Across the world it is estimated that over a billion peripheral intravenous cannulas (PIVCs) are placed annually, more than 300 million of which are placed in the US (Zingg and Pittet, 2009, PR Newswire). In addition, in 2005 it was estimated that five million and 200 000 central venous catheters (CVCs) were used in the US and UK, respectively each year (Worthington, 2005).
Health professionals must constantly strive to minimise the complications associated with these devices. Complications can include: infection, both systemic and local; vessel trauma and/or thrombosis; skin damage; and catheter migration.
Complications affect the wellbeing of patients, and catheter failure necessitates device replacement. Replacing a vascular access device (VAD) can cause disruption to intravenous (IV) therapy, inconvenience to patients, increased healthcare-associated costs and is at odds with the principles of vessel health and preservation (Hallam et al, 2016).
Complications: PIVCs
There are several complications associated with PIVCs, including:
Complications: central venous access devices
Complications associated with central venous access devices (CVADs) include:
Development of tissue adhesive
Cyanoacrylate (CA) adhesive has been in use for many years and is commonly known as superglue. Introduced into the industrial market in 1958, it was not widely available commercially until the 1970s, when it was marketed as an instant adhesive that bonded immediately with a variety of materials (Klemarczyk and Guthrie, 2010).
In 1998, it was first approved for medical use (Singer et al, 2004). Since then, it has been developed for use in medical practice as an alternative to sutures for minor wounds (Prince et al, 2018) and, more recently, has been demonstrated as being suitable for use with VADs (Simonova et al, 2012).
Properties of CA tissue adhesive
The development of CA tissue adhesive has brought improvements to some of its inherent properties and an increase in antimicrobial activity. A comparison of the properties of older and newer generation products is shown in Table 1.
| First generation | Second generation |
|---|---|
| Butyl-cyanoacrylate (BCA) | 2-octyl-cyanoacrylate (OCA) |
| Quick drying | Longer drying time |
| Rigid/brittle | Higher tensile strength and more flexible |
| More cytotoxic | Less cytotoxic |
| Stronger thermal reaction | Reduced thermal reaction |
| Requires minimum 24 hours before fully water resistant | Immediately water resistant |
Source: Internal testing by Adhezion Biomedical
Early generation CA tissue adhesive was found to have an inhibitory effect against Gram-positive bacteria, but not against Gram-negative bacteria or Candida albicans (Wilkinson et al, 2008; Prince et al, 2018)
Some second-generation products (2-octyl and octyl blends), however, have demonstrated broad spectrum activity against Gram-positive and Gram-negative bacteria, yeast and fungi (Prince et al, 2017).
Tissue adhesive in the prevention of VAD complications
Tissue adhesive helps to prevent VAD complications for four reasons:
Clinical outcomes
There is some evidence supporting the use of CA tissue adhesive with PIVCs, peripheral arterial catheters, CVADs and epidural catheters. There is a comprehensive summary in an article entitled ‘Tissue adhesive for vascular access devices: who, what, where and when?’ (Corley et al, 2017).
It is worth, however, looking at some of the evidence that is pertinent to vascular access in more detail. The studies described below show a variety of approaches and sample sizes with various outcome measures.
Tissue adhesive: PIVCs
Positive results have been shown in some randomised controlled trials (RCTs) that looked at the role of tissue adhesive on PIVC failure rate.
Marsh et al (2015) (Table 2) performed a small, four-arm RCT in adults on medical surgical units looking at catheter failure and premature removal because of complications. While there was a lower rate of failure in the tissue adhesive group, there were some adverse events related to the product being an early n-butyl product.
| Standard polyurethane control group | Bordered polyurethane | Sutureless securement and standard polyurethane | Tissue adhesive and standard polyurethane | |
|---|---|---|---|---|
| Number | 21 | 20 | 23 | 21 |
| Number failed | 8 | 5 | 5 | 3 |
| Failure rate per 1000 catheter hours | 6.92 | 3.82 | 3.14 | 2.40 |
| Adverse events | 0 | 0 | 0 | 4 |
Bugden et al (2016) (Table 3) performed a larger scale, twoarm RCT in adult emergency patients who had either bordered polyurethane and tape or bordered polyurethane and tape and tissue adhesive applied; failure and modes of failure were assessed at 48 hours.
