Surgical site infections and antibiotics consumption: a multi-centered cluster-randomized controlled trial of tailored education to promote compliance with guidelines to prevent surgical site infections (WACH)
Organizational Data
- DRKS-ID:
- DRKS00015502
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2018-10-19
- Last update in DRKS:
- 2021-08-30
- Registration type:
- Prospective
Acronym/abbreviation of the study
WACH
URL of the study
No Entry
Brief summary in lay language
In the WACH-trial, interventions to promote health care workers’ compliance with guidelines to prevent surgical site infections (SSI) are evaluated which are tailored based on conceptions from compliance psychology and behaviour change sciences. The rationale for this is that SSI continue to be among the most prevalent nosocomial infections in Germany, and their prevention is critical to the success of surgical procedures. Thus, compliance with SSI-preventive measures as well as its determinants are empirically assessed in the fields of orthopaedics and abdominal surgery in six hospitals in four German states, and analysed in terms of strengths and weaknesses in half of the hospitals. Educational interventions tailored on this basis will then be implemented. Interventions delivered by the WACH-project team (primarily workshops) address relevant stakeholders such as the hygiene team, physician and nursing managers, pharmacists as well as controllers. Interventions or intervention options which are jointly developed in this context then address clinical staff, and are delivered by the abovementioned stakeholders. It is expected that the tailored interventions will lead to higher compliance with SSI-preventive measures compared to “usual care”, and thus to lower rates of SSIs (effectiveness). To evaluate their cost-effectiveness, a health economic evaluation will be performed.
Brief summary in scientific language
In the WACH-trial, interventions to promote health care workers’ compliance with guidelines to prevent surgical site infections (SSI) are evaluated which are tailored based on conceptions from compliance psychology and behaviour change sciences. The rationale for this is that SSIs continue to be among the most prevalent nosocomial infections in Germany, and their prevention is critical to the success of surgical procedures. In the cluster-randomized controlled trial, compliance with SSI-preventive measures as well as its multiple determinants are empirically assessed in the fields of orthopaedics and abdominal surgery in six hospitals in four German states. For half of the hospitals a SWOT-analysis will be performed and educational interventions tailored on this basis will then be implemented. Interventions delivered by the WACH-project team (primarily workshops) address relevant stakeholders such as the hygiene team, physician and nursing managers, pharmacists as well as controllers. Interventions or intervention options which are jointly developed in this context then address clinical staff, and are delivered by the abovementioned stakeholders. It is expected that the tailored interventions will lead to higher compliance with SSI-preventive measures compared to “usual care”, and thus to lower rates of SSIs (effectiveness). To evaluate their cost-effectiveness, a health economic evaluation will be performed.
Health condition or problem studied
- Free text:
- Surgical site infections
- ICD10:
- T81.4 - Infection following a procedure, not elsewhere classified
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Tailored interventions: Psychologically tailored educational stimuli and possibly other interventions (e.g. training sessions or feedback discussions) based on an empirical assessment of compliance determinants.
- Arm 2:
- Usual care interventions
Endpoints
- Primary outcome:
- Guideline compliance rates (incl. antibiotic usage), pre- and postintervention, behavioral observation via standardised checklists and observations sheets (partly existing, partly self-developed) by trained observers
- Secondary outcome:
- Surgical site infections, pre- and postintervention, standard surveillance methods (microbiology; partly existing and partly self-developed questionnaires)
Study Design
- Purpose:
- Prevention
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- N=6 Kliniken im Bundesgebiet
Recruitment period and number of participants
- Planned study start date:
- 2018-10-25
- Actual study start date:
- 2018-10-25
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2021-02-11
- Target Sample Size:
- 600
- Final Sample Size:
- 973
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- no minimum age
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- 1. Number of beds: > 30 2. Surgical specialist hospital with regular stationary execution of abdominal and orthopedic/traumatology surgeries 3. Parts of the AWMF guideline and/or the KRINKO recommendation are already applied
Exclusion Criteria
1. Participation in other (research) projects which influence the endpoints of this evaluation study (as assessed by the principal investigator) 2. Restructuring measures in the next three years (from start of the study) which are relevant to the endpoints of the study and were planned before the study start (as assessed by the principal investigator, examples: planned serious modification/fluctuation of employees, especially in terms of executive leadership, planned modification in the establishment of the AWMF-guideline/KRINKO recommendation.
