Local Gentamicin Application to Reduce Postoperative Infection Rate

Tracking Information
First Submitted Date ICMJE	January 25, 2011
First Posted Date ICMJE	February 1, 2011
Last Update Posted Date	August 16, 2013
Study Start Date ICMJE	January 2011
Actual Primary Completion Date	July 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: January 31, 2011)	Number of patients with postoperatively infection after hemiarthroplasty to evaluate locally administered collagen-gentamicin peroperatively [ Time Frame: Within 4 weeks after prosthetic surgery ]; A randomized multicentre trial
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01287780 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Local Gentamicin Application to Reduce Postoperative Infection Rate
Official Title ICMJE	Local Gentamicin Application to Reduce Postoperative Infection Rate in Hemiarthroplasty After Fracture of the Proximal Femur: a Randomized Controlled Trial
Brief Summary	The majority of elderly patients with a displaced fracture of the proximal femur are now treated with a hemiarthroplasty. Prosthetic joint infection is a devastating complication, and the infection rate is high in this group of elderly patients. Local application of gentamicin produces high antibiotic concentrations in the wound. The aim of this study is to determine whether locally administered collagen-gentamicin in the joint perioperatively in addition to routine IV prophylaxis with beta-lactam antibiotics can reduce the early postoperative infection rate (< 4 weeks postoperative)after hemiarthroplasty in proximal femoral fractures.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Outcomes Assessor); Primary Purpose: Prevention
Condition ICMJE	Surgical Wound Infection
Intervention ICMJE	Device: Collagen-gentamicin sponge; A 10 by 10 cm sponge consisting of 280 mg collagen and 130 mg gentamicin.Two sponges are inserted during hemiarthroplasty surgery, one in the joint and one underneath the fascia at the time of surgical closure.; Other Names: Gentamicin-collagen sponge; Infection prophylaxis in orthopaedic surgery
Study Arms	Active Comparator: Collagen-gentamicin sponges Two sponges of collagen-gentamicin will be inserted into the hip immediately before closure of the wound. Each sponge (10 by 10 cm) contains 280 mg of collagen and 130 mg of gentamicin. Intervention: Device: Collagen-gentamicin sponge; No Intervention: No intervention
Publications *	Westberg M, Frihagen F, Brun OC, Figved W, Grøgaard B, Valland H, Wangen H, Snorrason F. Effectiveness of gentamicin-containing collagen sponges for prevention of surgical site infection after hip arthroplasty: a multicenter randomized trial. Clin Infect Dis. 2015 Jun 15;60(12):1752-9. doi: 10.1093/cid/civ162. Epub 2015 Mar 3.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: January 31, 2011)	800
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	August 2013
Actual Primary Completion Date	July 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Clinical diagnosis of proximal femoral fracture; Must be planned operated with a prosthesis of the hip Exclusion Criteria: Known allergy to gentamicin; Ongoing treatment with aminoglycosides; Reduced renal function; Pregnancy
Sex/Gender	Sexes Eligible for Study: All
Ages	Child, Adult, Older Adult
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Norway
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01287780
Other Study ID Numbers ICMJE	2010/18054
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Oslo University Hospital
Study Sponsor ICMJE	Oslo University Hospital
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Finnur Snorrason, Ph.D
PRS Account	Oslo University Hospital
Verification Date	August 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP