Four-layer Compression Bandaging Research Articles

Comparative Efficacy and Cost-Effectiveness of Two-Layer Versus Four-Layer Compression Bandages for Venous Leg Ulcers: A Prospective Study.

This study aims to evaluate and compare the efficacy and cost-effectiveness of two-layer versus four-layer compression bandages in the treatment of venous leg ulcers (VLUs). A prospective study was conducted at a tertiary hospital from August 2022 to July 2024. A total of 100 patients with chronic VLUs were sampled. Of the patients, 50 were given two-layer (group A) compression therapy, and the other 50were given four-layer (group B) compression therapy. Outcomes after both therapies were analyzed. The mean age of the participants was 45.76 years, with a predominance of males (67%). Both bandaging systems demonstrated similar healing efficacy with no significant difference in ulcer size or healing time between groups. However, the four-layer bandage system required significantly fewer follow-ups (mean = 4.88) compared to the two-layer system (mean = 6.46) (p < 0.001). The mean total cost was higher for the four-layer system (₹3416) compared to the two-layer system (₹2907) (p = 0.004). Complications such as pain and pressure ulcers were comparable, though the four-layer system was associated with slightly higher discomfort and skin irritation. The four-layer bandage system may offer marginal advantages in wound healing and fewer follow-ups, but it is more expensive. The two-layer bandage system is more cost-effective and patient-friendly.

Patients with venous leg ulcers can be managed safely in the community ----results of an observational comparison study in Singapore

AimTo examine the healing outcomes of patients with venous leg ulcers requiring compression bandaging in community care versus tertiary care. MethodThis was an analytical observational cohort study. Venous leg ulcer (VLU) patients who required compression bandaging were recruited from an outpatient vascular clinic between May 2021 and August 2022. Eligible patients received two—or four-layer compression bandaging and followed up with the community care or tertiary care centre nurses. The primary outcome was the difference in the total surface area of the VLU after 12 weeks, and the secondary outcome was the patient's quality of life, as measured by the Cardiff Wound Impact Schedule (CWIS). ResultsForty-seven VLU patients were recruited; 27 received compression bandaging in the community care and 20 by the tertiary care centre. Mean age 70 years old (SD 11.04). The two most prevalent comorbidities were hypertension (51.06 %) and diabetes mellitus (38.29 %). Among those who completed follow-up (12 weeks), the median difference of the total surface area of the VLU between community-based care (p = 0.02) versus tertiary-based care (0.003) was significant. However, there was no difference in the healing status between community and tertiary-based care (p = 0.68). There was no difference in the quality of life of patients between groups. ConclusionThis first tropical study comparing VLU healing outcomes between community and tertiary care found no significant difference in healing with compression bandaging by nurses in either setting. However, the small sample size and high dropout rate limit the generalizability of the findings, necessitating a larger-scale study with longer follow-up. Despite these limitations, the study is a crucial step toward improving wound care services in Singapore, and highlights the need for further research to guide future community wound care implementation.

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

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

Deep vein insufficiency and the results of four-layer compression bandages in the treatment of venous ulcers: A retrospective study

Deep vein insufficiency and the results of four-layer compression bandages in the treatment of venous ulcers: A retrospective study

The Effects of Four-layer Compression Bandages and Hyperbaric Oxygen Treatment on Lower Extremity Venous Ulcers

The Effects of Four-layer Compression Bandages and Hyperbaric Oxygen Treatment on Lower Extremity Venous Ulcers

How do four-layer compression bandages compare in people with venous leg ulcers?

How do four-layer compression bandages compare in people with venous leg ulcers?

Compression Stockings, Rather than Bandages, for Venous Leg Ulcers

Four-layer compression bandages have long been standard care for venous leg ulcers, but they are bulky and require frequent professional attention.

Stockings before bandages: an option for venous ulcers

In The Lancet, Rebecca Ashby and colleagues1 report the results of a large pragmatic trial of a treatment for venous leg ulcers, in which they compare new two-layer compression hosiery with four-layer compression bandages, which are regarded as the standard care for venous leg ulcers. The investigators recorded no difference in the number of patients healed, and no difference in the trial's primary endpoint, median time to healing, between the two treatment groups—99 days (95% CI 84–126) with hosiery and 98 days (85–112) with compression bandages.

