This study was conducted to resolve the problem of pin-site infections. With external fixation devices (EFD) being used more frequently and the infection rate for skeletal pins at times reaching 100%, this study is very important to the field of nursing.
The purpose of this study was to determine the incidence of infection according to pin-site cleansing protocol.
The main research question of this study, although not explicitly stated, is ‘What is the most effective cleaning protocol in order to reduce pin-site infections?’
Although not explicitly stated, the hypothesis of this study is that using a cleaning protocol, versus random or no care, will lead to fewer infections due to EFDs.
The dependent variable of this study was the rate and type infection of the pin-site.
The independent variables were the cleaning protocols:
(1) half-strength peroxide cleansing and gauze wraps;
(2) half-strength peroxide cleansing and Xeroform wraps;
(3) saline cleansing and gauze wraps;
(4) saline cleansing and Xeroform wraps;
(5) antibacterial soap-and-water cleansing and gauze;
(6) antibacterial soap-and-water cleansing and Xeroform gauze;
(7) stable dressings with no pin cleansing.
Conceptual Model/Theoretical Framework
This study was guided by a theoretical framework because, based on the available information regarding pin-site infections, it led the author to study cleaning protocols as a way to reduce infections. The nature of using EFDs, which go through bone and tissue, causes them to have a high rate of infection. Infections can lead to health complications, longer hospital stays, longer recovery rates, and higher treatment costs. In some cases, pin-site infections that are left untreated can be fatal. Additionally, there have not been very many studies regarding pin-site cleaning protocols and there has not been determined one method that is more effective.
Review of Related Literature
The literature review supports the need for the study by showing the lack of data and information regarding pin-site infections and preferred protocols to reduce infections. It also highlights how important this study is by detailing the need to reduce pin-site infections.
The literature review cites that in the past, studies regarding protocols for pin care have identified four factors of influence: method and frequency of cleansing, choice of dressing, use of an antibacterial agent, and degree of sterility required. However, these studies have shown a great amount of variability in the protocols used without any one method being designated as the most effective. Protocols have varied from hospital to hospital and nurse to nurse but there have not been conclusive studies on which cleansing methods are most successful in reducing infections.
The study design used is a quasi-experimental design as it does not involve random assignment but does include various protocols and the participants were not chosen based on any other factors than that they had EFDs and had recently had surgery. This type of design is appropriate for this study because, since the purpose of this study is to look at pin-site infections, it could not have been a random assignment study; it required that all of the participants have EFDs.
There are many threats to the internal validity of this study, especially since the choice of participants was made without much discrimination. Perhaps one of the greatest threats is regarding the placement of skeletal pins or EFDs. The literature review cited that, although there had not been specific studies that addressed pin size, large pins and pins that pierced greater amounts of issue were more problematic and had a greater rate of infection. If all or most of the pins that were treated with one protocol were larger or went through more tissue, that cleansing method may seem to be less effective.
Another possible threat to internal validity is the lack of uniformity among operations and pin placement. Stability and anchorage of the pin was another characteristic that was cited in the literature review as impacting the rate of infection of pin-sites. Since this study was carried out in two medium sized hospitals (500 beds and 200 beds), the implication is that there would be a few doctors operating on the participants. Because doctors’ methods vary greatly, some doctors may have anchored the pins better, which could reduce the rate of infection. Therefore, a method that is not very effective could be reported as being more effective because the pins under that protocol had greater stability.
There are also many threats to the external validity of this study. Hospitals vary greatly, both within a country and throughout the world thus unless a very specific protocol is followed in all stages of the study, it is difficult to come to very many conclusions which can be generalized. One of the greatest weaknesses of this study is that it was conducted in 2 hospitals. This creates more problems for validity than if it had been only conducted in one hospital because, as previously mentioned, hospital protocols and methods vary greatly thus there could be greater problems with external factors influencing the results than if it were simply conducted in one hospital. At the same time, because the study was not done in more than 2 hospitals it cannot be generalized that results would be similar in all hospitals.
