Background: The aim for this dissertation is to undertake a current systematic literature review to ascertain the comparison of Tissue adhesive (TA) and sutures used for wound repair on traumatic lacerations. To evaluate both the advantages and disadvantages of the two selected wound closure methods.

Management of these lacerations firstly involves cleaning the wound appropriately and then closing the wound edges until natural healing occurs. Without proper closure, the patient is at risk of increased infection and excessive scar formation, which is often referred to as unsightly and dysfunctional appearance. This could result in a poor cosmetic outcome for the patient (Hollander and Singer, 1999, p.356).

Traditionally, closure of these lacerations has been accomplished using sutures (needle and thread), which either dissolve after a period of time or require a second visit to the primary care centre for removal. The insertion of sutures can be painful and will often require a local anaesthetic (LA) agent to reduce this pain. Local infiltration of the wound with LA itself can be painful as this is also involves a needle. Skin adhesives are a liquid monomer that once applied quickly forms a strong bond over the approximated edges. In the past only small selected wounds have been closed using TA’s.

Method: A systematic review of literature was performed using a wide range of sources, complemented by a hand search of key journals. Databases including Pubmed, Cinahl, Science Direct, Cochrane Library and Google Scholar were used. Key words were searched using the following terms: Tissue adhesive, sutures and lacerations. In turn a critical appraisal skills programme (CASP) tool was used to help make sense of all the literature researched for this review.

Findings: The results showed the time for skin closure using TA is faster versus other skin closure devices. When all the studies are combined, the overall infection rate after wound closure with TA versus other SWC methods is slightly higher. Patient cosmesis, studies report that cosmetic outcome using a wound evaluation score is little or different when using TA against other skin closure devices even when comparing the results at a three month follow up.

Conclusion: The review demonstrated that many health care professionals (HCP) believe that the use of TA is limited to short, simple lacerations in children. The current review clearly demonstrates that the newer TA can be used successfully in a wide variety of clinical settings for multiple types of wounds covering most of the surface of the human body in both adults and children. TA has been used successfully for long as well as short lacerations. Prior knowledge and practical experience specific to wound closure with TA as well as appropriate wound selection and preparation will help achieve optimal results.

This chapter provides an insight into the background of the literature review subject. Identifying the comparison of tissue adhesive (TA) and sutures for lacerations and their use within the urgent care environment by emergency care practitioners (ECP’s). The aims and objectives of the review will be addressed. Certain key terms have been described which will enable the reader to have a better understanding of the discussions surrounding this literature review.

Background

Historically there has been no provision for wound care management including closure offered by local Ambulance Service Trust’s. Patients requiring this would have needed to attend their local emergency department (ED). In 2004 the department of health commissioned a strategic review of National Health Service (NHS) ambulance services in England. In doing so, this report “Taking healthcare to the patients” set out a program that would see a proactive, efficient and dynamic Ambulance Service (DH, 2005), this is also known as the “Bradley Report”.

The development of the emergency care practitioner (ECP) from both the Bradley (DH, 2005) and the NHS modernisation agency report (26th October, 2004) aimed to do just that. Emergency care practitioners (ECP’s) would be able to deliver high quality urgent care and to treat more NHS patients with injury or illness within there own homes. Wound care management including closure is just one of those aspects that the ECP’s are using throughout the NHS ambulance Trust’s today as a recommendation of the report (DH, 2005, p.67).

For primary closure of uncomplicated, low risk lacerations, the technique of closure and the material used need to be considered. There are currently several different ways in which accurate approximation of the skin edges can be achieved. The most common methods used are sutures, tissue adhesive, steri strips and skin staples (Purcell, 2003, p.200).

This literature review looks at just two methods namely TA and sutures as these are widely used by ECP’s when providing urgent care for the management of lacerations.

The use of other standard wound closure (SWC) options includes skin staples and steristripes. Staples are currently not widely used outside of secondary care and steri strips are not recommended for wound closure on heads. They must be kept dry and will not remain attached in areas where there is hair, and have a lower tensile strength than other SWC methods (Purcell, 2003, p.201).

