|Year : 2022 | Volume
| Issue : 1 | Page : 71-75
Prognostic factors related to delayed healing in venous leg ulcers treated with four-layer compression bandaging: A prospective observational study on a cohort of patients
Sasidharan Vineeth1, Sanju Samuel1, Anoop Vasudevan Pillai1, Riju Ramachandran1, Renjitha Bhaskaran2
1 Department General Surgery, Amrita Institute of Medical Sciences, Kochi, Kerala, India
2 Department of Biostatistics, Amrita Institute of Medical Sciences, Kochi, Kerala, India
|Date of Submission||09-Feb-2022|
|Date of Decision||11-May-2022|
|Date of Acceptance||12-May-2022|
|Date of Web Publication||14-Jul-2022|
Dr. Riju Ramachandran
AG-1, Sterling Sarovar, Kosseri Lane, Edapally, Kochi, Kerala
Source of Support: None, Conflict of Interest: None
Background: Four-layer compression bandage is found to be very effective in healing most venous ulcers. Various causes have been suggested in the literature for delay in healing despite compression. However, Indian literature on venous ulcers, compression bandage and prognostic factors for healing of venous leg ulcers (VLUs) are lacking. This study was a prospective observational study on a cohort of patients with VLU treated with four-layer compression bandage, to assess prognostic factors causing delay in the healing process. Subjects and Methods: After obtaining approval from the institutional review board, all patients with VLUs treated using four-layer compression bandage in the department of general surgery from October 2018 to October 2020 were included in the study. Age, gender, body mass index (BMI), waist–hip ratio, duplex/Doppler findings, culture and sensitivity report of swab taken at the time of first visit and ulcer healing time were recorded. To test the significant association of categorical variables between groups, Chi-square test with continuity correction was applied. Results: There were 150 patients included in the study. Ulcer healed completely in 101 patients, and there was delay/non-healing in 49 (32.7%) patients. Ulcer was more common in male patients and those above 45 years of age (mean age: 57.0200 ± 8.86 years). Female gender had a better prognosis. BMI > 25 (P = 0.04); infection with Pseudomonas (P = 0.001), staphylococci (P = 0.001) and Klebsiella and saphenopopliteal junction (SPJ) incompetence (P = 0.001) adversely affected healing of VLUs. Conclusion: Compression bandage significantly improves wound healing in VLUs. Female gender, obesity, SPJ incompetence and secondary infections are independent risk factors for delayed healing in VLUs.
Keywords: Chronic venous insufficiency, compression bandage, ulcer, wound healing
|How to cite this article:|
Vineeth S, Samuel S, Pillai AV, Ramachandran R, Bhaskaran R. Prognostic factors related to delayed healing in venous leg ulcers treated with four-layer compression bandaging: A prospective observational study on a cohort of patients. Kerala Surg J 2022;28:71-5
|How to cite this URL:|
Vineeth S, Samuel S, Pillai AV, Ramachandran R, Bhaskaran R. Prognostic factors related to delayed healing in venous leg ulcers treated with four-layer compression bandaging: A prospective observational study on a cohort of patients. Kerala Surg J [serial online] 2022 [cited 2022 Sep 24];28:71-5. Available from: http://www.keralasurgj.com/text.asp?2022/28/1/71/350903
| Introduction|| |
Venous disorders of the lower limb are a spectrum of symptoms and signs ranging from visibly enlarged veins in the limb to ulcer. Most patients have no symptoms or only visible veins, but occasional patients have disease progression leading to skin change, oedema and ulceration (CEAP class C3–C6). This unfortunate set of symptoms and signs due to the progression of disease is the chronic venous insufficiency (CVI). Venous leg ulcers (VLUs) are the end-stage complication of CVI and are classically described over the gaiter region.
The prevalence of VLUs is between 0.12% and 1.7% and increases with age with a prevalence of more than 4% in patients over 65 years of age., Compression garments or bandages have been the mainstay of treatment and are considered the gold standard in healing of venous ulcers. Endovenous procedures or Trendelenburg operation is recommended for these patients to prevent a recurrent ulceration and in some patients in the treatment of recalcitrant ulcers. Most VLUs heal within 3–6 weeks of starting compression therapy. However, it is common to find patients who take a longer time (>3–6 months) to heal. The objective of our study was to assess the prognostic factors that delay healing in a cohort of patients with VLU treated with four-layer compression bandage.
| Subjects and Methods|| |
This is a prospective observational study on a cohort of patients with venous ulcer treated at a tertiary referral centre with four-layer compression bandage from October 2018 to October 2020. Patients who were registered and treated at the general surgery department for venous ulcers were included in the study. All patients with ulcer confirmed to be due to venous aetiology were included in the study. The institutional ethical committee clearance was obtained before enrolment of patients into our study (IRB-AIMS-2018-264).
