|Year : 2019 | Volume
| Issue : 4 | Page : 194-198
The influence of compression strength and patient and wound variables on venous leg ulcers healing
Vesna Karanikolic1, Masa Golubovic1, Goran Stevanovic2, Irena Jankovic2, Aleksandar Karanikolic1
1 Medical Faculty Nis, Clinic for Skin Diseases of the Clinical Center Nis, Serbia
2 Medical Faculty Nis, Clinic for Skin Diseases of the Clinical Center Nis; Clinic for Plastic Surgery of the Clinical Center, Nis, Serbia
|Date of Submission||09-Nov-2018|
|Date of Decision||30-Dec-2018|
|Date of Acceptance||22-Apr-2019|
|Date of Web Publication||31-Oct-2019|
Dr. Vesna Karanikolic
Medical Faculty Nis, Clinic for Skin Diseases of the Clinical Center Nis, Serbia, Bul. Dr Zorana Djindjica 48 18000 Nis
Source of Support: None, Conflict of Interest: None
Background: Venous leg ulcers (VLUs) constitute a worldwide public health problem and have a significant impact on patient quality of life. The treatment is complex, with high failure rates. Objectives: The objective was to identify the influence of compression strength and patient and wound variables on VLUs healing. Methods: A total of 102 patients were supervised for 48 weeks since the commencement of the treatment. The patients were divided into two groups according to two different compression systems, one group with moderate compression pressure of 35–40 mmHg and the second with high pressure >45 mmHg. Results: Deep venous reflux, dermatitis, ulcer infection, duration of the ulcer, and the ulcer size (US) are statistically significantly lower (P < 0.001) in patients with healed wounds. These factors have also shown statistical significance related to prolonged healing time. Patients with VLU in which high pressure was applied, healed considerably faster in relation to VLU in which moderate pressure was applied (P = 0.008). Conclusion: Deep venous reflux, dermatitis, ulcer infection, duration of the ulcer, and the US were independently correlated with worse healing rates. Higher compression pressure leads to faster and higher proportions of VLUs healed. The authors recommended a holistic approach to wound healing with careful and individualized assessment of risk factors among patients with VLUs.
Keywords: Compression, leg ulcer, lower extremity, risk factors, wound healing
|How to cite this article:|
Karanikolic V, Golubovic M, Stevanovic G, Jankovic I, Karanikolic A. The influence of compression strength and patient and wound variables on venous leg ulcers healing. Dermatol Sin 2019;37:194-8
|How to cite this URL:|
Karanikolic V, Golubovic M, Stevanovic G, Jankovic I, Karanikolic A. The influence of compression strength and patient and wound variables on venous leg ulcers healing. Dermatol Sin [serial online] 2019 [cited 2020 Mar 31];37:194-8. Available from: http://www.dermsinica.org/text.asp?2019/37/4/194/270158
| Introduction|| |
Venous leg ulcers (VLUs) constitute a worldwide public health problem and have a significant impact on patient quality of life. The treatment is complex, with high failure rates. They are the major cause of chronic wounds, occurring in 70%–90% of leg ulcer cases. Venous ulcers develop mostly along the medial distal leg and can be very painful with significant effects on the quality of life. Published healing rates of VLUs obtained with compression therapy vary widely and could range between 40% and 95%.,
Risk factors for delayed VLU healing can be categorized into three main groups: those related to the ulcer, those related to the patient, and those related to the wound treatment. The identification of risk factors that predispose these patients to prolonged wound healing not only offers an opportunity to determine their clinical outcome but can also be linked to the decision regarding alternative interventions or even reorganization of the wound treatment.
The purpose of this study was to identify the influence of compression strength and patient and wound variables on VLUs healing.
| Methods|| |
The study included 102 outpatients, over the age of 18 years, with existing venous ulcers treated at the Clinic for Skin Diseases of the Clinical Center Nis. The patients were supervised for 48 weeks since the commencement of the treatment.
