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

Sponsor

Lindenhofgruppe AG (Industry)

Overall Status

Completed

CT.gov ID

NCT02560155

Collaborator

Clinical Trials Unit Bern (CTU) (Other), Lindenhofstiftung (Other), Labormedizinisches Zentrum Dr. Risch (Industry)

1,300

Enrollment

Location

Arms

Actual Duration (Months)

48.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Orthopedic Disorders Surgical Site Infection	Drug: Mupirocin 2% nasal ointement Drug: Chlorhexidine sol 4%	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

Oct 1, 2017

Actual Study Completion Date :

Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Nose-SA-carriers control Control Group, no intervention
Active Comparator: Nose-SA-carriers decolonized 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	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%
No Intervention: Non-nose-SA-carriers control Control Group, no intervention
Active Comparator: Non-nose-carriers decolonized Chlorhexidine sol 4% shower, daily for 5 days preoperatively	Drug: Chlorhexidine sol 4% Shower with Chlorhexidine sol 4% once a day for 5 days preoperatively Other Names: Lifo-Scrub sol 4%