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Trial details
Preoperative Chlorhexidine Gluconate Bathing Could Prevent Post-obstetric and gynecologic Surgical-site Infections: A Pilot for a Randomized Controlled Trial
Current status:
Approved
|
Date registered:
24/12/2019
|
Date last updated:
24/12/2019
Trial version(s)
Current: 19/12/2019
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2019121361
Protocol number
HD2305
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
20/12/2019
Primary sponsor
Beirut Arab University
Primary sponsor: Country of origin
Lebanon
Public title
Preoperative Chlorhexidine Gluconate Bathing Could Prevent Post-obstetric and gynecologic Surgical-site Infections: A Pilot for a Randomized Controlled Trial
Acronym
Scientific title
Preoperative Chlorhexidine Gluconate Bathing Could Prevent Post-obstetric and gynecologic Surgical-site Infections: A Pilot for a Randomized Controlled Trial
Acronym
Brief summary of the study: English
Background: Bathing with chlorhexidine gluconate is a novel practice that reduces the microbial burden on skin. There is limited data on chlorhexidine gluconate bathing in obstetric and gynecological surgeries in Lebanon. Objective: To test the feasibility of a randomized controlled trial through a pilot design to evaluate the effect of preoperative chlorhexidine gluconate bathing on reducing surgical-site infections in obstetric and gynecological surgeries involving abdominal incisions. Methods: Participants will be randomized into the intervention or usual care group. Participants in the intervention group will bath with 4% chlorhexidine gluconate sponge on the day of the surgery. They will apply the product between the upper two-thirds of the thighs and abdomen just below the breasts for 5 minutes. The rest of the body will be bathed normally as usual care. The bathing will be consistent by all participants. While participants in the usual care group will be left to practice what the healthcare facility usually advises them to do. Outcomes will be collected at day 10 and 30 after the surgery for surgical site infections defined by the presence of pus in the wound in addition to possible redness, warmth, discharge or dehisces in the wound or infectious morbidity such as fever or abdominal pain.
Brief summary of the study: Arabic
هذه الدراسة تختبر تأثير استخدام كلورهيكسيدين جلوكونيت في التعقيم قبل اجراء العمليات الجراحية التوليدية والمتعلقة بأمراض النساء على خفض احتمال حدوث الالتهابات في منطقة الجرح. سينقسم المشتركون في الدراسة عشوائياً الى مجموعتين، حيث ستستخدم مجوعة منهم الكلورهيكسيدين في تعقيم المنطقة ما بين البطن وحتى ثلثي الفخدين، والأخرى ستستخدم الأساليب التقليدية في التعقيم لدى المستشفى. أما النتائج، فستجمع بعد 10 و 30 يوم من تاريخ إجراء العملية لوجود اي مؤشر للالتهابات.
Health conditions/problem studied: Specify
Infection post-surgery on the surgical site
Interventions: Specify
A daily visit to the named hospitals will be done by Researcher I to check the following day’s operating room schedule for any planned OBS/GYN abdominal surgeries. Participants with planned surgeries will be approached upon admission and introduced to the study. Each participant will be allocated to a study code. Participants will sign the consent form and complete the baseline questionnaire. They will then be randomized based on their study code. Participants allocated to the intervention group will be instructed by Researcher I on the use of CHG before leaving to the surgery. CHG will be provided to the participants to perform the bath. Participants will be instructed to emphasize the CHG application between the upper two-thirds of the thighs and abdomen just below the breasts for 5 minutes. The rest of the body will be bathed normally as usual care. Same instructions will be given to all participants in the intervention group by the same researcher to assure consistency. Tools and figures will be used to enhance explanation. Adherence to intervention will be assured when giving the antiseptic and asking to bath immediately.
Key inclusion and exclusion criteria: Inclusion criteria
Adult women presenting to the hospitals OBS/GYN pre-surgery wards during the study period; they will be included if they were presented for a planned surgery, consenting to participate and will be available for follow up, regardless of their nationality.
Key inclusion and exclusion criteria: Gender
Female
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
45
Key inclusion and exclusion criteria: Exclusion criteria
Participants will be excluded if they have known allergy to chlorhexidine or have a condition impeding them from participation such as blindness, deafness or cognitive impairment.
Type of Study
Type
Interventional
Type of intervention
Educations programs
Trial scope
Prophylaxis
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Open (masking not used)
Study design: Control
Placebo
Study phase
0 (explanatory trials)
Study design: Purpose
Prevention
Study design: Assignment
Parallel
Pharmaceutical class
Chlorhexidine is a broad-spectrum antiseptic effective against Gram-positive and negative bacteria (WHO, 2008).
Therapeutic indication
CHG reduces microbial colonization on the skin, and thus, is used in many of the hospitals to reduce the risk of having health-care associated infections.
Therapeutic benefit
Chlorhexidine is used for disinfection instead of Betadine in many of the hospitals, but its effect has not yet been established in reducing the risk of infection; therefore, this trial is being conducted to evaluate its effect on reducing the risk of post-operative infections in the site of the surgical wound.
Biospecimen retention
None retained
Biospecimen description
WBC will be assessed after 10 days from surgery to detect any presence of infections.
Target sample size
40
Actual enrollment target size
Date of first enrollment: Type
Anticipated
Date of first enrollment: Date
03/02/2020
Date of study closure: Type
Anticipated
Date of study closure: Date
29/05/2020
Recruitment status
Pending
Date of completion
29/05/2020
IPD sharing statement plan
No
IPD sharing statement description
Data will be shared if the reviewers find it necessary to maintain confidentiality and avoid the risk of breathing confidential data that may be identifiable due to the small sample size and the small community.
Additional data URL
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Beirut Arab University
01300110
Sources of Monetary or Material Support
Name
Dr. Hiba Deek
Ms. Nour Shbaklo
Secondary Sponsors
Name
none
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Hiba
Deek
Beirut
Lebanon
01300110
h.deek@bau.edu.lb
BAU
Scientific
Hiba
Deek
Beirut
Lebanon
01300110
h.deek@bau.edu.lb
BAU
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Rafic Hariri University Hospital
Ms. Nour Shbaklo
Infection Prevention and Control
Approved
Makassed General Hospital
Ms. Nour Shbaklo
Infection Prevention and Control
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Rafic Hariri University Hospital
26/12/2018
Mrs. Abir Sinno
abir.sinno@crurhuh.com
00000000
Makassed General Hospital
18/12/2018
Ms. Loubna
research.makassed@hotmail.com
00000000
Countries of Recruitment
Name
Lebanon
Health Conditions or Problems Studied
Condition
Code
Keyword
infection
Infection of obstetric surgical wound (O86.0)
infection
Interventions
Intervention
Description
Keyword
Use of CHG in bathing prior to surgery
Bathing with CHG from abdomen until two-thirds of the thighs
CHG
Primary Outcomes
Name
Time points
Measure
Infection
10 and 30 days
inspection and blood tests
Key Secondary Outcomes
Name
Time points
Measure
none
none
none
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Download as PDF
Save a PDF copy of the summary of the trial