A color duplex scan of the leg blood vessels was performed, and ankle–brachial pressure index (ABPI) was established in all patients. The direction of the flow was evaluated in a 20°–30° reverse Trendelenburg position during the Valsalva maneuver. A cuff inflation–deflation method with rapid cuff deflation in the standing position has been performed to induce reflux. A significant flow to the feet was indicative of reflux. A reflux time of > 0.5 s was used to diagnose the presence of the reflux. Reflux was categorized into three groups: presence of superficial reflux only; additional presence of one or more insufficient perforating calf veins, without deep venous reflux, and the presence of deep venous reflux at any level of the crurofemoral axis, with or without varicose veins.
This study comprised patients with venous ulcers over 3 cm2 and the duration of illness longer than 3 months. Patients with ABPI < 0.8, with existing cardiac insufficiency (ejection fraction <35), pregnant women, patients with malignant diseases, patients at immunosuppressive, and cortical therapy were excluded from the study. Further, patients who have VLU associated with skin vasculitis, pyoderma gangrenosum, and other neutrophilic dermatoses or bilateral VLU were excluded from this study.
Overall, 123 patients were evaluated for eligibility. We excluded 14 patients (not meeting inclusion criteria n = 8, declined to participate n = 5, and other reason n = 1). One hundred and nine patients were randomized. On randomization, three patients declined to participate at the beginning of the study, three patients declined to participate during the study, and one patient did not follow-up (due to relocation). Thus, 102 patients were analyzed.
The study used patients' data such as age, gender, history of deep vein thrombosis (DVT), prior episodes of ulceration, previous operation on the veins, body mass index, calf circumference (CC), number of ulcerations, ulceration localization, ulcer size (US), duration of the ulcer, and healing rate. The study also included data regarding dermatitis, lipodermatosclerosis, and ulcer infection as locoregional characteristics of ulcerations. The determination of the dimensions of ulceration was performed by evaluating the maximum width and length of the ulceration, as well as using the computerized process consisting of mapping the two-dimensional digital image onto the polygonal mesh. The calf and ankle circumference were measured in the recumbent position with the maximal (calf) and minimal (ankle) point determined visually. The definition of ulcer closure was the point at which complete epithelialization of the reference limb occurred.
The study was approved by the Institutional Review Board of Clinical Center Nis (IRB No. 2015-05-07) and all patients in this study had written the informed consent. Randomization was computer generated. The patients were divided into two groups according to two different compression systems. The first group consisted of patients treated with compression Class III therapy with compression pressure of 35–40 mmHg (moderate pressure), whereas the second group was composed of patients who had an elastic bandage added to the compressive agents of Class III. The compressive pressure in these patients was >45 mmHg (high pressure).
The local ulceration treatment involved the use of local antiseptics and antibiotics. The standard regime included wound debridement. Absorbent dressings were applied to the wet wounds. Based on the amount of the exudate, the linings were changed between 1 and 7 days. After debridement and rewinding of the ulceration, the bandaging systems were applied. The first and second layers included gauze without pressure. For the third layer in the first group, a tubular compression system tubulus (tubular, knitted, ready-made device, with the device size determined for each patient according to the circumferences of the leg measured at the ankle, and the largest part of the calf; S, M, L, XL, and XXL sizes was available) was used. For patients in the second group, the additional elastic bandage was applied over the Tubulcus. The elastic bandages were applied in a spiral with a 50% overlap with the patient in the recumbent position and the foot in the dorsal flexion. The bandages were characterized as long stretch (200% stretch). The applied elastic bandage was renewed after 2 and 4 months and cleaned in between. The compressive system was applied by the patient every morning, and the bandages were removed overnight. After VLU healing, patients were advised to continue the use of Tubulcus to prevent a recurrence.
