Wounds, whether due to lacerations or incisions, disrupt the integrity of the skin as the body’s first line of defense against infections. Blood vessels are similarly injured resulting in bleeding and significant bleeding if large blood vessels are involved. Hence, wounds must be managed promptly to promote hemostasis, prevent infection, maintain normal body function, and achieve the best cosmetic results (Pfenninger & Fowler, 2010). The method of wound closure is an important consideration as certain methods are better suited for specific types of wounds.
There are various procedures employed in closing wounds, namely suturing, skin stapling, taping, and using tissue adhesives. Skin stapling has become a common alternative to suturing. It involves the application of titanium or stainless steel staplers to bring the wound edges together which facilitates healing. Approximation of the break in the skin allows platelets and white blood cells to do their work and promotes re-epithelialization or scar formation thus restoring skin integrity through primary intention (Pfenninger & Fowler, 2010). Recent innovations, such as absorbable staplers, and ease of use further make it a good management option.
Skin stapling is an important procedure in the management of wounds especially uncomplicated and shallow lacerations with straight edges and no significant tissue loss. There is no penetration through the wound unlike in sutures thus decreasing tension on the tissues that can interfere with the healing process. There are also claims that skin stapling is associated with a lower risk of wound infection. Further, it can be performed with ease with a much shorter wound closure time. For these reasons, skin stapling is a procedure that family nurse practitioners can successfully perform. Knowing the evidence-base also ensures that the use of this wound repair method is safe, effective, and appropriate.
Review of Evidence-Based Articles
Two articles supporting the procedure were located and retrieved. The primary criterion in choosing the articles was the research design and recency of publication. One study is a systematic review of systematic reviews with panoramic meta-analysis. The purpose of the study was to evaluate in a systematic manner the evidence pertaining to patient and health care provider outcomes when staples or sutures were employed in wound repair (Hemming et al., 2013). The studies reviewed were conducted in various surgical specialties. Hence, the other purpose was to determine the level of heterogeneity on which depends the possibility of presenting a pooled estimate of effects. Although no problem statement was explicitly reported, it can be assumed that it pertains to what the differences are, if any, in the operating time, hospital length of stay, and rates of SSI and post-surgical complications when sutures or staples are used.
The other study selected is a large multicenter randomized controlled trial comparing staples with sutures in terms of the rate of wound complications that included superficial surgical site infection (SSI). It was conducted with the purpose of validating whether the findings of trials in class 1 or clean surgeries, e.g. thyroidectomy, mirror those in class 2 or clean-contaminated surgeries, e.g. cholecystectomy, suggesting that research conclusions are generalizable across these two types of surgeries (Tsujinaka et al., 2013). Again, no problem statement was provided. However, it can be assumed that the study relates to what the differences are in the rate of wound complications and hypertrophic scarring following elective open gastrointestinal (GI) procedures when staples or subcuticular sutures are employed to close the incision.
Both systematic reviews and randomized controlled trials provide valid and reliable evidence especially when a clinician is considering which method of wound closure is more effective in regards to selected patient outcomes. In evidence hierarchies ranking the strength of evidence based on research design, the findings of a systematic review, meta-analysis or RCT provide Level I or Grade A evidence. This suggests strong support from the literature warranting a recommendation or guideline to adopt the intervention. The chosen articles are reviewed in greater detail below.
Study Design
Systematic review. The aim of a systematic review is to consolidate existing evidence across numerous randomized controlled trials (RCTs). It employs a set of criteria in choosing an RCT and considers the quality of such studies therefore taking into account the presence of significant bias in relation to findings. Systematic reviews generate conclusions that guide recommendations as to best practices in relation to a medical condition or an intervention. On the other hand, a meta-analysis involves the pooling of data sets from different RCTs in situations where the level of heterogeneity allows it. Doing so reduces bias from sampling especially in RCTs with small sample sizes. As such, the conclusion has a greater reliability while at the same time providing a snapshot of the evidence across different clinical settings.
Hemming et al. (2013) conducted a search of four of the largest databases wherein systematic reviews of medical interventions are most likely to be found. They also searched the reference lists of the studies with potential for inclusion in the review. To ensure the integrity of findings, only peer-reviewed research reports were included. Two reviewers independently assessed the titles and abstracts during the selection of potential studies. The articles were then screened using criteria ensuring the studies investigated the chosen outcomes, the independent effects of sutures and staples were determined, and it was possible to separate RCT findings from those of other research designs. A flow diagram depicts how the researchers narrowed down the potential studies to arrive at the sample.
