NCT02428179

Brief Summary

Surgical site infection (SSI) is the most frequent complication in patients that undergo abdominal surgery. A previous prospective observational study in 167 patients undergoing elective open abdominal procedures showed that case-relevant communication protects from organ/space SSI whereas case-irrelevant communication during the last 20 minutes of the procedure is a risk factor for incisional SSI. Therefore, the introduction of a clinical applicable intervention "structured briefing using the StOP protocol" has been developed and was tested in pilot experiments. This intervention aims at improving case-relevant communication during the procedure and to reduce excess case-irrelevant communication at the end of an operation. The hypothesis is: structured briefings during an operation reduce the incidence of SSI after surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,003

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 28, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 15, 2017

Status Verified

March 1, 2017

Enrollment Period

1.7 years

First QC Date

April 23, 2015

Last Update Submit

March 14, 2017

Conditions

Incidence of Surgical Site InfectionShort Intraoperative BriefingsMortalityShared Mental Model

Keywords

Surgical site infectionIntraoperative briefingsMortalityWound closureSurgical procedure

Outcome Measures

Primary Outcomes (1)

  • Incidence of surgical Site infections

    30 days postoperative

Secondary Outcomes (3)

  • Postoperative mortality

    30 days postoperative

  • Type of Operation / Laparoscopic procedure

    30 days postoperative

  • Grade of contamination

    30 days postoperative

Study Arms (2)

Control group without Study intervention

Control group without Study intervention

Procedure: StOP? - Control group

Group with Study intervention

Group with Study intervention

Procedure: StOP? - Intervention group

Interventions

StOP? - Control groupPROCEDURE

Control group - Surgical procedure without Study Intervention

Control group without Study intervention
StOP? - Intervention groupPROCEDURE

Intervention group - Surgical procedure with intraoperative briefings, optional interventions: Transparent drape between anesthesia and sterile team, Controlling noise and potential distractors during wound closure, Nutritional support during the operation

Group with Study intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing abdominal surgery

You may qualify if:

  • Patients undergoing elective or emergency surgery

You may not qualify if:

  • Preexisting surgical site infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Inselspital

Bern, 3010, Switzerland

Location

Related Publications (5)

  • Sax H, Uckay I, Balmelli C, Bernasconi E, Boubaker K, Muhlemann K, Ruef C, Troillet N, Widmer A, Zanetti G, Pittet D. Overall burden of healthcare-associated infections among surgical patients. Results of a national study. Ann Surg. 2011 Feb;253(2):365-70. doi: 10.1097/SLA.0b013e318202fda9.

    PMID: 21217517RESULT

  • Weber WP, Zwahlen M, Reck S, Feder-Mengus C, Misteli H, Rosenthal R, Brandenberger D, Oertli D, Widmer AF, Marti WR. Economic burden of surgical site infections at a European university hospital. Infect Control Hosp Epidemiol. 2008 Jul;29(7):623-9. doi: 10.1086/589331.

    PMID: 18564917RESULT

  • Mazzocco K, Petitti DB, Fong KT, Bonacum D, Brookey J, Graham S, Lasky RE, Sexton JB, Thomas EJ. Surgical team behaviors and patient outcomes. Am J Surg. 2009 May;197(5):678-85. doi: 10.1016/j.amjsurg.2008.03.002. Epub 2008 Sep 11.

    PMID: 18789425RESULT

  • Nurok M, Sundt TM 3rd, Frankel A. Teamwork and communication in the operating room: relationship to discrete outcomes and research challenges. Anesthesiol Clin. 2011 Mar;29(1):1-11. doi: 10.1016/j.anclin.2010.11.012.

    PMID: 21295749RESULT

  • Catchpole K, Mishra A, Handa A, McCulloch P. Teamwork and error in the operating room: analysis of skills and roles. Ann Surg. 2008 Apr;247(4):699-706. doi: 10.1097/SLA.0b013e3181642ec8.

    PMID: 18362635RESULT

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Guido Beldi, Prof. Dr. med.

    Visceral and transplant surgery, University hospital, Berne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2015

First Posted

April 28, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

March 15, 2017

Record last verified: 2017-03

Locations

CH(1)