Clean-CS: A Program to Improve the Safety of C-section

NCT04812522 | Completed

• 1 other identifier: Clean-CS
• Study Type: interventional
• Target: 10,506
• Locations: 1 country
• Sites: 10

Brief Summary

Executive summary: Cesarean delivery, or section (CS), is the single most common surgical procedure performed. Estimates indicate that in low resource settings, CS comprises up to 50% of more of the total volume of operations performed. The World Health Organization recommends national CS rates of between 10-15% to save lives and improve maternal and neonatal outcomes. Population-based work indicates that CS rates of up to 19% are demonstrably related to improved maternal and neonatal survival. However, complications are common, and gynecological and obstetric surgical interventions are associated with high rates of morbidity. In low resource settings, complication rates are particularly high. The intervention being tested is based on a previously developed program called Clean Cut. 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. It was successfully piloted in five surgical departments in Ethiopia, and reduced the relative risk of infection by 35%. This has been adapted specifically for obstetric and gynecological operations and will be evaluated in a cluster randomized stepped wedge trial design 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.

Conditions

Cesarean Section Complications

Keywords

maternal health; emergency obstetric and neonatal care; surgical infections; quality improvement

Outcome Measures

Primary Outcomes (1)

• 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

  18 months

Secondary Outcomes (7)

• Surgical infections following obstetric and gynecologic operations

  18 months

• Compliance with infection prevention practices

  18 months

• Reoperation following obstetric and gynecologic surgery

  18 months

• Length of Stay

  18 months

• Postoperative maternal mortality

  18 months

Other Outcomes (1)

• Atlas/MKA Facility Readiness Toolkit score

  24 months

Study Arms (5)

Clean Cut intervention - Cluster 1

OTHER

Cluster 1 will receive the Clean Cut infection prevention intervention at random time point "A"

Behavioral: Clean Cut program

Clean Cut intervention - Cluster 2

OTHER

Cluster 2 will receive the Clean Cut infection prevention intervention at random time point "B"

Behavioral: Clean Cut program

Clean Cut intervention - Cluster 3

OTHER

Cluster 3 will receive the Clean Cut infection prevention intervention at random time point "C"

Behavioral: Clean Cut program

Clean Cut intervention - Cluster 4

OTHER

Cluster 4 will receive the Clean Cut infection prevention intervention at random time point "D"

Behavioral: Clean Cut program

Clean Cut intervention - Cluster 5

OTHER

Cluster 5 will receive the Clean Cut infection prevention intervention at random time point "E"

Behavioral: Clean Cut program

Interventions

Clean Cut program BEHAVIORAL

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

Clean Cut intervention - Cluster 1; Clean Cut intervention - Cluster 2; Clean Cut intervention - Cluster 3; Clean Cut intervention - Cluster 4; Clean Cut intervention - Cluster 5

Eligibility Criteria

• Gender Eligibility Details: women undergoing obstetric or gynecological operations
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• The Lifebox Foundation: lead
• Ethiopian Society of Obstetricians and Gynecologists: collaborator

Study Sites (10)

Alert Hospital

Addis Ababa, Ethiopia

Location

Ras Desta Hospital

Addis Ababa, Ethiopia

Location

Adare General Hospital

Awasa, Ethiopia

Location

Yirgalem General Hospital

Awasa, Ethiopia

Location

Ambo University Referral Hospital

Āmbo, Ethiopia

Location

Assela University Hospital

Āsela, Ethiopia

Location

Dil Chora Referral Hospital

Dire Dawa, Ethiopia

Location

Wolaita Sodo University Hospital

Sodo, Ethiopia

Location

Wolkite University Specialized Hospital

Welk’īt’ē, Ethiopia

Location

Werabe Comprehensive Specialized Hospital

Worabe, Ethiopia

Location

Related Publications (15)

• Forrester JA, Koritsanszky L, Parsons BD, Hailu M, Amenu D, Alemu S, Jiru F, Weiser TG. Development of a Surgical Infection Surveillance Program at a Tertiary Hospital in Ethiopia: Lessons Learned from Two Surveillance Strategies. Surg Infect (Larchmt). 2018 Jan;19(1):25-32. doi: 10.1089/sur.2017.136. Epub 2017 Nov 14.

  PMID: 29135348 BACKGROUND

• Garland NY, Kheng S, De Leon M, Eap H, Forrester JA, Hay J, Oum P, Sam Ath S, Stock S, Yem S, Lucas G, Weiser TG. Using the WHO Surgical Safety Checklist to Direct Perioperative Quality Improvement at a Surgical Hospital in Cambodia: The Importance of Objective Confirmation of Process Completion. World J Surg. 2017 Dec;41(12):3012-3024. doi: 10.1007/s00268-017-4198-x.

  PMID: 29038828 BACKGROUND

• Foster D, Kethman W, Cai LZ, Weiser TG, Forrester JD. Surgical Site Infections after Appendectomy Performed in Low and Middle Human Development-Index Countries: A Systematic Review. Surg Infect (Larchmt). 2018 Apr;19(3):237-244. doi: 10.1089/sur.2017.188. Epub 2017 Oct 23.

  PMID: 29058569 BACKGROUND

• Cai LZ, Foster D, Kethman WC, Weiser TG, Forrester JD. Surgical Site Infections after Inguinal Hernia Repairs Performed in Low and Middle Human Development Index Countries: A Systematic Review. Surg Infect (Larchmt). 2018 Jan;19(1):11-20. doi: 10.1089/sur.2017.154. Epub 2017 Oct 19.

