Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202108717887402 Date of Approval: 24/08/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Clean-CS
Official scientific title CheckList Expansion for Antisepsis and iNfection Control in Cesarean Section – CLEAN-CS: A Cluster-Randomized, Stepped Wedge Interventional Trial to Reduce Postoperative Infections Following Cesarean Delivery
Brief summary describing the background and objectives of the trial CLEAN-CS is cluster-randomized stepped wedge interventional study to evaluate a multimodal, adaptive program to reduce surgical infections following cesarean delivery. Cesarean section (CS) is the single most common surgical procedure performed worldwide. In Ethiopia, estimates suggest that CS accounts for 30-50% of all operations performed. Population-based work indicates that CS rates of up to 19% are demonstrably related to improved maternal and neonatal survival. The national CS rate per live births was 1.9% in 2016, but rates are highly variable by region. In addition, complications are common, and gynecological and obstetric surgical interventions are associated with high rates of morbidity. Infections and complications following CS are estimated to cause 15% of maternal deaths in the country, and the overall SSI rate following CS is estimated at 9%. Failure to administer preoperative antibiotics has been highlighted as a particular improvement opportunity, and is one of the critical processes this program will focus on. Lifebox, a charity devoted to improving surgical and anesthesia safety, developed a program to improve compliance with the WHO Surgical Safety Checklist and improve adherence to critical standards of perioperative infection prevention. This initiative, called Clean Cut, is an adaptive, multimodal surgical infection prevention program that integrates perioperative process improvement and patient outcomes measurement using process mapping, training and improved management practices, and compliance with critical standards of surgical antisepsis. The program was the result of a joint collaboration between the Ethiopian Federal Ministry of Health (FMOH), the Surgical Society of Ethiopia, and Lifebox and resulted in a 35% relative risk reduction in postoperative infections. The primary aim is to reduce postoperative infections following CS. Secondary aims include reducing complications and improving compliance with best practices.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CLEANCS
Disease(s) or condition(s) being studied Infections and Infestations,Obstetrics and Gynecology,Pregnancy and Childbirth,Surgery
Sub-Disease(s) or condition(s) being studied Complications following cesarean section,Surgical infections
Purpose of the trial Quality improvement, safety, implementation strategies
Anticipated trial start date 01/08/2021
Actual trial start date 16/08/2021
Anticipated date of last follow up 10/03/2023
Actual Last follow-up date 31/01/2023
Anticipated target sample size (number of participants) 7200
Actual target sample size (number of participants) 10506
Recruitment status Closed to recruitment,follow-up continuing
Publication URL https://www.lifebox.org/cleancs/
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group None daily 9 months Clean Cut focuses on improving compliance with six critical perioperative infection prevention standards: - appropriate skin preparation of the surgeon’s hands and the surgical site - maintenance of the sterile field by ensuring the integrity and sterility of surgical gowns, drapes, and gloves - confirmation of instrument sterility - appropriate antibiotic administration - complete swab counts - routine use of the WHO Surgical Safety Checklist Clean Cut is implemented in five phases: 1. Identification of a Clean Cut team to include members from all perioperative disciplines: Ob/Gyn, surgery, nursing, anesthesia, QI personnel and operating room (OR) management; 2. Establishment of a data collection system to track surgical infections and outcomes and understanding context and facility readiness; 3. Modification and implementation of the WHO Surgical Safety Checklist to fit local practices and process mapping the six perioperative standards; 4. Data feedback to connect baseline data with process maps, coupled with site-specific action plans for improvement; 5. Targeted training, workshops, and refresher courses using local providers, coupled with a transition to hospital management for sustaining the program. Clean Cut has been adapted specifically for obstetric and gynecological operations and will be implemented in ten maternity hospitals/departments in Ethiopia in order to reduce infections and other complications for women undergoing cesarean delivery and other obstetric and gynecologic operations. CLEAN-CS will test the core elements of the improvement aspects of Clean Cut, namely steps 3, 4, and 5 above, by randomly assigning the start of this part of the program as part of the stepped intervention testing strategy. 3600 Active-Treatment of Control Group
Experimental Group Clean Cut Daily 9 months Clean Cut focuses on improving compliance with six critical perioperative infection prevention standards: - appropriate skin preparation of the surgeon’s hands and the surgical site - maintenance of the sterile field by ensuring the integrity and sterility of surgical gowns, drapes, and gloves - confirmation of instrument sterility - appropriate antibiotic administration - complete swab counts - routine use of the WHO Surgical Safety Checklist Clean Cut is implemented in five phases: 1. Identification of a Clean Cut team to include members from all perioperative disciplines: Ob/Gyn, surgery, nursing, anesthesia, QI personnel and operating room (OR) management; 2. Establishment of a data collection system to track surgical infections and outcomes and understanding context and facility readiness; 3. Modification and implementation of the WHO Surgical Safety Checklist to fit local practices and process mapping the six perioperative standards; 4. Data feedback to connect baseline data with process maps, coupled with site-specific action plans for improvement; 5. Targeted training, workshops, and refresher courses using local providers, coupled with a transition to hospital management for sustaining the program. Clean Cut has been adapted specifically for obstetric and gynecological operations and will be implemented in ten maternity hospitals/departments in Ethiopia in order to reduce infections and other complications for women undergoing cesarean delivery and other obstetric and gynecologic operations. CLEAN-CS will test the core elements of the improvement aspects of Clean Cut, namely steps 3, 4, and 5 above, by randomly assigning the start of this part of the program as part of the stepped intervention testing strategy. 3600