The data are presented in the form of an arithmetic mean ± standard deviation, by the way of absolute and relative numbers. Continuous variables were compared with a test or Mann–Whitney test. Categorical variables were compared with the Chi-square test. Testing of the potential risk factors for wound healing was performed by means of multivariate logistic regression analysis. The Hosmer–Lemeshow test was used to test the calibration of the multivariate model. The Kaplan–Meier curve was applied to estimate the rate of wound healing in relation to pressure values. Cox regression analysis was utilized to estimate potential healer predictors. The hypothesis was tested with a significance threshold P < 0.05. Data were analyzed using R software (Version 2.15.2, Tubulcus; Laboratoires Innothera, Arcueil, France). R core team (2012). R is a language and environment for statistical computing, Vienna, Austria. ISBN 3-900051-07-0, http://www.R-project.org/.
| Results|| |
The study involved 102 patients (46 males and 56 females). The average age of the study population was 63.0 ± 10.7 years (minimum 42 and maximum 85 years). The VLU healing was uniform in relation to sex (P = 0.955) and age (P = 0.419). The CC, the duration of the ulcer, and the size of the ulcer are statistically significantly lower in patients with healed wounds (P = 0.019, P = 0.009, and P < 0.001). The history of venous thrombosis is statistically significantly more frequent in patients without healing (67.9% vs. 32.4%, P = 0.003), as well as previous operations on veins (60.7% vs. 23.0%, P = 0.001). Group of patients with healed VLU was statistically significantly more likely to have one ulcer, and a group of patients not healed had two ulcerations (P < 0.001). Perforating vein incompetence was statistically more common in patients with not healed ulcers (85.7% vs. 48.6%, P = 0.002). Deep venous reflux, dermatitis, lipodermatosclerosis, and infection were statistically significantly more common in patients with ulcers not healed (P < 0.001, P < 0.001, P = 0.030, and P < 0.001) [Table 1]. The healing rate was statistically significantly larger in the group with a higher pressure applied compared to moderate pressure (P = 0.034).
|Table 1: Demographic and clinical characteristics of patients by outcome groups|
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As a result, it can be concluded that deep venous reflux, dermatitis, ulcer infection, duration of the ulcer, and the US are statistically significantly lower in patients with healed wounds.
Based on data analysis, risk factors for the failure of a VLU to heal in group with applied moderate pressure are a history of DVT (odds ratio [OR]:0.150, P = 0.009) and CC (OR: 0.155, P = 0.012). Risk factors on the failure of a VLU to heal in group with applied high pressure are dermatitis (OR: 0.880, P = 0.049) and deep venous reflux (OR: 0.075, P = 0.023) [Table 2].
|Table 2: Risk factors on the failure of a venous leg ulcer to heal in association with the subbandage pressure|
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Risk factors associated with prolonged healing time were history of DVT (Hazard ratio [HR]: 0.478, 95% confidence interval [CI]: 0.295–0.787, P = 0.004), previous operations (HR: 0.404, 95% CI: 0.234–0.698, P = 0.001), size of the ulcer (HR: 0.884, 95% CI: 0.846–0.924, P ≤ 0.001), CC (HR: 0.953, 95% CI: 0.918–0.989, P = 0.011), dermatitis (HR: 1.843, 95% CI: 1.159–2.932, P = 0.010), number of ulcer (HR: 0.063, 95% CI: 0.015–0.258, P < 0.001), superficial reflux only (HR: 4.071, 95% CI: 1.252–13.241, P = 0.020), perforating vein incompetence (HR: 0.359, 95% CI: 0.226–0.572, P < 0.001), deep venous reflux (HR: 0.229, 95% CI: 0.135–0.389, P ≤ 0.001), patients with dermatitis (HR: 0.337, 95% CI: 0.209–0.543, P < 0.001), lipodermatosclerosis (HR: 0.460, 95% CI: 0.292–0.752, P = 0.002), and infection (HR: 0.173, 95% CI: 0.104–0.289, P < 0.001) [Table 3].
|Table 3: Influence of the risk factors on the prolonged venous leg ulcer healing time (Cox regression analysis-univariate analysis)|
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Patients with VLU in which high pressure was applied healed considerably faster in relation to VLU in which moderate pressure was applied (P = 0.008) [Figure 1].
|Figure 1: Influence of the compression strength on venous leg ulcer healing time|
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| Discussion|| |
The aim of this study was to define the impact on compression strength and patient and wound variables on VLUs healing. A high rate of participant follow-up was achieved in this study.