Tissue adhesive is a liquid monomer that hardens rapidly on contact with tissue surfaces. A strong but flexible film that bonds is created over the apposed wound edges. There are several potential advantages over SWC methods. It is easier to use to, causes less pain, shorter time to apply and does not requiring a follow up visit for removal. Sutures are mainly a synthetic, non absorbent nylon (ethilon) or polypropylene (prolene) material that requires sterile instruments and technique to apply. Both methods are reported to have advantages and disadvantages in the management of wound care (Purcell, 2003, p.205).

Aims

To undertake a current systematic literature review to ascertain the comparison of TA and sutures used for wound repair on traumatic lacerations.

1-3 Objectives

To compile an effective search strategy to locate the relevant literature from within the last 10 years to include books and general guidelines from relevant organisations.

To choose and analyse the current relevant literature using the critical evaluation tools.

To provide a balanced and unbiased evaluation of both the benefits and disadvantages of the selected wound closure methods.

Provide recommendations for the practical aspect of wound closure to facilitate evidence based practice (EBP).

1-4 Rationale

The rationale for this literature review extends from the authors clinical experience, working as a paramedic and as a student ECP. To ensure that clinical practice reflects a contemporary evidence base for proper management and wound closure techniques.

Chapter Two Methodology

This chapter examines the methodology and justification of a literature review, explaining why the selected methods are appropriate to the predefined question. Ethical considerations are also addressed.

Systematic Literature Review

Mulrow, Cook and Davidoff, (1997, p.389) defines a systematic review as “concise summaries of the best available evidence that address the defined clinical question”.

An effective literature review requires a strict protocol to ensure that the review process undertaken is systematic by using explicit and rigours methods to identify, critically appraise relevant studies in order to answer a predefined question (Aveyard, 2007, p.11).

It is often difficult to obtain permission from the required ethics boards for other research techniques, such as primary research or audit which can require the use of patient data. The timescale required to gain permission from these boards can be long. A literature review will provide the reader with a summary of a number of selected articles and studies covering the same topic. This enables the reader to make decisions based on one review rather than having to gain information from other sources. This project is looking at a well researched area, with a substantial amount of studies and reviews.

2.2 Research

When undertaking a project it is important to utilise the correct design to answer the predefined question most effectively. Outlined below are explanations of why a systematic literature review was the most appropriate choice amongst other methods.

Literature review

Evidence base practice (EBP) ensures that healthcare is based on up to date, reliable and relevant evidence. Advocated by Rosenberg and Donald (1995) is a four step approach in evidence based medicine, these being:

Formulate a clear clinical question from a patient’s problem.

Search the literature for relevant clinical articles.

Evaluate (critically appraise) the evidence for its validity and usefulness.

Implement useful findings in clinical practice.

Evidence based medicine is defined by Rosenberg and Donald, (1995, p.1112) as, “the process of systematically finding, appraising and using contemporaneous research findings as the basis for clinical decisions”. Undertaking a literature review fulfils this goal and provides the best possible care to patients.

Research Project

The aim of a research project is to derive new knowledge through primary research. The best way to answer the project question given the time restrictions was not by undertaking a single study. Instead, more benefit could be gained by reviewing previously published research in order to consider all aspects of the subject. Primary research requires ethical approval from the appropriate boards from within the NHS and the University of which time restrictions applied.

Clinical Audit

Clinical audit is defined as “a quality improvement process that seeks to improve patient care and outcomes through systematic review of care against explicit criteria and the implementation of change”. Audit measures performance against “gold standards” and ensures that what should be done is being done. If the “gold standards” are not being met then audit provides a framework to enable improvements to be implemented. Currently ECP’s adapt national standards set out by the skills for health framework under the competences of emergency, urgent and scheduled care (Competency application tool, n.d.).

A clinical audit would involve collecting clinical data on current practice and comparing it against the gold standards. While clinical audits are invaluable for improving clinical practice the use of audit was deemed not useful to answer the chosen question. Conducting a clinical audit was considered but decided it was difficult to arrange due to the time restrictions needed to gain permission from the appropriate ethics board.

