Intraoperative Microbial Contamination

NCT03139539 | Completed DMC

• 1 other identifier: H-15012754
• Study Type: interventional
• Target: 1,661
• Locations: 1 country
• Sites: 3

Brief Summary

This is a randomized, controlled study which aims to show whether iodine impregnated incisional foil (IobanTM) has a place in the prevention of prosthetic joint infection (PJI). 1200 patients will be included in this study and will be followed through out a ten year period. Follow up will center on the function of the prosthetic knee, early and late infection rates and revision surgery due to aseptic loosening. Our purpose is to gain insight in to the causes of post-operative infection in joint alloplasty surgery. Our hypothesis' are:

1. 1.The patient's skin flora is the main source of intraoperative contamination,
2. 2.Intraoperative contamination can be reduced by using IobanTM
3. 3.Intraoperative contamination strongly predicts postoperative infection
4. 4.Unsuccessful clinical outcomes of knee arthroplasty are caused by low-grade infections.
5. 5.Intraoperative contamination
6. 6.Postoperative infection

Conditions

Periprosthetic Joint Infection

Outcome Measures

Primary Outcomes (2)

• Does Ioban prevent intraoperative microbial contamination?

  A randomized controlled study is performed to determine the effect of iodine impregnated incisional drape on intraoperative contamination. The primary outcome is the frequency of intraoperative contamination in the projects' two arms.

  approximately 2 hours. Sampling is done during surgery.

• Sources of intraoperative contamination

  A prospective study is performed to assess the frequency of intraoperative contamination. During standard knee arthroplasty surgeries the samples are obtained. Three swabs, (Copan ESwab) will be taken during surgery. The first swab is taken from the skin of the surgical site prior to skin preparation. The second swab just after incision and will be of the wound edges. Intra-operative contaminants are cultured from the glove of the surgeon's dominant hand using a special glove culture technique with samples taken 30 minutes after skin incision (or before changing gloves when handling implants or using bone cement impregnated with antibiotics - whichever comes first) and the third swab is taken from the skin edges after closure of the subcutaneous tissue before closure of the skin. All the samples will be cultured and undergo susceptability testing. Analysis will determine the most frequent source of contamination.

  approximately 2 hours. Sampling is done during surgery.

Secondary Outcomes (1)

• Postoperative infections are caused (are not caused) by intra-operative contamination.

  Approximately 4 hours. Sampling done during revision surgery

Study Arms (2)

Ioban

ACTIVE COMPARATOR

In this arm patients will be operated using Ioban as incisional drape.

Device: Ioban

Control

NO INTERVENTION

In this arm patients will be operated using no incisional drape.

Interventions

Ioban DEVICE

Also known as: iodine impregnated incisional foil

Ioban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• known allergy or hypersensitivity to iodine or adhesive drape
• history of infection in the knee (e.g. septic arthritis, osteomyelitis)
• active infection at another site at the time of surgery
• antibiotic use within 4 weeks before surgery
• previous enrolment in the study.

Sponsors & Collaborators

• University of Copenhagen: lead
• Frederiksberg University Hospital: collaborator
• Hillerod Hospital, Denmark: collaborator
• Aarhus University Hospital: collaborator

Study Sites (3)

Aarhus Universitetshospital

Aarhus, 8000, Denmark

Location

Herlev and Gentofte Hospital

Gentofte Municipality, 2900, Denmark

Location

Nordsjællands Hospital

Hillerød, 3400, Denmark

Location

Related Publications (12)

• Jamsen E, Varonen M, Huhtala H, Lehto MU, Lumio J, Konttinen YT, Moilanen T. Incidence of prosthetic joint infections after primary knee arthroplasty. J Arthroplasty. 2010 Jan;25(1):87-92. doi: 10.1016/j.arth.2008.10.013. Epub 2008 Dec 4.

  PMID: 19056210 BACKGROUND

• Phillips JE, Crane TP, Noy M, Elliott TS, Grimer RJ. The incidence of deep prosthetic infections in a specialist orthopaedic hospital: a 15-year prospective survey. J Bone Joint Surg Br. 2006 Jul;88(7):943-8. doi: 10.1302/0301-620X.88B7.17150.

