Safe Hands at the Sharp End- Implementing Aseptic Technique in the Operating Room

NCT02983136 | Completed

• 1 other identifier: Safe Hands
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this integrated Knowledge Translation (iKT) study is to develop and test a multifaceted implementation intervention for feasibility, acceptability and effectiveness. The intervention will be tailored to fit the context of the operating room (OR), to promote OR team members' use of aseptic techniques during the care of frail persons undergoing acute fracture surgery of the hip. Through the use of an iKT approach, the investigators hypothesise that building on leadership support, partnership between researchers, managers/clinical leaders and healthcare professionals, a solid foundation for the sustained implementation of patient safety innovations can be created.

Conditions

Surgical Wound Infection

Keywords

Hand Hygiene; Implementation; Partnership; Surgery

Outcome Measures

Primary Outcomes (1)

• Surgical site infections

  At discharge, after 6 weeks and 1 year data will be collect on post-operative infections.

  1 year

Secondary Outcomes (1)

• Hand hygiene and Aseptic techniques

  At baseline, 6, 12 and 18 month after the start of the intervention

Other Outcomes (1)

• Process evaluation

  1 year

Study Arms (2)

Study site

EXPERIMENTAL

The study arm will consist of managers and staff at at the operating department of a University hospital in western Sweden' The intervention is based on partnership, dialogue and inter-professional learning

Behavioral: Dialogue and inter-professional learning

Control site

NO INTERVENTION

The Control arm will consist of managers and staff at at the operating department of a University hospital in south Sweden

Interventions

Dialogue and inter-professional learning BEHAVIORAL

The middle and front-line leaders of the study OR will participate in an intervention based on an iKT model. Components of the intervention will include: * Two workshops, consisting of educational sessions covering the state of the art regarding person-centeredness, prevention of infections, leadership, and implementation. The educational component and results of pre-studies will work as frameworks for the dialogues between the front-line leaders and the research group. In dialogues the participants will be given the opportunity to reflect on barriers to and enablers of change; and * The participants will be supported in creating an action plan aimed at facilitating the anaesthesia providers' change of practice.

Study site

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patient that are undergoing hip fracture surgery at the control and study site and have given informed consent

You may not qualify if:

• ongoing infection before surgery

Sponsors & Collaborators

• Göteborg University: lead
• University of Gothenburg Center for Person-Centred Care, GPCC: collaborator
• Landstingens Ömsesidiga Försäkringsbolag (Löf): collaborator

Study Sites (1)

Sahlgrenska Academy, University of Gothenburg

Gothenburg, 405 30, Sweden

Location

Related Publications (2)

• Erichsen Andersson A, Gillespie BM, Karlsson M, Malchau H, Nellgard B, Wikstrom E, Rogmark C, Tillander J. Reduction of early surgical site and other care related infections in 3553 hip fracture patients: lessons learned from the 5-year Safe Hands project. Antimicrob Resist Infect Control. 2022 Sep 5;11(1):113. doi: 10.1186/s13756-022-01153-4.

  PMID: 36064457 DERIVED

• Erichsen Andersson A, Frodin M, Dellenborg L, Wallin L, Hok J, Gillespie BM, Wikstrom E. Iterative co-creation for improved hand hygiene and aseptic techniques in the operating room: experiences from the safe hands study. BMC Health Serv Res. 2018 Jan 4;18(1):2. doi: 10.1186/s12913-017-2783-1.

  PMID: 29301519 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: December 6, 2016
• Study Start: May 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: January 4, 2019

Record last verified: 2019-01

Locations

SE (1)