Clinical and cost-effectiveness of compression hosiery versus compression bandages in treatment of venous leg ulcers (Venous leg Ulcer Study IV, VenUS IV): a randomised controlled trial

Drawbacks exist with the standard treatment (four-layer compression bandages) for venous leg ulcers. We have therefore compared the clinical effectiveness and cost-effectiveness of two-layer compression hosiery with the four-layer bandage for the treatment of such ulcers. We undertook this pragmatic, open, randomised controlled trial with two parallel groups in 34 centres in England and Northern Ireland. The centres were community nurse teams or services, family doctor practices, leg ulcer clinics, tissue viability clinics or services, and wound clinics. Participants were aged 18 years or older with a venous leg ulcer and an ankle brachial pressure index of at least 0·8, and were tolerant of high compression. We randomly allocated participants (1:1) to receive two-layer compression hosiery or a four-layer bandage, using a remote randomisation service and prevalidated computer randomisation program. Participants were stratified by ulcer duration and ulcer area with permuted blocks (block sizes four and six). The primary endpoint was time to ulcer healing, with a maximum follow-up of 12 months. Although participants and health-care providers were not masked to treatment allocation, the primary endpoint was measured by masked assessment of photographs. Primary analysis was intention to treat with Cox regression, with adjustment for ulcer area, ulcer duration, physical mobility, and centre. This trial is registered with the ISRCTN register, number ISRCTN49373072. We randomly allocated 457 participants to the two treatment groups: 230 to two-layer hosiery and 227 to the four-layer bandage, of whom 453 (230 hosiery and 223 bandage) contributed data for analysis. Median time to ulcer healing was 99 days (95% CI 84-126) in the hosiery group and 98 days (85-112) in the bandage group, and the proportion of ulcers healing was much the same in the two groups (70·9% hosiery and 70·4% bandage). More hosiery participants changed their allocated treatment (38·3% hosiery vs 27·0% bandage; p=0·02). 300 participants had 895 adverse events, of which 85 (9·5%) were classed as serious but unrelated to trial treatment. Two-layer compression hosiery is a viable alternative to the four-layer bandage-it is equally as effective at healing venous leg ulcers. However, a higher rate of treatment changes in participants in the hosiery group than in the bandage group suggests that hosiery might not be suitable for all patients. NIHR Health Technology Assessment programme (07/60/26).

Different context, different results: venous ulcer healing and the use of two high‐compression technologies

To update the evidence for the relative effectiveness of the four-layer and short-stretch compression technologies used for the treatment of venous ulcers. Compression bandages are the most effective method for venous ulcer healing. Both four-layer and short-stretch compression are effective but the relative benefit of one over the other is not fully understood. Meta-analysis of data from randomised trials of short-stretch and four-layer compression bandages. We conducted a hazards ratio meta-analysis that combined the results from the existing review evidence with the latest randomised trial. Prior to inclusion of the Canadian Bandaging Trial, the meta-analysis of the available evidence from four trials indicated that short-stretch bandaging was associated with a lower chance of healing than four-layer bandaging. Adding this trial to the meta-analysis however, the relative benefit for the four-layer bandaging did not persist. Addition of the largest trial of compression technologies attenuated the apparent relative benefit for four-layer bandaging over short-stretch seen in the previous systematic reviews. This may be because the latest trial was large and found no difference in healing rates, attributed to the fact that both technologies were in common use in the trial centres, rather than being a trial of a new bandaging technology over an existing technology. This analysis indicates that the choice of a compression system can be safely made with equal regard to clinician choice, patient preference and economic considerations as these technologies appear comparable in terms of healing rates.

The influence of patient and wound variables on healing of venous leg ulcers in a randomized controlled trial of growth-arrested allogeneic keratinocytes and fibroblasts

To examine patient and wound variables presumed to influence healing outcomes in the context of therapeutic trials for chronic venous leg ulcers. This double-blind, vehicle-controlled study was conducted with randomized assignment to one of four cell therapy dose groups (n = 46, 43, 44, 45) or vehicle control (n = 50). A 2-week run-in period was used to exclude rapid healers and those with infection or uncontrolled edema. This was a multicenter (ambulatory, private, hospital-based and university-based practices, and wound care centers in North America) study. Adults ≥ 18 years old with chronic venous insufficiency associated with an uninfected venous leg ulcer (2-12 cm(2) area, 6-104 weeks' duration) were included in the study. Excluded were pregnant or lactating women, wounds with exposed muscle, tendon or bone, patients unable to tolerate compression bandages, or patients who had exclusionary medical conditions or exposure to certain products. Exclusion during run-in included patients with infection, uncontrolled severe edema or with healing rates ≥ 0.349 cm/2 wk. Screen fail rate was 37% (134/362), and the withdrawal rate was~10% (23 of 228). Growth-arrested neonatal dermal fibroblasts and keratinocytes were delivered via pump spray in a fibrin sealant-based matrix, plus a foam dressing and four-layer compression bandaging. Treatment continued for 12 weeks or until healed, whichever occurred first. Patient demographic and wound-related variables were evaluated for influence on complete wound healing in all patients, as well as the subsets of treated and control patients. Wound duration (P = .004) and the presence of specific quantities of certain bacterial species (P < .001) affected healing in the vehicle group, while healing in the cell-treated groups was influenced by wound duration (P = .012), wound area (P = .026), wound location (P = .011), and specific quantities of certain bacterial species (P = .002). Age, sex, race, diabetes, HbA1C, peripheral neuropathy, and serum prealbumin did not significantly affect healing. Body mass index was positively associated with healing in cell-treated patients. Wound duration is a quantifiable surrogate for one or more undefined variables that can have a profound negative effect on venous leg ulcer healing. Although cell therapy overcame barriers to healing, the only specific barrier identified was the presence of certain bacterial species. Interventional trials of potentially effective new therapies can be most informative when patients with suspected barriers to healing are included. The specific measurement of candidate barriers such as microbial pathogens, wound inflammatory state, and fibroblast function should be considered in future randomized trials to improve our understanding of the basis for chronicity.