  PMID: 16799001 BACKGROUND

• Whitehouse JD, Friedman ND, Kirkland KB, Richardson WJ, Sexton DJ. The impact of surgical-site infections following orthopedic surgery at a community hospital and a university hospital: adverse quality of life, excess length of stay, and extra cost. Infect Control Hosp Epidemiol. 2002 Apr;23(4):183-9. doi: 10.1086/502033.

  PMID: 12002232 BACKGROUND

• Culliford D, Maskell J, Judge A, Cooper C, Prieto-Alhambra D, Arden NK; COASt Study Group. Future projections of total hip and knee arthroplasty in the UK: results from the UK Clinical Practice Research Datalink. Osteoarthritis Cartilage. 2015 Apr;23(4):594-600. doi: 10.1016/j.joca.2014.12.022. Epub 2015 Jan 9.

  PMID: 25579802 BACKGROUND

• Gallo J, Kolar M, Novotny R, Rihakova P, Ticha V. Pathogenesis of prosthesis-related infection. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2003 Nov;147(1):27-35. doi: 10.5507/bp.2003.004.

  PMID: 15034602 BACKGROUND

• Arnold WV, Shirtliff ME, Stoodley P. Bacterial biofilms and periprosthetic infections. J Bone Joint Surg Am. 2013 Dec 18;95(24):2223-9. doi: 10.2106/JBJS.2223. No abstract available.

  PMID: 24498639 BACKGROUND

• Trampuz A, Zimmerli W. Prosthetic joint infections: update in diagnosis and treatment. Swiss Med Wkly. 2005 Apr 30;135(17-18):243-51. doi: 10.4414/smw.2005.10934.

  PMID: 15965826 BACKGROUND

• Nelson CL, McLaren AC, McLaren SG, Johnson JW, Smeltzer MS. Is aseptic loosening truly aseptic? Clin Orthop Relat Res. 2005 Aug;(437):25-30. doi: 10.1097/01.blo.0000175715.68624.3d.

  PMID: 16056022 BACKGROUND

• Lange-Asschenfeldt B, Marenbach D, Lang C, Patzelt A, Ulrich M, Maltusch A, Terhorst D, Stockfleth E, Sterry W, Lademann J. Distribution of bacteria in the epidermal layers and hair follicles of the human skin. Skin Pharmacol Physiol. 2011;24(6):305-11. doi: 10.1159/000328728. Epub 2011 Jul 15.

  PMID: 21757977 BACKGROUND

• Al-Qahtani SM, Al-Amoudi HM, Al-Jehani S, Ashour AS, Abd-Hammad MR, Tawfik OR, Baslaim MM, Farrokhyar F. Post-appendectomy surgical site infection rate after using an antimicrobial film incise drape: a prospective study. Surg Infect (Larchmt). 2015 Apr;16(2):155-8. doi: 10.1089/sur.2013.188. Epub 2014 Aug 15.

  PMID: 25126720 BACKGROUND

• Haliasos N, Bhatia R, Hartley J, Thompson D. Ioban drapes against shunt infections? Childs Nerv Syst. 2012 Apr;28(4):509-10. doi: 10.1007/s00381-012-1724-x. Epub 2012 Feb 22. No abstract available.

  PMID: 22354120 BACKGROUND

• Segal CG, Anderson JJ. Preoperative skin preparation of cardiac patients. AORN J. 2002 Nov;76(5):821-8. doi: 10.1016/s0001-2092(06)61035-1.

  PMID: 12463081 BACKGROUND

Related Links

• The Danish Knee Registry
• Diagnosis and procedure codes

Study Officials

• Thomas Bjarnsholt

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Primary Investigator

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 4, 2017
• Study Start: March 1, 2016
• Primary Completion: April 30, 2018
• Study Completion: October 1, 2018
• Last Updated: October 15, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share

Locations

DK (3)