Impact of Preoperative Bathing on Post Caesarean Section Surgical Site Infection

NCT03544710 | Completed

• 1 other identifier: 08/08-17
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Wound Disruption With Postnatal Complication

Keywords

surgical site infection

Outcome Measures

Primary Outcomes (1)

• Surgical site infection

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

  30 days

Study Arms (2)

Bathing

EXPERIMENTAL

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

No bathing

NO INTERVENTION

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.

Interventions

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.

Bathing

Eligibility Criteria

• Age: 15 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All mother scheduled for delivery by emergency C/S at MRRH during the study period.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mbarara University of Science and Technology: lead

Study Sites (1)

Mbarara University of Science and Technology

Mbarara, Uganda

Location

Related Publications (2)

• 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.

  PMID: 35465375 DERIVED

• 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.

  PMID: 32580252 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Anti-Infective Agents, Local

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Henry Lukabwe, MD

  Mbarara University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 20, 2018
• First Posted: June 4, 2018
• Study Start: December 7, 2017
• Primary Completion: February 21, 2018
• Study Completion: March 21, 2018
• Last Updated: June 4, 2018

Record last verified: 2018-05

Locations

UG (1)