Addresses
Primary Sponsor
- Address:
- Institut für Hygiene, Krankenhaushygiene und UmweltmedizinProf. Dr. med. Iris Freya ChabernyLiebigstraße 22 (Haus 7)04103 LeipzigGermany
- Telephone:
- +49 (0)341 97-15600
- Fax:
- +49 (0)341 97-15609
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinikum-leipzig.de/einrichtungen/hygiene
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Institut für Hygiene, Krankenhaushygiene und UmweltmedizinProf. Dr. med. Iris Freya ChabernyLiebigstraße 22 (Haus 7)04103 LeipzigGermany
- Telephone:
- +49 (0)341 97-15600
- Fax:
- +49 (0)341 97-15609
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinikum-leipzig.de/einrichtungen/hygiene
Contact for Public Queries
- Address:
- Institut für Hygiene, Krankenhaushygiene und UmweltmedizinProf. Dr. med. Iris Freya ChabernyLiebigstraße 22 (Haus 7)04103 LeipzigGermany
- Telephone:
- +49 (0)341 97-15600
- Fax:
- +49 (0)341 97-15609
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinikum-leipzig.de/einrichtungen/hygiene
Principal Investigator
- Address:
- Institut für Hygiene, Krankenhaushygiene und UmweltmedizinProf. Dr. med. Iris Freya ChabernyLiebigstraße 22 (Haus 7)04103 LeipzigGermany
- Telephone:
- +49 (0)341 97-15600
- Fax:
- +49 (0)341 97-15609
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinikum-leipzig.de/einrichtungen/hygiene
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Bundesverwaltungsamt für das Bundesministerium für Gesundheit (Förderkennzeichen: ANNIE2016-55-038)Eupener Straße 12550933 KölnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Geschäftsstelle der Ethik-Kommission an der Medizinischen Fakultät der Universität Leipzig c/o Zentrale PoststelleLiebigstraße 1804103 LeipzigGermany
- Telephone:
- +49-341-9715490
- Fax:
- +49-341-9715499
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://home.uni-leipzig.de/ethik
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2018-01-23
- Ethics committee number:
- 034/18-ek
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2018-02-22
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
- Other secondary IDs:
- ANNIE2016-55-038 - Förderkennzeichen der Finanzierungsquelle (Bundesverwaltungsamt für das Bundesministerium für Gesundheit)
- Other secondary IDs:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- von Lengerke T, Schock B, Hartlep I, Schipper P., Tomsic I, Krauth C, Chaberny IF. Promoting compliance with surgical site infection prevention guidelines by psychologically tailored interventions: study protocol of the multi-center parallel-group cluster-randomized controlled "WACH"-trial. [Abstract]. Antimicrob Resist Infect Control. 2019;8(1):30
- von Lengerke T, Tomsic I, Gossé F, Ebadi E, Hartlep I, Schipper P, Schock B, Chaberny IF. Planning is distinct from motivation and capabilities in explaining surgical site infection-preventive compliance: results from a single-centre, small sample but high response surgey of orthopaedic physicians in Hannover. [Abstract]. Antimicrob Resist Infect Control. 2019;8(1):69
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Tomsic I, Chaberny IF, Heinze NR, Krauth C, Schock B, von Lengerke T. The Role of Bundle Size for Preventing Surgical Site Infections after Colorectal Surgery: Is More Better? [Letter to the Editor]. J Gastrointest Surg. 2018;22(4):765-766
- Tomsic I, Heinze NR, Chaberny IF, Krauth C, Schock B, von Lengerke T. Implementation interventions in preventing surgical site infections in abdominal surgery: a systematic review. BMC Health Serv Res. 2020;20(1):236. doi: 10.1186/s12913-020-4995-z
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry