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

Lindenhof Group

Status: Completed

Conditions: Surgical Site Infection; Orthopedic Disorders

Treatments: Drug: Chlorhexidine sol 4%; Drug: Mupirocin 2% nasal ointement

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02560155

14-11-F

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,300 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,300 participants in 4 patient groups

Nose-SA-carriers control

No Intervention group

Description:

Control Group, no intervention

Nose-SA-carriers decolonized

Active Comparator group

Description:

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

Treatment:

Drug: Chlorhexidine sol 4%

Drug: Mupirocin 2% nasal ointement

Non-nose-SA-carriers control

No Intervention group

Description:

Control Group, no intervention

Non-nose-carriers decolonized

Active Comparator group

Description:

Chlorhexidine sol 4% shower, daily for 5 days preoperatively

Treatment:

Drug: Chlorhexidine sol 4%