Clinical Trials Logo

Clinical Trial Summary

Surgical site infections in orthopaedic surgery are a major problem. Decolonization has been suggested to reduce infection rates. The study was designed as a prospective, controlled, randomized, single-blinded trial to assess the influence of a decolonization procedure in S. aureus and non - S. aureus carriers. In this trial the 2 - year outcome in the subpopulation of prosthetic elective orthopaedic surgery will be evaluated.


Clinical Trial Description

To verify the main hypothesis, a prospective controlled randomized interventional trial with 2 parallel groups of patients of the Sonnenhof hospital undergoing an elective knee- or hip implant surgery was designed. A superiority framework for the decolonization procedure was used. All patients planned for such a procedure will be recruited during preoperative consultation by the orthopedic surgeons or by post and phone. Written informed consent will be obtained at this occasion. Study participants were screened 2-4 weeks prior intervention for nasal S. aureus colonization.

Study participants were allocated on a 1:1 basis either to an intervention or to a control group, but prosthesis implantation was not defined as randomization criteria in the initial trial. Randomization was stratified for important risk factors of SSI; procedure type (upper extremities and pelvic/hip, spine, knee and foot) and ASA-criteria (I, II, III -V). Stratification-groups were chosen in function of SSI's rate and expected number of operations/year. Randomization list were generated by the CTU and allocation was concealed using central randomization that was implemented in the REDCap data entry system.

One week prior to hospitalization patients in the intervention group received a decolonization kit by mail with instructions to apply mupirocin ointment 2% (BACTROBAN Nasal ong 3g, GSK) in each nostril 30mg (which corresponds approximately the same amount as the volume of a pea) twice a day and to shower daily (starting with the face, then from top to bottom the whole body emphasizing especially on nose, axillaries and pelvic region and then rinse. In a second time starting with the hair and then repeat the whole body. Dry with a proper towel (one for the 5 days)) with 25ml chlorhexidine gluconate soap, (Lifo-Scrub sol 4 % 500ml, B. Braun) during 5 days prior surgery. For non S. aureus carriers only skin cleansing without intranasal mupirocin application was used. This dosing schedule, mode of administration and treatment periods correspond to the allowed and recommended standards of Swissmedic and were not modified in this trial. Decolonization occured before hospitalization, as a fully completed course before surgery has been more effective. In some of the previous trials decolonization took place only at the beginning of hospitalization. The decolonization procedure was only completed after surgery had taken place and this possibly affected the results.

For practical reasons the use of a placebo kit within the control group abandoned. Operators, who are also the outcome assessors, will be blinded for either the carrier status or the decolonization procedure. Study participants will be told not to inform surgeons about performed decolonization procedure.

The incidence of PJI at two years in the intervention and control group will be assessed by phone interview. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03962907
Study type Interventional
Source Lindenhofgruppe AG
Contact
Status Completed
Phase Phase 4
Start date January 1, 2019
Completion date June 30, 2020

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04096885 - The Inselspital Surgical Cohort Study
Terminated NCT03820648 - Wound Protector Dual-ring Alexis® in Pancreaticoduodenectomy N/A
Completed NCT04067843 - Effect of Photodynamic Treatment on Skin Microbiome. Single Center Study N/A
Terminated NCT04042077 - Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections Phase 3
Completed NCT05841576 - Anaesthetic Management Guided by COMET Measurements N/A
Withdrawn NCT05338281 - NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT N/A
Recruiting NCT03042091 - Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery Early Phase 1
Completed NCT01697748 - Prospective Study on Cesarean Wound Outcomes N/A
Terminated NCT01789697 - Text Message Study N/A
Recruiting NCT05966961 - Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Recruiting NCT05077592 - Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections Phase 4
Recruiting NCT05763602 - PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study) Phase 4
Recruiting NCT05502380 - Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery Phase 3
Recruiting NCT03221023 - Intrawound Vancomycin Prophylaxis for Neural Stimulator Phase 2/Phase 3
Completed NCT03257202 - Topical Treatment and Prevalence of P. Acnes Phase 2
Completed NCT06154720 - Surgical Site Infection After Episiotomy Repair Related to Routine Use of Antibiotic Prophylaxis in Low-Risk Population
Not yet recruiting NCT06465901 - A Stratified, Multi-ARm, muLti-site Randomised Platform Trial Aiming to Reduce the INcidence of Post-operative SSI N/A
Not yet recruiting NCT04820075 - Efficacy of an Intervention to Improve the Preoperative Shower in Scheduled Surgery N/A
Recruiting NCT03561376 - Zinc Oxide Versus Petrolatum Following Skin Surgery Early Phase 1
Not yet recruiting NCT04496180 - Prevena to Prevent Surgical Site Infection After Emergency Abdominal Laparotomy N/A