Based on the proportion of delayed healing in patients treated with four-layer compression bandage observed in an earlier publication with 95% confidence and 20% allowable error, the minimum sample size comes to 140.
All the patients were serially followed up from the time of first visit to the general surgery outpatient department till the time of ulcer healing (~90 days). Clinical assessment included a detailed history and physical examination of the patient with leg ulcer. Four-layer compression bandaging was done for all patients with VLU who were included in the study. Patients were reviewed once a week for reinspection of the ulcer and revision of the four-layer bandage.
Venous Doppler study of the lower limbs was done for all patients to assess the competence of valves in superficial and deep veins of the lower limb, especially at saphenofemoral junction (SFJ), saphenopopliteal junction (SPJ), perforators and deep veins. Deep vein obstruction was also ruled out. Patients with diabetic foot, neuropathic ulcers, arterial ulcers, traumatic ulcers and ulcers due to malignancy were excluded from the study. Body mass index (BMI) and waist–hip ratio (WHR) were calculated and recorded for all the patients included in the study. BMI was calculated using the formula BMI = weight in kg/height in m2. BMI of more than 25 was considered to be overweight and BMI of 18–25 was considered to be normal. The WHR was calculated as waist circumference in centimetres divided by hip circumference in centimetres (W/H) indicating obesity. WHR >0.90 was considered to be overweight in males and WHR >0.80 was considered to be overweight in females.
Culture swabs were taken in all patients by the Levine technique. The wound was considered to be infected if there were any microorganisms cultured in the sample. Antibiotics were started based on culture and sensitivity. The culture was repeated after 2 weeks to confirm the sterile wound environment.
Four-layer compression bandage was applied once a week for all patients by doctors or staff who were specially trained. Overhead projector sheet and graph paper were used for the assessment of wound healing by measuring the surface area of ulcer at presentation and then every week till 12th week (90 days). The number of patients with ulcers that healed completely by 12 weeks was noted. If the ulcer had not healed by 12 weeks, it was considered a 'non-healing ulcer'.
The primary aim of our study was to estimate the incidence of delayed healing amongst patients with VLU treated using four-layer compression bandage and the secondary aim was to evaluate the prognostic factors including microbiological profile in delayed healing of VLUs.
Statistical analysis was performed using IBM SPSS Statistics for Windows, version 20.0 (IBM Corp., Armonk, NY, USA). Categorical variables were expressed using frequency and percentage. Continuous variables were presented using mean and standard deviation. To test the statistically significant mean comparison between the groups, Student's t-test was applied. To test the significant association of categorical variables between groups, Chi-square test with continuity correction was applied. P < 0.05 was considered statistically significant.
| Results|| |
Our study included 150 patients who presented with VLUs which included 84 males (56%) and 66 females. The mean age of our study population was 57.0200 ± 8.86 years (37–75 years). In our series, ulcer was more common and the mean size of the ulcer was bigger (9.4 ± 2.5 cm vs. 8.4 ± 2.5 cm) in patients above 45 years of age (n = 133) [Table 1]. The ulcer healed completely in 101 patients (67%) within 12 weeks. One-third of our patients (32.7%) had delayed healing of VLUs despite the application of compression bandage. There was a statistically significant (P < 0.003) faster healing of venous ulcers in females with VLUs [Table 2]. Patients who were overweight had a significantly increased chance of delayed healing of VLUs (P < 0.004) [Table 3]. However, WHR was not a significant prognostic factor in delayed healing of VLUs in both males and females [Table 3].
|Table 3: Relationship of body mass index and waist–hip ratio to healing status|
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There were 207 organisms isolated in the cultures taken from 79 patients having infected venous ulcers. Pseudomonas aeruginosa was cultured in 33.3% of the samples, followed by Staphylococcus and Klebsiella species in 32.7%. Other bacterial isolates are shown in [Table 4]. There was a significant delay in healing with VLUs infected by P. aeruginosa, Staphylococcus aureus, Streptococcus species and Klebsiella [Table 4].
On analysis of duplex results of patients, patients with SFJ incompetence and perforator incompetence constituted a large bulk of the study population with VLUs (n = 125). There were only four patients in our series with deep vein incompetence. When healing rates were compared for patients having SFJ incompetence alone, SFJ + perforator incompetence, perforator incompetence alone and deep vein incompetence, the values did not achieve statistical significance, indicating that incompetence in these areas has no major prognostic significance in delayed healing of VLUs treated with compression bandage. We found that 35 patients had SPJ incompetence either in isolation or along with other valvular incompetence in our series. Only 2 of these 35 patients had complete healing of the wound at 12 weeks [Table 2]. SPJ incompetence in patients with VLUs significantly delays wound healing (P = 0.001).
| Discussion|| |
CVI is a common cause for leg ulcers., VLUs are the end stage of the disease process and cause significant morbidity and economic burden to the patient. The ulcers are difficult to heal and often require prolonged management in specialised centres for superior results. The standard of care for the management of VLUs is compression bandaging. Bisgaard's regimen has been a popular conservative method in venous ulcer management but is time-consuming and gives equivocal results. Early operative intervention is now advocated in recalcitrant ulcers.
