CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3,003 enrolled
Drug / intervention
StOP? - Control group +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02428179
NCT02428179N/ACompleted

StOP?-Trial: Impact of Structured Communication in the OR on Surgical Site Infections: Prospective Observational Clinical Trial

Insel Gruppe AG, University Hospital Bern·observational·Posted Apr 28, 2015·Updated Mar 15, 2017

In Brief

An observational study evaluating StOP? - Control group and StOP? - Intervention group for Incidence of Surgical Site Infection and 3 related conditions. Completed, enrolled 3,003 participants across 1 site.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 28, 2015
Enrollment StartApr 1, 2015
Primary CompletionDec 1, 2016
Study CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 11.2 years ago

Interventions

StOP? - Control groupprocedure

Control group - Surgical procedure 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