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Abstract

BACKGROUND:

Pressure injury (PI) is a local injury of the skin and/or soft tissue located at the bone caused by medical or other equipment and is common in long-term bedridden patients.

OBJECTIVE:

To investigate the clinical effect of Urgotul foam dressing in the treatment of stage 3 $\sim$ 4 PI and deep tissue PI.

METHODS:

A total of 38 patients with stage 3 $\sim$ 4 PI and deep tissue PI admitted to Jinan Central Hospital from January 2016 to December 2018 were selected and randomly divided into a control group (dressing change plus silver ion cream dressing) and an observation group (dressing change plus Urgotul Absorb non-border foam dressing), with 19 cases in each group. After 4 weeks of treatment, the pain intensity during dressing change and the treatment efficacy for PI wounds were compared between the two groups.

RESULTS:

There were no differences in gender ( $P=$ 0.740), age ( $P=$ 0.130), single wound area ( $P=$ 0.673), consultation department ( $P=$ 0.972), stage ( $P=$ 0.740), presence of undermining ( $P=$ 0.721), deep tissue PI ( $P=$ 0.721), and systemic antibiotic therapy ( $P=$ 1.000) between the two groups, which were comparable. The treatment effect of the observation group was better than that of the control group ( $P=$ 0.003), and the pain score of the observation group was lower than that of the control group ( $P<$ 0.001).

CONCLUSION:

Urgotul Absorb non-border foam dressing has a good effect in the treatment of stage 3 $\sim$ 4 PI and deep tissue PI and can relieve patients’ pain, and is thus worth promoting.

Keywords

Pressure injury pain intensity Urgotul Absorb non-border foam dressing efficacy of wound dressings clinical effect

1. Introduction

The National Pressure Injury Advisory Panel (NPIAP) defines pressure injury (PI) as a local injury of skin and/or soft tissue located at the bone caused by medical or other equipment [1]. PI is common in long-term bedridden patients and is usually related to medical procedures or medical devices [2, 3, 4]. In addition to long-term bedridden patients, long-term wheelchair patients may also suffer from stress injury [5, 6]. Because of the high incidence rate and serious complications [3], PI affects the prognosis of patients. It not only increases the burden of treatment and nursing, but also reduces the quality of life of patients [7].

According to the severity of PI, it is divided into four stages: in Stage I the skin is intact and there is non-bleachable erythema locally; in Stage II part of the thickness of the skin is lost with exposed dermis; in Stage III there is full-thickness skin loss; and in Stage IV there is loss of full-thickness skin and tissue, with visible fascia/muscle/tendon/ligament/cartilage and bone. In addition, unstageable PI refers to the loss of full-thickness skin and tissue, which is covered by molting or eschar, so the severity of the injury cannot be determined. Deep tissue PI is characterized by persistent, non-bleachable deep red, maroon, purple discoloration or local injury with epidermal separation, showing dark wound bed or blood-filled blisters [1].

Deep tissue PI and stage 3 $\sim$ 4 PI can rapidly develop into an open ulcer, exposing the injured tissue to the external environment and leading to wound infection [8]. If not treated in time, it may endanger life. Because of its high risk and long recovery time, it is necessary to take measures that are more conducive to wound healing and promote the recovery of patients.

The main contents of PI treatment include reducing stress sources, fully draining any infected area, removing inactivated tissue and regular wound care to support the healing process [9]. In the treatment of PI, debridement and drainage of abscess must be carried out, and the combination of dressing can promote wound healing. In recent years, there are more and more studies on dressings for the treatment of PIs, and there is no unified conclusion on which dressing is the most effective [10]. Boyko’s research showed that the dressing should be selected according to the wound being treated [9]. In addition, Xu et al. studied a new LL-37 encapsulated chitosan hydrogel in the mouse model, which has biocompatibility and can promote the healing of pressure ulcer [8]. Silver has bactericidal properties [11]. Foam dressings are made of polyurethane (a semi permeable material) [12]. It has been found that silver containing dressings and foam dressings can be used for infectious PI, but foam dressings are usually used to prevent PI [13].

The purpose of this study is to evaluate the therapeutic effect of conservative sharps debridement combined with Urgotul Absorb non-border foam dressing on patients with deep tissue PI and stage 3 $\sim$ 4 PI, and to provide more references for the application of the new Urgotul Absorb non-border foam dressing in clinical treatment.