VLUs occur due to ambulatory venous hypertension with stasis of blood resulting in accumulation of senescent fibroblasts, inhibition of growth factors and increased activity of matrix metalloproteinases. Four-layer compression bandaging reduces ambulatory venous hypertension and hence plays a significant role in the treatment of VLUs. Compression therapy also accelerates wound healing and prevents recurrence. Although it provides high rates of healing, there are still ulcers that are refractory to four-layer bandaging. VLUs usually heal by 3 weeks–3 months using compression therapy. Despite compression bandage, a considerable proportion of patients have delayed or non-healing. Prognostic factors for poor healing despite compression bandage in VLUs have not been extensively described in Indian literature. Several factors affecting healing of normal wounds have been described in the literature and these may also affect healing of VLUs.
In our study, out of 150 patients treated with four-layer compression bandage, 32.7% of patients had delayed healing. Patients over 45 years of age had large ulcers with delayed healing. Although international studies describe VLUs to be common in women, Indian studies have suggested a male predominance., A meta-analysis of patients with VLUs has shown no gender difference in healing of VLUs. However, in our study, we found that female patients had a significantly early and increased rate of healing.
Obesity prolongs the healing time of VLUs and is an indicator of poor healing. Immobility of patients and inactivity of calf muscle pump are thought to be the reasons for poor healing in obesity. Most studies showed that BMI and WHR are prognostic factors in delayed wound healing. In our study, increased BMI alone was a significant prognostic factor for delayed wound healing. WHR had no effect in delayed wound healing in VLUs.
Most studies confirmed that infection by bacteria is an important prognostic factor in delayed wound healing. However, the role of these bacteria in the pathogenesis in the VLU is unclear. There are very few reports on individual bacteria and their effect on the healing of VLUs. We attempted to correlate bacterial infections and the effect of individual bacteria on healing. In our study, infection of VLU with Pseudomonas, S. aureus, Klebsiella and streptococci showed a statistically significant delay in healing of VLU. These were the commonly isolated bacteria in our cultures. Other bacteria were rare and did not show a statistically significant change in the healing of VLU. The presence of P. aeruginosa can retard the healing of wounds due to their ability to form biofilms.
Superficial venous insufficiency is the most common cause of VLUs. Incompetency of the valves of the truncal veins has a better prognosis than incompetence of truncal veins along with perforators. Deep venous incompetence though rare is also implicated as a cause for VLU. Forty to fifty per cent of venous ulcers are due to superficial venous insufficiency and perforating vein incompetence alone with a normal deep venous system. However, many studies have proven that venous ulcer healing after four-layer compression bandaging is not influenced by the pattern of venous incompetence. The role of incompetent SF junction in the pathophysiology of CVI has been described in many studies. Ablation of the long saphenous vein or disconnection at the SFJ has given an excellent result in healing VLUs. SPJ also has similar pathophysiological implications. The relative risk of the superficial venous system versus perforator system versus deep venous system in the cause of VLUs has also been described in detail. However, individual major valves (SFJ and SPJ) and their relative risk as prognosticators for VLU healing have not been described. Twenty per cent of our patients had SPJ incompetence; only two of these patients had early ulcer healing, indicating that reflux at SPJ has poor prognosis in VLU healing. Popliteal vein incompetence as an indicator of poor response to compression therapy in VLU has also been reported in a study done by the Royal Infirmary, Edinburgh. In our set of patients, only SPJ incompetence had a statistically significant association with poor healing of VLU using compression bandaging. All the other patterns of venous insufficiency showed no statistical correlation as causes of delayed healing of VLUs.
| Conclusion|| |
Four-layer bandage offers a good option for effective wound healing in VLUs. Males are more commonly afflicted with disease progression and venous ulceration in the Indian population. Age below 45 years and female gender are favourable prognostic factors for early wound healing in VLUs. Obesity and SPJ incompetence are independent risk factors for delayed healing in VLUs. Secondary infections by Pseudomonas and Staphylococcus are also adverse prognostic factors in wound healing due to the formation of biofilm. Identification of risk factors and their correction helps in the early healing of VLUs.
We would like to thank staff of the department of general surgery who were constantly helping us in the management of these patients.
Financial support and sponsorship
This study was financially supported by the Amrita Institute of Medical Sciences.
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4]