The data obtained from the literature indicate the healing rates of venous ulcers treated with compression therapy is 40%–95%.,, However, it has been established that despite the use of compressive therapy, a significant number of VLUs remain refractory to treatment. Thus, it could be logically questioned whether it is necessary to determine the most important prognostic risk factors to predict nonhealing VLU.
A large number of studies concerned with identifying factors associated with delayed VLU healing have shown that US and ulcer duration were very significant prognostic parameters.,, Studies have indicated that deep vein involvement, age, and history of DVT are risk factors for slow VLU healing. However, studies of risk factor profiles have suggested that there may be a number of other factors related to ulcer healing including patients' sex, general mobility, ankle movement, venous surgery, ABPI <0.8, >50% of wound covered with fibrin, and hip / knee replacement surgery. Despite the clear correlation of these factors with delayed VLU healing, studies have shown the importance of other parameters as well as their interconnectedness.,,
Except for the prognostic factors related to the ulcer and related to the patient, socioeconomic factors (such as being single, being of a low social class, and having no access to central heating) play a significant role in VLU healing.,
Our study showed that CC, the duration of the ulcer, and the US were statistically significantly lower in patients with healed wounds (P = 0.019, P = 0.009, and P < 0.001, which is in agreement with the previous studies.,, The history of venous thrombosis is statistically significantly more frequent in patients without healing (P = 0.003), as well as previous operations on the veins (P = 0.001).
Our study showed that the healing rate was statistically significantly higher in the group with a higher pressure applied compared to moderate pressure (P = 0.034). Patients with VLU in which high pressure was applied healed considerably faster in relation to VLU in which moderate pressure was applied (P = 0.008).
A small number of studies dealt with the applied compression strength as a factor of VLU healing. Research has shown that a higher subbandage pressure (SBP) value leads to shorter healing time of VLU.,, A retrospective cohort study of patients with venous ulcers showed that compliance with compression therapy had a major beneficial effect on 6 months' healing. However, this study considered the application of various compression therapies (elastic stocking, elastic bandage, and Unna boot) rather than different levels of compression.
A randomized, open-prospective, single-center study was performed to determine the healing rates of VLU treated with different compression strength. The results of this study indicate that higher healing rate is achieved with high pressure, compared to moderate pressure, and that the compression system should be individually determined for each patient according to individual leg characteristics.
High compression bandages provide and maintain high levels of compression pressures at the ankle (range 25–35 mmHg). In more active patients and patients with bigger legs, high compression showed better results. A larger number of research has shown that high compression is preferred compared to the low compression in managing VLU.,,,
Studies have emphasized the fact that multilayering increases the stiffness of bandages, as well as SBP. A larger number of researches has shown that SBP of 30–40 mm Hg is recommended for successful healing of VLU. Multicomponent multilayer compression is superior to a single-component, single-layer compression bandage systems.
| Conclusion|| |
Based on the available literature review and results obtained from this study, deep venous reflux, dermatitis, ulcer infection, duration of the ulcer, and the US are statistically significantly lower in patients with healed wounds. These factors have also shown statistical significance related to prolonged healing time. Patients with VLU in which high pressure was applied healed considerably faster in relation to VLU in which moderate pressure was applied. Thus, the authors recommended a holistic approach to wound healing with careful, individualized assessment of risk factors among patients with VLUs.
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Conflicts of interest
There are no conflicts of interest
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[Table 1], [Table 2], [Table 3]