The AMSTAR score which is a tool developed for systematic review was employed to evaluate the quality of the methodology of each study. As there was likelihood that different reviews included the same studies, the one with the highest AMSTAR score, and thus had the highest quality, was chosen (Hemming et al., 2013). The Forest plot was employed to summarize the treatment effect, number of observations, and number of studies reviewed. To optimize the review, data was further stratified by relevant category, such as type of closure or the use of sutures and staples for skin or internal closure, whenever possible. The degree of heterogeneity by type of closure, research design, and statistics was measured using three different tools. Publication bias was assessed using the funnel plot.
Randomized controlled trial. An RCT, especially when high-quality research methodology is used, i.e. with randomization, blinding, standardized protocols, and a sample size yielding sufficient power, can generate strong support to a given intervention. The reason is that bias from different sources, such as the characteristics of the sample or variations in implementing the intervention, is eliminated or minimized. The result is high certainty that the outcome observed is attributed to the intervention. As such, an RCT can be employed to establish cause and effect. In regard to wound repair, it is possible through an RCT to determine if the type of closure leads to certain outcomes.
Tsujinaka et al. (2013) conducted a three-year phase III RCT of adults undergoing elective open surgery of the upper or lower GI tract in 24 different hospitals in Japan. Phase III trials entail the use of sample sizes greater than 500 and are often used to determine the efficacy, adverse effects, and complications of a drug or intervention. Using a computer application to reduce the risk of bias, the participants were randomly allocated to the staple arm or subcuticular suture arm prior to the procedure. Gender, type of surgery, and type of institution were considered in the randomization to achieve balance.
Although blinding both the researchers and the participants as well as employing placebo control add rigor to the study, these methods are impractical when the issue of wound closure is concerned. An open label study is more appropriate. Thus, the investigators who were also the surgeons knew which arm their patients were assigned to. Participant blinding was also not performed because it would violate the patient’s right to informed consent and the principles of research ethics (Tsujinaka et al., 2013).
Moreover, the protocol for skin stapling and subcuticular suturing were standardized (Tsujinaka et al., 2013). An instructional video of how each procedure should be done was made available and was also demonstrated in meetings. As the study lasted for three years, investigators underwent re-education on the techniques to ensure continued adherence. Infection control procedures were also standardized through the adoption of guidelines from the Centers for Disease Control and Prevention (CDC). The investigators were asked to consistently use the same types of sutures and staples. However, it was not possible to standardize standards for skin preparation, antibiotic prophylaxis, irrigation, intraoperative care, and wound dressing and management across the participating hospitals.
Wound complication and hypertrophic scarring were each operationally defined with standardization of the assessment, monitoring, and diagnosis of these two outcomes (Tsujinaka et al., 2013). For instance, investigator consensus was achieved in regard to what data should be considered in the diagnosis of different wound complications and hypertrophic scarring. Doing so contributed to the reliability of the findings of patient assessment and the accuracy of diagnosis.
Sample
In the systematic review, 11 studies met the inclusion criteria and only three studies had AMSTAR scores of below 5 while 2 studies scored 9. This means that relatively, the quality of the systematic reviews was moderate to high. There was no data on the demographic profile of the participants in the RCTs reviewed in the chosen systematic reviews. However, participants underwent different types of surgeries such as Caesarean section, appendiceal stump, and colorectal, ileocolic, or esophageal-gastric anastomosis (Hemming et al., 2013). There was variability in the sample sizes of the RCTs.
In the RCT, the sample consisted of 1,080 adults based on a power analysis showing that 530 participants for each of two arms yields a power of 80% at a significance level of .05 (Tsujinaka et al., 2013). The participants were 20 years old and up, and about 70% were male. Other inclusion criteria included having been scheduled for elective and open upper or lower GI surgery and sufficient organ function. Exclusion criteria were emergency surgery, use of laparoscopy, previous laparotomy, chronic medication with corticosteroids, active infections, blood clotting disorders, poorly controlled diabetes, insulin treatment, mental disorder, general poor health, and serious heart or lung conditions.
