
Description
Clinical diagnosis was made based on the CDC- 2013 definition of SSI
Time Frame
30 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Lukabwe, MD
Organizational Affiliation
Mbarara University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mbarara University of Science and Technology
City
Mbarara
Country
Uganda

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data will be shared after obtaining all necessary permission
Citations:
PubMed Identifier
35465375
Citation
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.
Results Reference
derived
PubMed Identifier
32580252
Citation
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.
Results Reference
derived

Learn more about this trial

Impact of Preoperative Bathing on Post Caesarean Section Surgical Site Infection

We'll reach out to this number within 24 hrs