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
As obstetric and gynecologic operations are typically undertaking in separate, dedicated operating theatres, we will focus our prospective observations on patients admitted to these theatres. Any patient undergoing surgery at any time in one of the targeted operating theatres is eligible for inclusion; there will be no exclusion criteria. Enrollment will occur at the time of observation and will include various times (day and night) and days of the week (weekdays and weekends). As the standards being implemented are not in dispute and are considered critical for ensuring antisepsis and sterility, patient informed consent will not be obtained. While our focus will be on cesarean delivery, any obstetric or gynecological operation will be included, with the inclusion of other operations in this populations (such as appendectomy for appendicitis that is found incidentally or misdiagnosed as ovarian torsion, for example). There will be no age range limit. None Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 13 Year(s) 99 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/06/2021 National Research Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Ministry of Science and Higher Education Addis Ababa Addis Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Surgical infections following cesarean delivery: Number of patients undergoing cesarean delivery diagnosed with postoperative infection in hospital or up to 30 days post surgery; measured by change pre and post intervention In hospital and 30 days following surgery
Secondary Outcome Compliance with infection prevention practices: Number of patients undergoing obstetric and gynecologic surgery receiving each of the six perioperative infection prevention and control practices defined by the Clean Cut program; measured by change pre and post intervention during surgery
Secondary Outcome Surgical infections following obstetric and gynecologic operations: Number of patients undergoing obstetric and gynecologic operations diagnosed with postoperative infection in hospital or up to 30 days post surgery; measured by change pre and post intervention in hospital and at 30 days
Secondary Outcome Reoperation following obstetric and gynecologic surgery: Number of patients requiring reoperation or return to the operating theatre prior to discharge following obstetric and gynecologic surgery; measured by change pre and post intervention in hospital
Secondary Outcome Length of Stay: Mean and median length of stay, in days, following following obstetric and gynecologic surgery; measured by change pre and post intervention on discharge
Secondary Outcome Postoperative maternal mortality: Number of mothers who die in hospital or up to 30 days following CS; measured by change pre and post intervention in hospital and at 30 days
Secondary Outcome Neonatal mortality: Number of newborn/fetal deaths prior to discharge of mother following cesarean delivery; measured by change pre and post intervention in hospital
Secondary Outcome Atlas/MKA Facility Readiness Toolkit scores: Comparison of facility characteristics including assessments of Commitment and Motivation, Ability to Implement, Internal Culture, Clinical Team Functionality, and Knowledge and Ability to engage in quality improvement programs in surgery as measured by the Atlas/MKA Facility Readiness Toolkit throughout study
Secondary Outcome Postoperative mortality: Number of women who die in hospital or up to 30 days following obstetric and gynecologic surgery; measured by change pre- and post-intervention in hospital and at 30 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lifebox Foundation Gulf Aziz Building, near Edna Mall, Ste. 205 Addis Ababa Addis Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
UBS Optimus Foundation unknown New York United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Bill and Melinda Gates Foundation Gates Foundation Seattle United States of America Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Ethiopian Society of Obstetricians and Gynecologists ESOG headquarters Addis Ababa Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Thomas Weiser tweiser@stanford.edu +16507230172 300 Pasteur Dr, H3638
City Postal code Country Position/Affiliation
Stanford 94305 United States of America Associate Professor
Role Name Email Phone Street address
Public Enquiries Kitty Jenkins kitty@lifebox.org +440000000 21 Portland Place
City Postal code Country Position/Affiliation
London W1B 1PY United Kingdom Head of Communications
Role Name Email Phone Street address
Scientific Enquiries Tihitena Negussie tihitena.negussie@lifebox.org +2150000000 Addis Ababa
City Postal code Country Position/Affiliation
Addis Ababa Addis Ethiopia Associate Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share data based on all reasonable requests using deidentified data. Statistical Analysis Plan,Study Protocol Within 3 months of trial publication All reasonable requests will be considered
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.lifebox.org/cleancut No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information