Both studies were conducted with adult participants in acute perioperative settings. In contrast, the patient population of primary health care includes children, adults, and pregnant women. Wound closure is typically done only in minor surgeries such as lacerations and excisions. While the RCT excluded persons with acute and serious conditions, the open GI procedures done were more invasive. At the same time, the participants and the participating hospitals were in Japan where standards and the physical environment within which care was provided may be dissimilar to the U.S.
Data Collection
In systematic reviews, there is no data collection similar to a primary research. The authors conducted a search of four major databases of medical literature ensuring that most, if not all, of systematic reviews published will be subjected to assessment for possible inclusion. As such, the study is representative of all systematic reviews on the topic. Another of the study strengths is the independent assessment and screening of the articles as there is less likelihood of bias. Secondary data is provided by the systematic reviews which may be evaluated separately or pooled. The quality of the systematic reviews was moderate to high increasing the reliability of the data provided.
Meanwhile, the RCT collected information from medical records and patient assessments. Medical records are reliable sources of data because they provide objective information. This is appropriate since the outcomes studied were wound complications and hypertrophic scarring. The strength of the data collection method lies in the standardization of the process of assessing and diagnosing patients. As such, there is greater confidence in the findings with knowledge that any of the investigators would have assessed a patient in the same way and come up with a similar diagnosis. However, a weakness is that the scale employed in scar assessment was the product of investigator consensus but was not validated.
Results of the EBP Articles
The systematic review found that across different surgical procedures, there were no significant differences in the hospital length of stay and rates of SSI and post-surgical complications between skin stapling and closure by sutures. Similarly, the RCT did not find a significant difference in wound complication rates and hypertrophic scarring between the two wound repair methods. The findings suggest that the effects of skin stapling approximate that of sutures. In both studies, however, the time it takes to close a wound was significantly shorter with stapling than suturing.
Personal Opinion
The systematic review of systematic reviews with meta-analysis provides a current picture of the evidence pertaining to sutures and staples in wound closure. In the same way, the RCT findings are also difficult to generalize to the primary care population despite the high quality of the trial. With the absence of RCTs comparing both methods in primary care, however, it is difficult to generalize the findings of the review in the said setting. The differences lie in the nature of surgeries performed, i.e. major or minor, the patient population, and the practice and physical environments. That the evidence shows neither skin staples nor sutures is superior over the other in outcomes means that other considerations need to be taken into account. For instance, the type of wound, skill level of the practitioner, patient preference, infection control measures, and facility policies and guidelines are additional information influencing the decision of wound closure method.
Updates Needed to the Procedure
Periodic reviews of the literature for current best practices in infection control in the management of minor wounds are important and must be accompanied by improvements in policy and practice. As minor surgery permits patients to go home after the procedure, it is also important to consider the evidence base for educating patients on wound care and management at home. Guidelines must also be developed on this aspect of care. Lastly, evidence on the best type of skin staple in terms of wound outcomes should also be determined to guide the choice of product, i.e. titanium or metallic.
Value of the Articles in Practice
Despite problems with generalizability, the benefit of the EBP articles is that they reveal a gap in knowledge as to the effectiveness of skin stapling in comparison with other methods of skin closure. Therefore, there is a need to initiate or support research on this topic in the primary care setting. The articles also emphasize that in wound management, the choice of closure method must be one of many considerations when the goal is to minimize complications such as infection. The procedure protocols used in the RCT attest to this. Skin stapling must be situated within the context of good infection control procedures and adequate patient education for wound care at home. Adherence to best practices in these areas must be ensured to bring about the best outcomes for patients in primary care.
References
Hemming, K., Pinkney, T., Futaba, K., Pennant, M., Morton, D.G., & Lilford, R.J. (2013). A systematic review of systematic reviews and panoramic meta-analysis: Staples versus sutures for surgical procedures. PLOS ONE, 8(1), 1-12. doi: 10.1371/journal.pone.0075132.
Pfenninger, J., Fowler, G. (2010). Procedures for Primary Care Physicians (3rd ed.). Philadelphia, PA: Elsevier Mosby. ISBN: 9780323052672.
Tsujinaka, T., Yamamoto, K., Fujita, J., Endo, S., Kawada, J., Nakahira, S., Mori, M. (2013). Subcuticular sutures versus staples for skin closure after open gastrointestinal surgery: A phase 3, multicentre, open-label, randomised controlled trial. Lancet, 2013(382), 1105-1112. doi: 10.1016/S0140-6736(13)61780-8.