Undertaking a systematic literature review

Sources of information

To make the systematic review as comprehensive as possible, information was obtained from many sources:

Books:

Books can be a useful source of peer reviewed information, particularly when researching context or background to a topic. There downfall is that they become outdated very quickly. A few books were found and they proved to be valuable for this review. Books were not the main source of evidence for this project.

Journals:

Journals provide a higher quality of evidence as they are peer reviewed and are reviewed prior to publication by experts in the relevant field. Such journals used included: The American journal of surgery, Journal of plastic surgery of England, British medical journal and the Nursing standard journal

Databases:

Databases comprise of documents including original research, editorials, reports and review articles from various journals. The databases reported to be the most commonly used by students are the British nursing index, MEDLINE and Cochrane library amongst others (see table 1), (Ely & Scott, 2007, p.61). Google scholar and the Cochrane library were utilised to some extent to complement the database search.

Table One – Databases commonly available to nursing and medical students.

British nursling index Database that covers most popular English language nursing journals

CINAHL Cumulative index to nursing and allied health

Cochrane library NHS electronic library for health

Medline US national library of medicines, mostly English language

It is worth while in mentioning that other databases are available and just as useful but not included within the above table. It can be said that other databases can look upon the same topic offering different perspectives.

Internet search engines:

Google scholar was used as it allows searches across many disciplines and sources at once; this ensured a wider breath of literature.

Manual search:

In addition to searching databases, many valuable references were also found through hand searches, how ever this method is extremely time consuming and offers limited scope for this project. The availability of online journals and databases form the internet proved to be a better option in finding the data required.

Search terms

A predefined research question has the added benefit of containing the words required for an online search. These words or search terms are known as key words, descriptions or identifiers. The project question was broken down into several key sections and each was searched for individually (Fink, 2005, p.22).

Boolean and truncation

Boolean operators are words (connectors) that are placed between search terms to narrow or expand a search. The connectors AND (retrieves all records that contain all the search terms), OR (retrieves all records that contain any of the search terms) and NOT (eliminates a search term or group of search terms) are used to gain appropriate responses (Ely & Scott, 2007, p.67).

Most electronic databases allow for a symbol to be used at the end of a word to retrieve variant endings of that word. This is known as truncation. Truncation allows you to search the root form of a word with all its different endings. Using truncation will broaden the search, for example, wound* will retrieve: wounded, wounds and wounding (Fink, 2005, p.28).

Reviewing and refining the search

It can be difficult to undertake a comprehensive literature search and ensure the information gathered is closely related to the predefined question. Therefore any search terms retrieving large amount of results were removed, or additional terms were introduced to focus the search more precisely (Fink, 2005, p.23).

Inclusion and exclusion criteria

Only studies in the English language were used. To ensure that only the most current evidence was included, the majority of literature used was from the last ten years. Other literature was excluded because of restricted access to some resources. Article abstracts were examined for the criteria and the full article printed directly from source. Hard copy articles were retrieved from journals at the university library.

2.4 Ethics

The information used in this review is obtained form publically available sources and does not contain patient details. As a result of this ethical approval was not

necessary. The appropriate research ethic checklist was completed and submitted to the School of Health Sciences and Social Work (SHSSW) at the project proposal stage prior to starting this literature review. Consistent referencing to the Harvard APA style has been adopted accordingly.

2.5 Validity and reliability

The literature establishes how effective the literature review is, so every effort was made to include as much relevant literature as possible in order to draw balanced, reliable and valid conclusions.

Critical evaluation of literature

Once all the literature had been collected, it was critically evaluated, which is defined as “a systematic way of considering the truthfulness of a piece of research, the results and how relevant and applicable they are” (Marshall & Kelly, 2007, p.12). This was achieved through using tools from the critical Appraisal Skills Programme (CASP) (see appendices 1) (2006), the results are displayed on the literature summary chart (see appendices 2).

Chapter 3 Literature Review

This chapter contains information on the critical review.