2. Data and methods

2.1 Research data

A total of 38 patients with stage 3 $\sim$ 4 PI and deep tissue PI admitted to Jinan Central Hospital from January 2016 to December 2018 were selected and randomly divided into two groups of 19 cases each, which were treated with silver ion cream dressing and Urgotul Absorb non-border foam dressing combined with SSD lipido-colloid gauze, respectively, with informed consent of the patients and reviewed and approved by the medical ethics committee of the hospital.

Inclusion criteria: (1) patients judged to suffer from stage 3 $\sim$ 4 pressure injuries and deep tissue pressure injuries according to the NPIAP definition and staging criteria [14]; (2) age $>$ 18 years; (3) wound extent $\geqslant$ 9 cm ${}^{2}$ ; (4) understanding of the clinical protocol and voluntary participation.

Exclusion criteria: (1) multi-organ failure and unable to maintain tolerance to debridement and dressing change for more than 3 weeks; (2) unable to cooperate with the experimental procedure; (3) wound area less than 9 cm ${}^{2}$ ; (4) insufficient clinical data.

2.2 Research methods

In this study, the standard control method was used.

Basic treatment: Thorough debridement, anti-infection according to drug sensitivity, nutritional support and PI prevention care.

Control group: On the basic treatment, silver ion cream dressing was used and the wound was routinely disinfected and changed once every 1 $\sim$ 2 days.

Observation group: On the basic treatment, for deep tissue PI without obvious purulent secretion and necrotic tissue or only skin color change, Urgotul Absorb non-border foam dressing could be directly applied; if the wound was seriously infected with more exudate and necrotic tissue was difficult to remove, then SSD lipido-colloid gauze could be applied internally and Urgotul Absorb non-border foam dressing could be applied externally, and the dressing was changed twice a week on average.

2.3 Observed indicators

Patients were observed for pain intensity during dressing changes and 4-week evaluation of PI wound treatment efficacy. Pain intensity during dressing changes: Because of the large number of elderly people with low literacy levels, a full-time trained nurse evaluated the pain level of patients by referring to the Wong-Banker Facial Expression Scale (FPS-R), which uses six facial expressions (pictures from smiling, sadness to crying with pain) to express the pain level, and the scores best representing categories of pain for the FPS-R were as follows: 0: no pain; 2: slight pain; 4: mild pain; 6: moderate pain; 8: severe pain; 10: horrible pain [15]. Measure the wound area and granulation tissue area with the Greatest Length and Width method (measure the maximum length from side to side and the maximum width perpendicular to the longest diameter of the wound, and multiply the length and width to obtain the estimated area of the wound). Then calculate granulation tissue coverage(granulation tissue area/wound area $\times$ 100%). The 4-week wound treatment efficacy was evaluated by an intermediate-level or higher surgeon. Cured: the wound was completely healed with no skin exudate; markedly effective: the necrotic tissue was completely replaced by healthy red granulation tissue and the surface area was reduced by $>$ 50%; effective: the necrotic tissue was completely replaced by red granulation tissue and the surface area was reduced by $>$ 10%; ineffective: most of the necrotic tissue was still present and the deep tissue damage deepened in color and turned into a non-stageable PI [16].

2.4 Statistical methods

The data were statistically analyzed using SPSS 19.0 software, and the measurement data were expressed as $\bar{x}\pm s$ , and the $t$ -test was used to compare the differences in measurement data, and the count data were expressed as percentage or composition ratio. $\chi^{2}$ test was used to analyze the differences in count data, and the rank sum test was used to analyze the differences in rank data. $P<$ 0.05 indicated that differences were statistically significant.

3. Results

3.1 General conditions of patients in both groups

There were no statistically significant differences in the demographic or clinical characteristics of the two groups, such as gender, age, and single wound area, and the two groups were comparable, as shown in Table 1.

Table 1
General conditions of patients in both groups

	Control group	Observation group	$X2/t$	$p$
Gender			0.110	0.740
Male	8	7
Female	11	12
Age	77.53 $\pm$ 9.01	72.14 $\pm$ 10. 15	1.551	0.130
Consultation departments			0.234	0.972
Respiratory	3	3
Nephrology	3	4
Neurology	6	5
Health care	7	7
Wound size (cm)			0.134	0.935
$\sim$	6	5
30 $\sim$	11	12
100 $\sim$	2	2
Stage			0.110	0.740
3	12	11
4	7	8
With or without wound undermining			0.128	0.721
With	5	6
Without	14	13
Deep tissue pressure injury
With	6	5	0.128	0.721
Without	13	14
Systemic antibiotic therapy			0.000	1.000
$\leqslant$ 5 d	13	13
$>$ 5 d	6	6