Another issue regarding external validity is that this study was conducted in 2 hospitals in different parts of the United States. Since care can vary depending on region and country, this study may not accurately reflect what would occur in other parts of the United States or in hospitals worldwide. Methods of caring for pin-sites may vary greatly, for instance this study required that pin-sites be cleaned twice a day, something that may not be the standard in other hospitals. Also, the materials used, such as Xeroform wraps, may not be used in other hospitals or perhaps there exist cleansing protocols that were not considered in this study.
Sample and Setting
The original sample size of this study, which was to be performed at 10 sites, would have been large enough to validate this study. However, because this study eventually was conducted in only 2 hospitals, with an initial sample size of 101 participants (93% participation rate) and with 93 patients participating overall, the sample size was only large enough to come to some preliminary generalizations.
According to the sample demographics of this study, “participants were similarly distributed across three age groups”; there were, however, nearly twice as many males participating as there were females although the study attributed this to “reflecting the gender ratio common to trauma”.
The data collection for this study, which was largely the responsibility of the primary investigator or the site coordinator, was appropriate for this study because, aside from the one sheet that was the duty of the patient, it dictated a certain sense of uniformity in the data collection.
Identification and Control of Extraneous Variables
The extraneous variables in this study, as outlined in the study, were: pin-site location, age, gender, concurrent injury, medical problems, study site, location of fixator, pins placed under power, being allowed to shower or swim, and type of fixator used.
There is no indication that any of the extraneous variables were controlled for in this study although fracture type, patient and medical demographics, extremity involved, type of fixator, type of pin, and showering/swimming allowances were recorded in the patient charts.
The primary instruments in this study, the cleansing and wrapping materials (half-strength peroxide, gauze wraps, Xeroform wraps, saline, antibacterial soap, water, and stable dressings) were adequate for use in this study based on the literature review, which identified these protocols as the most commonly used for cleansing pin-sites. These protocols were also the most often used in the original 10 sites of this study. This shows that these instruments are valid, reliable, and appropriate to this study. Two other instruments, chlorhexidine gluconate and chlorhexidine complexed with lipid-stabilized hydroxyapatite were stated in the conclusions as other possible instruments.
Data Collection Methods
Since the data collection for this study was largely the responsibility of the primary investigator or the site coordinator it allowed for a greater sense of uniformity in the data collection. This allows for more confidence in the manner in which the data was collected. The data collection procedures were appropriate because they used a variety of methods in order to ensure accuracy. Both hospitals used a rating scale that was adapted from Children’s Mercy Hospital in Kansas City, Missouri. This ensured that both hospitals would be rating the infections using the same scale. Additionally, five certified nurses determined content validity.
The rights of the subjects in this study were protected in a variety of ways. All patients had to sign consent forms and were informed of the possible outcomes with usual pin-care protocols, including the rates of infection. Confidentiality was guaranteed through the assignment of code numbers and only the researcher was aware of the names of the participants.
Data Analysis Procedures
The data analysis procedures were appropriate because they included a variety of factors, were analyzed by more than one medical professional, and because the study clearly outlined the guidelines for grouping the different types of infections.
The analysis procedures were appropriate in so much as they maintained uniformity by using the same data collection methods, by using second opinions, and by providing guidelines for the classification of infections.
One of the major strengths of scientific merit of this study is that it involved a variety of cleansing protocols, thus allowing for a wide variety of results. This shows that there was not a bias in the study that isolated one or two protocols.
Another strength is that the data collection was well controlled and thoroughly regulated. Since both hospitals used the same form (which the study notes has since been adapted by other hospitals in order to continue monitoring of pin-site infections) and infections were observed by more than one medical professional, the likelihood of accurate data collection is very high.
One of the major limitations of this study was the very small sample size used. In the end, there were between 12-15 participants in each protocol group, which greatly disqualifies any strong conclusions made by the study.
Another limitation is the fact that many of the external factors were not controlled for and were not part of the final analysis. Since some of these factors, such as concurrent injuries or medical problems could greatly impact the influence of the cleansing protocols this could be considered a great limitation on the study’s scientific merit.