Literature DB >> 30023452

Does the Alexis wound retractor increase the risk of blood splashes to the eyes? Early closure of a double blinded randomised controlled trial.

Sally Ooi1, Douglas Stupart1,2, Hugh Gillies1, David Watters1,2.   

Abstract

Entities:  

Year:  2018        PMID: 30023452      PMCID: PMC6046451          DOI: 10.1016/j.conctc.2018.01.001

Source DB:  PubMed          Journal:  Contemp Clin Trials Commun        ISSN: 2451-8654


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Blood splashes to the eye during surgery create a risk to the surgeon and other theatre staff for the transmission of blood-borne infections, especially HIV and hepatitis B or C [1]. The Alexis wound retractor is commonly used during abdominal surgery. It is a double ring polyurethane retractor, consisting of two plastic rings joined by a flexible plastic sleeve. It provides effective retraction of the wound and protects the wound from infection [[2], [3], [4], [5], [6], [7], [8], [9]]. However, when the retractor is removed (by unrolling the outer ring of the retractor), there is a risk that blood droplets are sprayed into the air which may increase the risk of blood splashes to the surgeon or assistant's eyes. The purpose of this study was to determine whether the use of the Alexis retractor for abdominal surgery leads to an increased risk of blood splashes to the surgeon's or assistant's eyes. This was a double blinded randomised controlled trial on adult patients undergoing surgery requiring an intraperitoneal abdominal incision at the University Hospital, Geelong (a regional referral hospital in Victoria, Australia). The operations were randomly assigned to one group where the Alexis retractor was used, and the control group in which it was not. Operative technique in the two arms was similar. In both groups, the surgeon and assistant wore transparent visors. An investigator who was blinded to whether the Alexis retractor had been used counted the number of macroscopic blood spots on the visor (in keeping with previous methodology [10]). The study was designed to detect an increase in mean blood splashes from 2.5 to 5 per visor, with a standard deviation of 3.6 (from Ogendo et al. [11]). The required sample size was 44 operations in each arm. During the study period, the WHO published guidelines recommending routine use of the Alexis retractor for bowel surgery [12], so we decided that we could no longer ethically randomize patients into the control arm, and closed the trial prematurely. At this time, 25 operations had been included in the study (twelve in the Alexis group and 13 controls), so 50 visors were studied. A median of zero (range 0–5) blood splashes were detected in the Alexis group, and zero (range 0–9) in the controls (P = .91). This is the only study which has attempted to determine whether using the Alexis retractor poses any risk to the surgical team through blood splashes. Unfortunately the trial was underpowered to definitely answer that question. However, the number of blood splashes in the Alexis groups were low (median of zero blood splashes to the masks of surgeons or assistants), so it seems reasonable to conclude that the use of the Alexis retractor does not add any clinically significant risk. In summary, we could not detect any increased risk of blood splashes to the eyes of surgeons or their assistants from the use of the Alexis retractor, but the study was underpowered due to early trial closure.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
  11 in total

1.  Randomized, controlled investigation of the anti-infective properties of the Alexis retractor/protector of incision sites.

Authors:  Tetsuya Horiuchi; Hiroyuki Tanishima; Kouji Tamagawa; Ichiro Matsuura; Hiroaki Nakai; Yoshiharu Shouno; Hideaki Tsubakihara; Masaya Inoue; Katsuyoshi Tabuse
Journal:  J Trauma       Date:  2007-01

2.  Blood and body fluid splashes during surgery--the need for eye protection and masks.

Authors:  C G Davies; M N Khan; A S K Ghauri; C J Ranaboldo
Journal:  Ann R Coll Surg Engl       Date:  2007-11       Impact factor: 1.891

3.  Wound protectors reduce surgical site infection: a meta-analysis of randomized controlled trials.

Authors:  Janet P Edwards; Adelyn L Ho; May C Tee; Elijah Dixon; Chad G Ball
Journal:  Ann Surg       Date:  2012-07       Impact factor: 12.969

4.  Risk of conjunctival contamination from blood splashes during surgery at the Kenyatta National Hospital, Nairobi.

Authors:  S W O Ogendo; M N Awori; M A Omondi; E M Mulatya; P W Mugo
Journal:  East Afr Med J       Date:  2008-09

Review 5.  Wound edge protector for prevention of surgical site infection in laparotomy: an updated systematic review and meta-analysis.

Authors:  Ming-Xia Zhang; Yi-Hui Sun; Zheng Xu; Ping Zhou; Hong-Xia Wang; Yong-You Wu
Journal:  ANZ J Surg       Date:  2015-02-03       Impact factor: 1.872

6.  Barrier wound protection decreases surgical site infection in open elective colorectal surgery: a randomized clinical trial.

Authors:  Kate Reid; Peter Pockney; Brian Draganic; Stephen R Smith
Journal:  Dis Colon Rectum       Date:  2010-10       Impact factor: 4.585

7.  Impact of a surgical site infection reduction strategy after colorectal resection.

Authors:  T M Connolly; C Foppa; E Kazi; P I Denoya; R Bergamaschi
Journal:  Colorectal Dis       Date:  2016-09       Impact factor: 3.788

8.  ALEXIS O-Ring wound retractor vs conventional wound protection for the prevention of surgical site infections in colorectal resections(1).

Authors:  K P Cheng; A C Roslani; N Sehha; J H Kueh; C W Law; H Y Chong; K Arumugam
Journal:  Colorectal Dis       Date:  2012-06       Impact factor: 3.788

9.  Plastic wound retractors as bacteriological barriers in gastrointestinal surgery: a prospective multi-institutional trial.

Authors:  H M Mohan; S McDermott; L Fenelon; N M Fearon; P R O'Connell; S F Oon; J Burke; E Keane; C Shields; D C Winter
Journal:  J Hosp Infect       Date:  2012-05-11       Impact factor: 3.926

Review 10.  Systematic review of the clinical effectiveness of wound-edge protection devices in reducing surgical site infection in patients undergoing open abdominal surgery.

Authors:  Adrian Gheorghe; Melanie Calvert; Thomas D Pinkney; Benjamin R Fletcher; David C Bartlett; William J Hawkins; Tony Mak; Haney Youssef; Sue Wilson
Journal:  Ann Surg       Date:  2012-06       Impact factor: 12.969

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