| Bordered polyurethane and tape | Tissue adhersive, bordered polyurethane and tape | |
|---|---|---|
| Number | 190 | 179 |
| Failure No (%) | 52 (27%) | 31 (17%) |
| Dislodgement | 26 (14%) | 13 (7%) |
| Phlebitis | 9 (5%) | 6 (3%) |
| Occlusion | 20 (11%) | 15 (8%) |
A larger scale RCT published in the Lancet (Rickard et al, 2018) showed a failure rate of tissue adhesive used with standard polyurethane of 12.7 per 100 PIVC days in comparison to 18.3, 19.6 and 15.9 in other groups. The trial took place in two facilities over an 18-month period between March 2013 and September 2014 (Table 4).
| Standard polyurethane control group | Bordered polyurethane | Sutureless securement and standard polyurethane | Tissue adhersive and standard polyurethane | |
|---|---|---|---|---|
| Number | 454 | 454 | 453 | 446 |
| % failure: total | 43% | 40% | 41% | 38% |
| % failure: pre-protocol analysis | 34% | 35% | 34% | 26% |
| Failure rate per 100 PIVC days | 18.3 | 19.6 | 15.9 | 12.7 |
| % occlusion | 22% | 19% | 23% | 16% |
| Dislodgement per 100 PIVC days | 3.5 | 3.5 | 3.0 | 2.4 |
Tissue adhesive: CVADs in adults
A study of 221 acute CVCs (Rickard et al, 2016) showed a superior dwell time for those secured with both tissue adhesive and sutures covered with a standard polyurethane dressing (Table 5). The trial initially looked at the use of tissue adhesive and dressing alone but this had to be abandoned because of high failure rates; it is considered that glue alone in complex vascular access and more dependent patients does not provide enough securement.
| Suture and bordered polyurethane | Suture and lattice pad dressing | Sutureless securement and standard polyurethane | Tissue adhesive and standard polyurethane | Tissue adhesive, suture and standard polyurethane | |
|---|---|---|---|---|---|
| Number | 55 | 56 | 55 | 23 | 30 |
| Catheter failure: n (%) | 2 (4) | 1 (2) | 4 (7) | 4 (17) | 0 (0) |
| Median dwell time (hours) | 69 | 68.2 | 67.8 | 69 | 72.2 |
This study was a four-arm randomised trial of elective cardiac surgical patients with a fifth arm added. The catheters were either 8.5 Fr 20 cm quadruple lumen or 7 Fr 16 cm triple lumen. All were chlorhexidine impregnated and inserted into the internal jugular vein.
Tissue adhesive: CVADs in children
A study on PICC failure rate in 65 paediatric patients (Kleidon et al, 2017) showed a reduction of 3% in those who received tissue adhesive with a bordered polyurethane dressing compared to either a bordered polyurethane dressing with a sutureless securement device or an integrated securement dressing (Table 6). There was, however, a higher incidence of skin issues with the tissue adhesive group. It should be noted that, as with the study shown in Table 2, this was using the first-generation n-butyl formula. Other complications such as bleeding, lifting of the dressing and leakage occurred less in the group randomised to receive the tissue adhesive. The number of days to the first dressing change was also greater in the tissue adhesive group.
| Bordered polyurethane and sutureless securement (n=32) | Integrated securement device (n=31) | Tissue adhesive and bordered polyurethane n=32 | |
|---|---|---|---|
| PICC failure | 2 (6%) | 2 (6%) | 1 (3%) |
| Incident rate/1000 catheter days | 8 | 8 | 3 |
| Dwell time | 8 | 7 | 7 |
| Adverse skin events* | 5 (16%) | 3 (10%) | 10 (31%) |
| Parental satisfaction (0–10) | 7.6 | 9.7 | 8.5 |
*Itchiness, rash, skin tear, blister or bruising at any time during study
This study was a three-arm, single-centre pilot RCT that had PICC failure as a primary outcome measure.
