Sprowson, Andrew P., Jensen, Cyrus D., Gupta, Sanjay (Researcher in medicine), Parsons, Nicholas R., Murty, Aradhyula N., Jones, Simon M. G., Inman, Dominic and Reed, Mike R. (2013) The effect of high dose antibiotic impregnated cement on rate of surgical site infection after hip hemiarthroplasty for fractured neck of femur : a protocol for a double-blind quasi randomised controlled trial. BMC Musculoskeletal Disorders, Volume 14 (Number 1). Article number 356. doi:10.1186/1471-2474-14-356

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Abstract

Background:
Mortality following hip hemiarthroplasty is in the range of 10-40% in the first year, with much attributed to post-operative complications. One such complication is surgical site infection (SSI), which at the start of this trial affected 4.68% of patients in the UK having this operation. Compared to SSI rates of elective hip surgery, at less than 1%, this figure is elevated. The aim of this quasi randomised controlled trial (RCT) is to determine if high dose antibiotic impregnated cement can reduce the SSI in patients at 12-months after hemiarthroplasty for intracapsular fractured neck of femur.

Methods:
848 patients with an intracapsular fractured neck of femur requiring a hip hemiarthroplasty are been recruited into this two-centre double-blind quasi RCT. Participants were recruited before surgery and quasi randomised to standard care or intervention group. Participants, statistician and outcome assessors were blind to treatment allocation throughout the study. The intervention consisted of high dose antibiotic impregnated cement consisting of 1 gram Clindamycin and 1 gram of Gentamicin. The primary outcome is Health Protection Agency (HPA) defined deep surgical site infection at 12 months. Secondary outcomes include HPA defined superficial surgical site infection at 30 days, 30 and 90-day mortality, length of hospital stay, critical care stay, and complications.

Discussion:
Large randomised controlled trials assessing the effectiveness of a surgical intervention are uncommon, particularly in the speciality of orthopaedics. The results from this trial will inform evidence-based recommendations for antibiotic impregnated cement in the management of patients with a fractured neck of femur undergoing a hip hemiarthroplasty. If high dose antibiotic impregnated cement is found to be an effective intervention, implementation into clinical practice could improve long-term outcomes for patients undergoing hip hemiarthroplasty.

Item Type:	Journal Article
Subjects:	R Medicine > RD Surgery
Divisions:	Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Hip joint -- Surgery -- Complications -- Prevention, Femur neck -- Surgery -- Complications -- Prevention, Surgical wound infections -- Prevention -- Research, Bone cements, Clinical trials
Journal or Publication Title:	BMC Musculoskeletal Disorders
Publisher:	Biomed central
ISSN:	1471-2474
Official Date:	2013
Dates:	Date Event 2013 UNSPECIFIED
Date of first compliant deposit:	26 December 2015
Volume:	Volume 14
Number:	Number 1
Page Range:	Article number 356
DOI:	10.1186/1471-2474-14-356
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access
Funder:	Heraeus Medical GmbH (UK)

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