Trial | NCT02560155  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    1300
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.
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.
Study Started
Nov 30
2015
Primary Completion
Oct 31
2017
Study Completion
Feb 28
2018
Last Update
Feb 27
2018

Drug Mupirocin 2% nasal ointement

Mupirocin nasal ointement 2x/d for 5 days preoperatively

  • Other names: Bactroban Nasal

Drug Chlorhexidine sol 4%

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

  • Other names: Lifo-Scrub sol 4%

Nose-SA-carriers control No Intervention

Control Group, no intervention

Nose-SA-carriers decolonized Active Comparator

Chlorhexidine sol 4%; Mupirocin 2% nasal ointement 1 shower/day for 5 days and Nasal ointement 2x/d in each nostril for 5 days preoperatively

Non-nose-SA-carriers control No Intervention

Control Group, no intervention

Non-nose-carriers decolonized Active Comparator

Chlorhexidine sol 4% shower, daily for 5 days preoperatively

Criteria 

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
No Results Posted