Another study (Table 7) looking at a smaller number (n=48) of tunnelled CVADs showed a reduction in routine dressing changes and no adverse skin reactions in comparison to a 17%, 8% and 18% occurrence of skin reactions with the other categories of securement (Ullman et al, 2017). Of note (but not included in the table) there was high staff approval on application, but not on removal, whereas parental satisfaction was high on removal.
| Integrated securement device and suture n=12 | Sutureless securement + suture + bordered polyurethane n=13 | Bordered polyurethane +suture (control) n=11 | Tissue adhesive and bordered polyurethane n=12 | |
|---|---|---|---|---|
| CVAD failure | 2 (17%) | 1 (8%) | 0 | 0 |
| Complications | 1 (8%) | 2 (15%) | 0 | 0 |
| Adverse skin event* | 2 (17%) | 1 (8%) | 2 (18%) | 0 |
| Non-routine CVAD dressing | 10 | 25 | 17 | 4 |
*Itchiness, rash, skin tear, blister or bruising at any time during study
Case study: reducing infection, bleeding and thrombosis risk
A retrospective case study of an enhanced CVAD CRBSI prevention bundle was carried out between June 2009 and June 2014. The enhanced prevention bundle incorporated ultrasound pre-puncture evaluation, tunnelled exit site, tissue adhesive at the catheter exit site, consistent use of transparent dressings and a simulation-based training programme for all inserters. During this period, the CRBSI rate for all centrally inserted central catheters dropped from 15 per 1000 catheter-days to 1.5 per 1000 catheter-days, with a 2.2 day longer dwell time. The authors concluded that sealing the exit site reduced the risk of extraluminal contamination, bleeding at the puncture site and the ‘pistoning’ motion of the catheter, which reduced damage to the endothelium and therefore thrombosis risk (Biasucci et al, 2017).
Cost and time savings
There is clearly potential to save both time and costs when using tissue adhesive in the management of VADs. The potential for reduction in CRBSI also has implications for cost and time saving as well as improving the patient experience and outcome.
Elimination of the 24-hour dressing: a quick win
The optimal CVAD dressing is a transparent film dressing (National Institute for Health and Care Excellence, 2012; Loveday et al, 2014) which allows the intravascular site to be inspected. It is, however, common practice to apply gauze over the insertion site initially to absorb any post-insertion bleeding. A 24-hour, post-insertion dressing would then be applied (Royal College of Nursing, 2016). By using tissue adhesive, it is possible to eliminate the need for this 24-hour, post-insertion dressing as haemostasis can be achieved before the transparent film dressing is applied.
A poster presented at the Association of Vascular Access 2016 annual scientific meeting outlined a review of 1429 CVADs that showed 100% success in preventing post-insertion bleeding and a tenfold reduction in CRBSI (Pittiruti, 2016). A smaller study presented in 2018 showed a 57% reduction in premature dressing changes associated with the use of tissue adhesive (Judge et al, 2018).
This has cost and time benefits for patients and healthcare facilities alike. For example, if 1000 CVADs were placed in a hospital over one year, using tissue adhesive would save 250 nurse/healthcare worker hours (assuming that a dressing change takes 15 minutes). Outpatients who have to travel to have a dressing changed will save the cost and time of a journey and disruption to their day. Community nurses who have, for example, a caseload of 10 patients with PICCs or midlines will save on 10 initial patient visits.
Case study: tissue adhesive post-PICC insertion
The PICC insertion procedure requires the use of large cannulas for vessel access under ultrasound, dilation of tissue at the site and finally, PICC insertion. It is expected that there is some slight bleeding/oozing right at the site after the catheter is inserted. The dressing used for the first 24 hours is opaque and typically a gauze-type adhesive dressing that requires removal and change after 24 hours. The impact of this protocol is that a procedure is required that entails dressing supplies, nursing time and for the patient, inconvenience for an additional procedure and potential for skin impairment and discomfort. This case study will discuss the clinical situation of a patient who had a PICC insertion during the evaluation of an intervention to eliminate the bleeding/oozing at the catheter site and to eliminate the clinical need for a dressing change after the first 24 hours post-insertion.