Literature review

Acute traumatic wounds, including lacerations are one of the most common reasons for people self presenting to local district hospital emergency departments (ED) (Sibert, Maddocks and Brown, 1981, p.225). Figures for ED attendances in England for lacerations in 2008-09 stood at 663,475 or equivalent to 8.5% of the total 13.8 million primary diagnoses recorded for that period (A&E, 2010). The management of such conditions is usually straightforward. Although a thorough assessment and prompt treatment is essential to prevent short-term and long-term complications for the patient. The correct closure method for wounds reduces the risk of infection and excessive scar formation (Hollander and Singer, 1999, p.358).

The management of both traumatic and surgical wounds has had a chequered history even from the earliest record of wound closure. This dates back to 1100 BC, when abdominal incisions on mummies were closed with pieces of leather ligatures (Majno, 1975). There have been very few additions to the world of wound closure since then. What has developed in the way of wound closure devices includes sutures, staples, adhesive tapes and TA which have now been used for more than thirty five years (Cooper, Joyner & Sheere, 1959, p. ).

Primary closure or immediate approximation of wound edges of lacerations should be performed without delay, certainly when less than six hours old and considered at low risk of infection. Wounds at high risk of infection are dealt with according to the time of presentation to the health provider. For example high risk wounds presenting between six and 12 hours should be cleaned and reviewed prior to closure. Advice from clinical knowledge skills (CKS) on wounds presenting over 24 hours old could be left to heal without any form of formal closure. The specific choice of material for closure depends on the intended function, the location of the wound and the preference of the health care practitioner (Vidyarthi & Gupta, 2003, p. ).

There have been multiple studies and reviews that have compared TA against other standard wound closure (SWC) methods. A Cochrane review found 13 relevant studies. Of these 13 only 11 studies directly compared adhesive with SWC and met the inclusion criteria for their review. The other two studies compared TA against other different types of TA of which were not relevant for this review. The results of the studies looked at different aspects of the SWC methods, these included; cosmetic visual analogue scale (CVAS), wound evaluation score (WES), pain scores, procedure times and ease of use (Farion, et al, 2007. p.6).

The CVAS was developed to assess short term cosmetic outcome of laceration repairs in clinical trails. It is reported to be reliable by those using it on a regular basis. It simple measures the appearance of a scar by using a 100mm line with zero being the “worse scar imaginable” and 100 being the “best scar imaginable”. Scaring is simple described as the consequence of dermal injury due to trauma or surgery (Quinn, et al, 1997, p.1528).

There are different types of scars ranging from a fine line to abnormal and pathologic, these can have functional, cosmetic and psychological consequences. Assessment is important for monitoring scar evolution and treatment efficacy. The European tissue repair society recommends three different assessments that should be performed at the end of the first, second and third month after wound closure. These simply look at the general features of the scar including colour and vascularity. In addition the width and height of the scar is compared, finally looking to see if hypertrophy is visible (Vercelli, Ferriero, Sartorio, Stissi and Franchignoni, 2009, p.2055).

Living with scarring can be particularly challenging, especially in today’s society that places importance on physical attractiveness. Visible areas such as the face are at most risk (McGrouther and Ferguson, 2009, p.715).

The WES assesses six clinical variables of each scar: absence of step-off, contour irregularities, wound margin separation greater than 2mm, edge inversion, excessive distortion, and overall cosmetic appearance. In a similar way to the CVAS the WES is graded using a scoring system of one or zero for each element, with six being considered “optimal”, and scores below five would be classed as sub-optimal (Hollander, Singer, Valentine and Henry, 1995).

While cosmesis is considered an important outcome for both patients and health care providers, other measures should be considered before selecting TA as an appropriate alternative to sutures and other SWC methods. The WES type of scoring assessment is necessary and helps provide the right type of treatment as required. Evidence based practice for recommendations in scar therapy is limited (Mustoe, et al, 2002, p.560).