3.2 Comparison of pain scores during drug changes between the two groups

Among the 19 cases in the control group, there were 1 case of pain score 0, 3 cases of score 2, 5 cases of score 4, 6 cases of score 6, and 4 cases of score 8; there were 4 cases of score 0, 9 cases of score 2, and 6 cases of score 4 in the observation group, and the pain score in the observation group (2.21 $\pm$ 1.43) was lower than that in the control group (4.95 $\pm$ 1.19), and the difference was statistically significant ( $P=$ 0.000), as detailed in Table 2.

Table 2
Treatment and prognosis of patients in both groups

	Control group	Observation group	$t/Z$	$P$
Total number of dressing changes (times)	18.94 $\pm$ 13.66	7.73 $\pm$ 3.39	4.140	0.000
Wound area	57.12 $\pm$ 4.19	49.04 $\pm$ 6.21		0.000
Rate of granulation tissue coverage	61.22 $\pm$ 5.81	69.14 $\pm$ 6.02		0.000
4-week evaluation			$-$ 2.965	0.003
Cured	0	3
Markedly effective	3	10
Effective	8	6
Ineffective	8	0
Pain score	4.95 $\pm$ 1.19	2.21 $\pm$ 1.43		0.000

3.3 Comparison of treatment results between two groups of patients

The total number of dressing changes in the observation group (7.73 $\pm$ 3.39 times) was lower than that in the control group (18.94 $\pm$ 13.66 times), and the difference was statistically significant ( $P=$ 0.000). The wound area of the control group and the observation group were 57.12 $\pm$ 4.19 and 49.04 $\pm$ 6.21, and the granulation tissue coverage rate were 61.22 $\pm$ 5.81 and 69.14 $\pm$ 6.02, respectively, the difference was statistically significant ( $P=$ 0.000). In the observation group, there were 3 cured cases, 10 markedly effective cases, 6 effective cases, with a total effective rate of 100.00%; in the control group, there were 0 cured case, 3 markedly effective cases, 8 effective cases, 8 ineffective cases, with a total effective rate of 57.90%. The rank sum test was used to analyze the difference in rank data, and the efficiency of the observation group was higher than that of the control group ( $P=$ 0.003), see Table 2.

4. Discussion

PI is a disease that needs to be focused on in clinical care. In recent years, negative pressure wound therapy, moist therapy, and new dressings have been applied to clinical work, bringing a breakthrough in the treatment and care of PI [17]. With the aging of the population, the incidence of PI is still high as more prolonged bedridden patients suffer from local blood circulation disorders due to local tissue pressure, which causes inadequate supply of nutrients [18]. Among them, stage 3 $\sim$ 4 deep tissue pressure injuries have a long healing time, and indicators such as wound area and volume are commonly used to evaluate the treatment effect [19].

The new dressing Urgotul Absorb non-border foam is a wet healing dressing, which is characterized by preventing scab formation, not adhering to the new granulation tissue, painless replacement, favoring the dissolution of fibrin and necrotic tissue, creating a hypoxic environment to promote capillary angiogenesis, promoting the release and activity of a variety of growth factors, relieving wound pain and reducing scar formation, etc. Deep and narrow undermining with gauze silver filling can be removed in its entirety to avoid being left in the wound during dressing change, which can also effectively control infection and drainage. Silver ions are characterized by high efficiency, wide antibacterial spectrum, long-lasting antibacterial, and less susceptibility to drug resistance, but has a certain toxicity to the skin and mucous membrane [20].

The results of this study showed that the therapeutic efficiency of Urgotul Absorb non-border foam dressing was 100%, which was significantly higher than that of the control group. The moist healing theory [21] proposed that wound healing in a moist environment is one time faster than in a dry environment, and Urgotul can provide a moist environment for the wound and promote new tissue growth at the injury site. Compared with traditional dressings, the infection rate of using Urgotul dressing is lower for the following reasons: (1) it has good airtightness and is isolated from the outside world; (2) its ability to absorb exudate is stronger than gauze and can be absorbed vertically, which prolongs the time for dressing change and reduces the number of changes; (3) the moist, slightly acidic environment is conducive to the role of neutrophils, which enhances the local bactericidal ability and reduces the incidence of infection; (4) there is a lipido-colloid layer on the surface of Urgotul foam dressing, which can effectively play the role of autolytic debridement, and can penetrate into deep tissues to make the already purplish red or brown tissues gradually turn back into red or pink granulation tissues, and promote the healing of wound; (5) If the wound is severely infected with more exudate and necrotic tissue is not suitable for removal, internal application of SSD lipido-colloid oil gauze (i.e. silver ion oil gauze) should be performed.