RC is a 22 year old male patient with cystic fibrosis (CF) who was seen in the CF clinic to start on home IV antibiotics through a PICC. RC has had numerous PICC insertions in the past due to his chronic condition and exacerbations with respiratory infections. This patient is well-known to the CF and Home IV Programs and is independent with his IV infusions and care, except for his PICC dressings. Due to the location of the PICC in the inner aspect of the upper arm, it is very difficult to do as self-care. A home care nurse visit or trip to the community health unit is required for the PICC dressing change procedure. RC was very willing to participate in our evaluation for the intervention of tissue adhesive (TA) to eliminate the home care nurse visit or trip to the community health unit for the dressing change after the first 24 hours and the post-insertion bleeding/oozing at the site.
The PICC insertion procedure was routine without any complications. The 4 Fr PICC and the securement device (subcutaneous anchor as per standard protocol) were inserted without difficulty. Follow-up included a phone call with him the next day to see if there was any bleeding or oozing at the catheter insertion site or any skin irritation at the insertion site or surrounding area. RC did not have any reports of the listed issues or any other complaints. Another phone call was made on day 7 at time for first dressing change and again, RC did not have any reports of complications or complaints with the dressing or TA at the site. Consequently, RC was able to complete his 14 days of home IV antibiotic therapy without any issues.
RC is one of many patients that is able to experience the benefits of TA at the PICC site.
Evaluation summary
45 patients (23 female, 22 male; age range: 22-67 years). A standardized protocol was established for the evaluation:
All patients were reviewed after 24 hours, 96 hours and at
day 7 hours to assess status of PICC site: bleeding, no bleeding; dressing intact, non-intact.
Results
Of the 45 patients, 42 (93%) had intact dressings and did not have bleeding at the site 24 hours, 96 hours and day 7 post.
The three patients that did not meet the criteria for TA application had the following clinical conditions that impeded the ability to achieve haemostasis after 6 minutes of direct manual pressure: chronic kidney disease, post-cardiac surgery on high dose anticoagulants, and haemophilia, dependent on factor product for coagulation.
The product we are using is SecurePortIV (Adhezion Biomedical) - a tissue adhesive (2-octyl Cyanoacrylate) labelled for vascular access protection and securement. It is now being used directly at the site, covered with a transparent film dressing, and is changed at day 7 or weekly. The positive outcomes from this small evaluation using SecurePortIV at the insertion site has allowed us to eliminate the 24-hour dressing change and therefore we have experienced savings on supplies, nursing time and an increase in patient satisfaction.
Guidance on application
Until recently, instruction on how to apply tissue adhesive to VADs has been limited because it is used primarily on internal and external tissue (Corley et al, 2017). Now that tissue adhesive has been given European CE mark approval for use with VADs, manufacturers are providing guides to application.
One example of this is the SecurePortIV (Adhezion Biomedical LLC). The product is available in an easy-to-use applicator that allows small drops to be applied at the insertion site. This allows the adhesive to pool around the catheter and create a bond between the device and the skin at the insertion site. The remaining adhesive may be spread on the skin around the insertion site to make the dressing more secure.
Removal of adhesive occurs naturally over 5–7 days. Earlier removal may be accomplished by gently pressing any hydrocarbon-based adhesive remover pad over the insertion site for between 30 seconds and 1 minute to saturate the area where adhesive is present. This will soften the adhesive and allow the device to be removed easily. To avoid skin irritation, the skin should not be rubbed with adhesive remover.
Considerations
Reapplication of CA tissue adhesive for long-term use is not well studied and there have been some reports of the product building up on catheter tubing. More evidence is required before recommendations for application on subsequent dressings can be made (Corley et al, 2017).
The impact of CA tissue adhesive on catheter materials has been considered and tested. An experimental study (Di Puccio et al, 2018) looked at the effect of CA tissue adhesive on a variety of polyurethane and silicone catheters. Following evaluation at 4, 8 and 12 weeks, no changes were observed in the materials.
Instances of skin damage have been reported with incorrect removal of CA tissue adhesive and education for staff in removal techniques should be considered. There are also now commercially available adhesive removers that can loosen CA glue quickly (Corley et al, 2017). It has been suggested that CA tissue adhesive may not be suitable for patients with sensitive skin or skin conditions as the effects of tissue adhesive in these cases has not been studied (Corley et al, 2017).
Conclusion
Evidence shows that the use of second-generation CA tissue adhesive has a role to play in reducing complications associated with VADs. It should be considered as a new tool for the vascular access toolbox, with cost and time saving benefits as well as the potential to assist in the reduction of CRBSI.