Of the 11 studies Farion, et al, (2007) states that within the studies two different types of TA were used, both of which reporting similar outcomes, with five butylcyanoacrylate (Histoacryl TM) (Barnett 1998; Goktas 2002; Quinn 1997; Schultz 1979; Simon 1997) and six with octylcyanoacrylate (Dermabond TM) (Bruns 1998; Holger 2004; Mattick 2002; Quinn 1998a; Singer 1998; Zempsky

2001). The standard wound closure method was sutures, appearing in seven studies (Barnett 1998; Goktas 2002; Holger 2004; Quinn 1997; Schultz 1979; Simon 1997), adhesive strips in two studies (Zempsky 2001; Mattick 2002), and a mixture of closure methods in the remaining two studies (Bruns 1998; Singer 1998), though the majority of participants received sutures. In one of the studies comparing tissue adhesive with sutures (Holger 2004), the tissue adhesive was actually compared with two types of suture (i.e., absorbable and non-absorbable).

The procedure time and pain score were reported to be as favourable towards TA with little or no difference in the cosmetic appearance. Many studies including Quinn, et al, 1998, p.1528, report using a visual analog scale (VAS) system for recording pain experienced by the patients. This is very similar to the CVAS and WES systems in that zero is recorded as no pain and a score of 100 is recorded as the worst pain possible. Based upon the (Bernard, et al, 2001) study, TA has demonstrated that it may not be as effective in achieving optimal cosmesis for lacerations that are generally under greater tension. These would normally be closed with 3-0 or 4-0 sutures. The application of TA is faster than other SWC methods, mainly due to no time required to wait for the onset of anaesthesia as used in other SWC methods (Singer, et al, 1998, p.98). It is reported that TA is less painful than other SWC, although Zempsky, Grem, Nichols, & Parrotti, (2004, p.552), mention in their review that some patients experienced a burning sensation on administration of the TA. This issue could be remedied with the application of a topical anaesthetic prior to using the TA.

The risk of a needle stick injury is eliminated by 100% for health care providers when using TA. Quinn, Et al, (1998, p.645), report that they found no difference in clinical characteristics between TA and suture repair in 77 of the original 136 patients who completed the one year follow up. They suggest that one year should be the standard for cosmetic evaluation although there is no scientific evidence to support this. Based upon that collagen has matured and a wound is close to 100% of the skins original tensile strength. During this time dynamic changes in collagen maturation and inflammation response occur that can affect the eventual cosmetic outcomes.

A total of 834 lacerations within nine of the studies recorded complications with the wounds ranging from simple erythema (redness) and dehiscence (wound re-opening, failing to heal) when using TA alone. The erythema was found to present on wounds in patients treated with other SWC methods.

A review published in 2004 by the American Journal of surgery showed results of four random controlled trail (RCT) using meta-analysis for the time taken for the closure of lacerations and infection when using TA against other SWC methods. The RCT highlights that closure by TA only is 3.6 minutes faster than other SWC methods. Within the same review five RCT were found looking at infection within wounds after closure. The overall infection rate after wound repair with TA was 13 of 907 (1.1%) versus 7 of 934 (0.7%) for all other methods of closure (Singer and Thode, 2004, p 239).

Farion, et al, (2007) state that the supply cost are not mentioned in the majority of the studies reviewed. Only two studies published the economic analyses of TA against other SWC materials. The first analysis (Osmond, 1995) compared the personnel time, supply costs between nonabsorbable sutures, absorbable sutures and TA, how ever this was completed using data from 1993 costs. Overhead costs from the ED and costs associates with complications were not included within the final report. Absorbable sutures were found to be 2.4 times more costly than TA, while nonabsorbable sutures were 6.8 times more costly due to return visits to the ED. The second analysis (Zempsky, 2005) compared three methods of wound closure; these were TA, sutures and steristripes for simple wound closure without complications.

The authors used literature to estimate the costs of the products used and the health care provider’s times. They concluded that of the three products steristripes had the lowest cost per laceration and TA was found to be the most expensive alternative. It is evident that an updated cost analysis is now needed.

Chapter 4 Discussion

4.1 Discussion

This chapter provides an analysis of results detailed in the previous chapter. Towards the end of the chapter the advantages and disadvantages are discussed.