Externally applied Urgotul dressing belongs to foam type dressing with obvious superiority in mechanical factors and exudate absorption, which can relieve the pressure of dressing on skin and tissues, ensure adequate blood perfusion to promote tissue renewal, rapidly absorb exudate to avoid bacterial growth causing infection, and its waterproof effect maintains a suitable local skin microenvironment [22]. In addition, foam dressing has the advantages of non-adherent wound contact, easy to change, and low irritation, and Urgotul foam dressing can also increase the comfort of patients [23].

The results of this study showed that the pain scores of patients in the observation group (2.21 $\pm$ 1.43) were lower than those of the control group (4.95 $\pm$ 1.19), indicating that the function of Urgotul dressing in dissolving fibrin and necrotic tissue reduces the times of dressing change, and it does not adhere to new granulation tissue and damage new or existing tissues during dressing changes, which facilitates the reduction of wounds, reduces patients’ pain during each dressing change, and improves patient acceptability and satisfaction. At the same time, reducing the number of dressing changes prevents wound enlargement, and the subjective feelings of patients with invasive injuries are to some extent related to the degree of patient cooperation, which in turn affects the therapeutic effect [24]. In the future, there was much work to be done. It was very important to guarantee the appropriate quality, performance and safety of medical products [25]. It was necessary of introduce metrology into medicine and defining standard regulations for inspections of medical devices [26]. Diversity and innovativeness of medical devices significantly contribute to improvement in quality and efficiency of healthcare services [27]. In future work, accurate relevant data on the use of dressings should be recorded to ensure traceability and support the assessment of product quality. In addition, it is also important for professionals to understand the performance of the equipment. In order to ensure the continued safe-use of a device for the manufacturer’s intended purpose these professionals must know how to use it, have means to identify when it is not used correctly or when it no longer works at manufacturer’s defined parameters [28]. Although when medical devices are concerned, AI is still in its beginnings, by introducing machine learning algorithms in medical devices management strategies benefit healthcare institution firstly in terms of increase of safety and quality of patient diagnosis and treatments, but also in cost optimization and resource management [29, 30].

This study has some limitations. Too small sample size may lead to deviation of statistical results. Inconsistent dressing change frequency due to dressing and patient’s condition characteristics may affect the experimental results.

5. Conclusion

The results of this study showed that the pain intensity during dressing change was significantly lower when applying Urgotul foam dressing for stage 3 $\sim$ 4 PI and deep tissue PI than that of traditional dressing change. It can significantly shorten the dressing change time, reduce the number of dressing changes, reduce patients’ pain, and improve patients’ comfort in dressing changes, thus enhancing the satisfaction of patients and their families, which is worth to be widely promoted.

Ethics statement

This study was conducted in accordance with the Declaration of Helsinki and approved by the ethics committee of Jinan Center Hospital of Shandong First Medical University.

Availability of data and materials

All data generated or analyzed during this study are included in this published article.

Funding

Not applicable.

Author contributions

Zhang MM conceived the study, Du HX and Ma XX participated in its design and coordination, and Zhao WX helped draft the manuscript. All authors read and approved the final manuscript.

Footnotes

Acknowledgments

Not applicable.

Conflict of interest

None of the authors have any personal, financial, commercial, or academic conflicts of interest.

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Effect evaluation of new dressing URGOTULRANGE in the treatment of pressure injury

Abstract

BACKGROUND:

OBJECTIVE:

METHODS:

RESULTS:

CONCLUSION:

Keywords

1. Introduction

2. Data and methods

2.1 Research data

2.2 Research methods

2.3 Observed indicators

2.4 Statistical methods

3. Results

3.1 General conditions of patients in both groups

Table 1 General conditions of patients in both groups

Table 2 Treatment and prognosis of patients in both groups

4. Discussion

5. Conclusion

Ethics statement

Availability of data and materials

Funding

Author contributions

Footnotes

Acknowledgments

Conflict of interest

References

Table 1
General conditions of patients in both groups

Table 2
Treatment and prognosis of patients in both groups