Skip to main content
OpenTrials
Completed

NCT Number: NCT02560155

Preoperative Decolonization and Surgical Site Infections - a Prospective Randomized Trial

Surgical site infections are a major postoperative complication and are mostly due to colonization with endogenous germs, like Staphylococcus aureus, Staphylococcus epidermidis or Propionibacterium acnes. In literature, preoperative decolonization procedures showed a trend in lowering surgical site infection rates, but especially in orthopedic surgery data is controversial and randomized controlled trials are lacking. In the main study, the study investigators aim at performing a controlled prospective randomized interventional trial to measure the impact of preoperative decolonization of nasal Staphylococcus aureus carriers on surgical site infection rates in orthopedic surgery. In an alongside study a controlled prospective randomized interventional trial to measure the impact of preoperative skin decolonization of patients undergoing an orthopedic procedure will be conducted.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Orthopedic Disorders Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Staphylococcal Infections Surgical Site Infection Surgical Wound Infection Wound Infection

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sonnenhofspital, Lindenhofgruppe

Bern, 3006, Switzerland

About this study

All participants will be assessed for eligibility during preoperative othopedic consultation. 2-3 weeks prior operation date participants will be screened for Staph. aureus carriage by nose-swab. According to nose-swab results randomizaton and allocation to study arm will be performed.

After one and three months post-operatively participants will be asked by phone interview if surgical site infections occured. Results have to be confirmed by orthopedic surgeon if possible.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patient older than 16 years
  • patient undergoing elective orthopedic procedure at the Sonnenhof hospital
  • decolozination protocol can be performed timely
  • signed informed consent

Exclusion criteria

  • no orthopedic surgery planned
  • allergy to mupirocin or chlorhexidine
  • presence of a nasal foreign body
  • no informed consent
  • pregnancy
  • decolozination protocol can't be followed timely
  • patients undergoing treatment/surgery for a documented infection

Treatment and study plan

Mupirocin 2% nasal ointement

Drug

Mupirocin nasal ointement 2x/d for 5 days preoperatively

Other names: Bactroban Nasal

Chlorhexidine sol 4%

Drug

Shower with Chlorhexidine sol 4% once a day for 5 days preoperatively

Other names: Lifo-Scrub sol 4%

Primary outcomes

  1. Overall number of participants with surgical site infections 3 months postoperatively

    Time frame: 3 months

    Phone interview and orthopedic assessement

Secondary outcomes

  1. Number of participants with surgical site infections at 1 and 3 months postoperatively

    Time frame: 1 and 3 months

    Phone interview and orthopedic assessement

Other outcomes

  1. Total screening costs

    Time frame: one year

    Total screening costs divided by the number of prevented SSI to assess cost-effectiveness

Sponsors and collaborators

Lead sponsor

Lindenhofgruppe AG

Industry

Collaborators

  • Clinical Trials Unit Bern (CTU)
  • Labormedizinisches Zentrum Dr. Risch
  • Lindenhofstiftung

Registry information

Official study title

Preoperative Decolonization and Surgical Site Infections - a Prospective Randomized Trial (DECO-SSI Trial)

Acronym: DECO-SSI

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Sep 25, 2015
Registry last updated
Feb 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.