  PMID: 29048997 BACKGROUND

• Weiser TG, Haynes AB, Molina G, Lipsitz SR, Esquivel MM, Uribe-Leitz T, Fu R, Azad T, Chao TE, Berry WR, Gawande AA. Size and distribution of the global volume of surgery in 2012. Bull World Health Organ. 2016 Mar 1;94(3):201-209F. doi: 10.2471/BLT.15.159293.

  PMID: 26966331 BACKGROUND

• Molina G, Weiser TG, Lipsitz SR, Esquivel MM, Uribe-Leitz T, Azad T, Shah N, Semrau K, Berry WR, Gawande AA, Haynes AB. Relationship Between Cesarean Delivery Rate and Maternal and Neonatal Mortality. JAMA. 2015 Dec 1;314(21):2263-70. doi: 10.1001/jama.2015.15553.

  PMID: 26624825 BACKGROUND

• Weiser TG, Gawande A. Excess Surgical Mortality: Strategies for Improving Quality of Care. In: Debas HT, Donkor P, Gawande A, Jamison DT, Kruk ME, Mock CN, editors. Essential Surgery: Disease Control Priorities, Third Edition (Volume 1). Washington (DC): The International Bank for Reconstruction and Development / The World Bank; 2015 Apr 2. Chapter 16. Available from http://www.ncbi.nlm.nih.gov/books/NBK333498/

  PMID: 26740999 BACKGROUND

• Weiser TG, Forrester JD, Forrester JA. Tactics to Prevent Intra-Abdominal Infections in General Surgery. Surg Infect (Larchmt). 2019 Feb/Mar;20(2):139-145. doi: 10.1089/sur.2018.282. Epub 2019 Jan 10.

  PMID: 30628859 BACKGROUND

• Rickard J, Beilman G, Forrester J, Sawyer R, Stephen A, Weiser TG, Valenzuela J. Surgical Infections in Low- and Middle-Income Countries: A Global Assessment of the Burden and Management Needs. Surg Infect (Larchmt). 2020 Aug;21(6):478-494. doi: 10.1089/sur.2019.142. Epub 2019 Dec 9.

  PMID: 31816263 BACKGROUND

• Mattingly AS, Starr N, Bitew S, Forrester JA, Negussie T, Bereknyei Merrell S, Weiser TG. Qualitative outcomes of Clean Cut: implementation lessons from reducing surgical infections in Ethiopia. BMC Health Serv Res. 2019 Aug 17;19(1):579. doi: 10.1186/s12913-019-4383-8.

  PMID: 31419972 BACKGROUND

• Delisle M, Pradarelli JC, Panda N, Koritsanszky L, Sonnay Y, Lipsitz S, Pearse R, Harrison EM, Biccard B, Weiser TG, Haynes AB; Surgical Outcomes Study Groups and GlobalSurg Collaborative. Variation in global uptake of the Surgical Safety Checklist. Br J Surg. 2020 Jan;107(2):e151-e160. doi: 10.1002/bjs.11321.

  PMID: 31903586 BACKGROUND

• Starr N, Gebeyehu N, Tesfaye A, Forrester JA, Bekele A, Bitew S, Wayessa E, Weiser TG, Negussie T. Value and Feasibility of Telephone Follow-Up in Ethiopian Surgical Patients. Surg Infect (Larchmt). 2020 Aug;21(6):533-539. doi: 10.1089/sur.2020.054. Epub 2020 Apr 16.

  PMID: 32301651 BACKGROUND

• Forrester JA, Starr N, Negussie T, Schaps D, Adem M, Alemu S, Amenu D, Gebeyehu N, Habteyohannes T, Jiru F, Tesfaye A, Wayessa E, Chen R, Trickey A, Bitew S, Bekele A, Weiser TG. Clean Cut (adaptive, multimodal surgical infection prevention programme) for low-resource settings: a prospective quality improvement study. Br J Surg. 2021 Jun 22;108(6):727-734. doi: 10.1002/bjs.11997.

  PMID: 34157086 BACKGROUND

• Mammo TN, Feyssa MD, Nofal MR, Gebeyehu N, Shiferaw MA, Tesfaye A, Fikre T, Woldeamanuel H, Alemu SB, Miller K, Haile ST, Weiser TG; Checklist Expansion for Antisepsis and Infection Control in Cesarean Section (CLEAN-CS) Trial Group. A Perioperative Quality Improvement Program for Cesarean Delivery in Ethiopia: A Stepped-Wedge Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2428910. doi: 10.1001/jamanetworkopen.2024.28910.

  PMID: 39163043 DERIVED

• Mammo TN, Feyssa MD, Haile ST, Fikre T, Shiferaw MA, Woldeamanuel H, Temesgen F, Gebeyehu N, Starr N, Fernandez K, Henrich N, Alemu SB, Miller K, Weiser TG. Evaluation of an adaptive, multimodal intervention to reduce postoperative infections following cesarean delivery in Ethiopia: study protocol of the CLEAN-CS cluster-randomized stepped wedge interventional trial. Trials. 2022 Aug 19;23(1):692. doi: 10.1186/s13063-022-06500-9.

  PMID: 35986400 DERIVED

Study Officials

• Thomas G Weiser, MD MPH

  The Lifebox Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consulting Medical Officer

Model Details: cluster randomized stepped wedge design

Study Record Dates

• First Submitted: March 13, 2021
• First Posted: March 23, 2021
• Study Start: August 26, 2021
• Primary Completion: January 31, 2023
• Study Completion: March 10, 2023
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: patient data will be available upon completion of the trial
• Access Criteria: All reasonable requests

Locations

ET (10)