The aim of this paper was to conduct a systematic review of qualitative literature to explore the comparison of TA and sutures used for laceration closure by ECP’s. There is a tremendous interest and increasing research area connected to TA. The use of TA has become very popular. Numerous studies have shown the utility of TA in uncomplicated laceration repair. The ultimate goals of wound closure as discussed by Singer, et al, (1998, p.97) are to achieve haemostasis; this is considered to the primary goal. The secondary use is to avoid infection, restore function to the involved tissues by means of sealing to appose tissues. If applied correctly it should achieve optimal cosmetic results with minimal scarring for the patient.

There is a third use mentioned in various reports and is something that would be very beneficial to patients and easy for ECP’s to use and that is the potential to serve as a delivery system. TA could conceivably be engineered for slow, localized release of pain medication, antibiotics. Ryou and Thompson, (2006, p, 36) simple state “The future of tissue adhesives can be as broad as the imagination”.

Wound closure using TA is faster than with standard wound closure devices as sutures. The amount of time saved is magnified in proportion to the length of the wound, thus the greatest time savings were for the longest wounds. A wound treatment using SWC methods is reported to take on average 50 minutes, including inspection, anaesthesia, closing, clearing of equipment and removal of sutures. This is compared to 10 minutes for closure by TA. There are no statistically significant differences in wound infection and dehiscence rates regardless of type of closure device used. Lacerations closed with TA’s have a low and acceptable rate of wound infection and dehiscence (Singer and Thode, 2004, p.244)

4.2 Reported advantages and disadvantages of TA and sutures

Adhesives that are used today have many advantages over standard wound closure devices, in addition to their rapid application. They are relatively painless to apply and may not require the use of painful local anaesthetics. They also slough off spontaneously within five to ten days eliminating the need for suture removal. TA have also been shown to have a barrier function against infection and serve as a wound dressing that creates a moist wound environment enhancing wound healing. As the adhesives do not require needles, the risk of an accidental needle stick injury is eliminated. The idea of “simply” gluing two tissues together or plugging a bleeding hole is not a reality in urgent care. The application of these materials is more complex than some health providers assume. The literature shows that using TA correctly does improve the situation but also suggests that using them incorrectly could make the problem worse. If the TA hardens before the tissue is approximated, it would act as a barrier to wound healing (Reece, Maxey and Kron, 2001, p, 42).

The direct cost of TA can be generally higher that other wound closure devices. How ever, the cost saving is largely attributed to the reduced need for a patient to be followed up, practitioner time and supplemental supplies such as suture sets. The disadvantage of TA is their reduced tensile strength, thus only being used alone for low-tension lacerations whose edges are easily approximated with the operator’s fingers or forceps. This is regardless of how long the laceration is. TA is comparable with 5-0 sutures but should not be used alone in high tension areas (Singer & Thode, 2005, p 243).

The TA is also particularly well suited for the closure of flaps and fragile skins as they do not tear through tissue or strangulate them, as do sutures. This makes TA useful for closure of narrow flaps and pretibial skin lacerations. Traumatic lacerations will occur in unsterile conditions which could carry the risk of infection. Obviously the TA should not be used to close contaminated or infected lacerations with out first being irrigated and the wound is completely clean (Singer and Thode, 2004, p 245). Infection could be trap inside the laceration if not cleaned appropriately which could cause it to spread. Antibiotics for contaminated wounds and secondary care referral must be considered.

It is important that the HCP to fully recognize infection to a laceration. Only by taking a full and accurate history prior to undertaking any treatment will differentiate infection from the normal inflammatory response that follows injury (Cole, Lynch and Reynolds, 2008, p.386).

Table Two – Summary of advantages in using tissue adhesive.

Maximum bonding strength at two and a half minutes

Equivalent in strength to healed tissue at seven days post repair

Fast repair time

Better acceptance by patients

Water resistance covering

Does not require removal of sutures

There is less traumatic tissue healing

Application of TA is a manual skill that is easily acquired but practice and training are helpful to master control of the applicator and adhesive viscosity. Wounds should be evaluated and prepared following local practices. The laceration wound should be dry and adequate haemostasis is necessary prior to w