Assessment of moisture management performance of multilayer compression bandages

The moisture management property of compression bandages is a critical factor influencing the state of well-being and compliance of patients with venous and lymphatic disorders. The thermal resistance and water vapor transmission rate of compression bandages were assessed using a limb model, which allows bandage application under tension and provides valuable insight on moisture distribution across the entire ensemble under simulated wear conditions. The performance of eight commercially available two- and four-layer compression bandages was evaluated based on measurement of physical parameters, such as thickness and mass per area, moisture sorption, air permeability, water vapor permeability, and moisture distribution during the simulated wear test. The gravimetrically determined water vapor transmission of the different bandages varied from 279 to 341 g m−2 h−1. Low air permeability of padding or cohesive can indicate possible moisture barrier properties, which could cause undesirable moisture accumulation inside the bandage. Robust reproducibility of the test, along with rapidity and ease of manipulation, allows comparison between the individual products and could provide the basis of dressing performance standardization.

Spray-Applied Cell Therapy With Human Allogeneic Fibroblasts and Keratinocytes for the Treatment of Chronic Venous Leg ulcers: A Phase 2, Multicentre, Double-Blind, Randomised, Placebo-Controlled Trial

Conclusion: Venous ulcers can be healed with a spray formulation of allogeneic neonatal keratinocytes and fibroblasts without the need for tissue engineering. Summary: Venous insufficiency results from venous valve dysfunction or venous obstruction, or both, of the superficial or deep veins. Subsequent venous hypertension results in edema, tissue inflammation, and microcirculatory destruction. The end result can be a venous ulcer that can be notoriously difficult to heal, with many not responding to standard compression therapy. Surgery can result in reduced recurrence of venous ulceration, but no interventions on veins themselves have been shown to speed healing of chronic venous ulcers (Barwell JR, et al, Lancet 2004;363:1854-9). Nonsurgical therapies for venous ulceration have used tissue constructs of allogeneic adult keratinocytes. Such tissue constructs are fragile and have required incorporation of one or more dermis-like substitutes for delivery of the keratinocytes to the wound. In a large randomized controlled trial, repeated application of a tissue construct demonstrated an improvement in venous ulcer healing compared with standard compression therapy (Falanga V, Arch Dermatol 1998;134;293-300). However, allogeneic cells do not engraft. It is therefore unclear if an elaborate tissue construct is actually needed. HP802-247 is composed of cryopreserved allogeneic growth-arrested fibroblasts and keratinocytes derived from neonatal foreskin (Goedkoop R, Dermatol 2010;220:114-20). Success of foreskin-derived allogeneic keratinocytes in a two-component fibrin glue suggest that these cells can deliver essential growth factors to a nonhealing wound without the need for an elaborate tissue construct. In this study, the authors delivered growth-arrested allogeneic neonatal keratinocytes and fibroblasts to nonhealing venous ulcers using a spray, without an elaborate tissue construct. Outpatients from 28 centers in the United States and Canada with up to three ulcers, venous reflux confirmed by duplex ultrasound imaging and sufficient arterial flow for healing were randomized in a phase 2, double-blind, placebo-controlled trial. The study required that one ulcer measure between 2 and 12 cm in area and had persisted for 6 to 104 weeks. Randomization was by computer-generated block method in a 1:1:1:1:1 ratio to 5.0 × 105 cells/mL every 7 days or every 14 days, or 0.5 × 105 cells/mL every 7 days or every 14 days, or to vehicle alone every 7 days. All experimental groups received four-layer compression bandages. Trial monitors, trial sponsors, investigators, center personal, and patients were all masked to treatment allocation. The primary end point was the mean percentage change in wound area at the end of 12 weeks. Analysis was by intention to treat. There were 45 patients assigned to 5.0 × 105 cells/mL every 7 days, 44 patients to 5.0 × 105 cells/ mL every 14 days, 43 patients to 0.5 × 105 cells/mL every 7 days, 46 patients to 0.5 × 105 cells/mL every 14 days, and 50 patients to vehicle alone. There were 205 patients who completed all required study visits. Primary outcome analysis demonstrated greater mean reduction in wound area associated with active treatment compared with vehicle (P = .0446), with the dose of 0.5 × 105 cells/mL every 14 days showing the largest improvement compared with vehicle (15.98%, 95% confidence interval, 5.56-26.41; P = .0028). Adverse events were the same in all groups, with new skin ulcers and cellulitis occurring in >5% of patients. Comment: This was a large well-conducted randomized trial suggesting benefit in healing of venous leg ulcers with a spray application of allogeneic cells. This study, combined with previous work, suggested that allogeneic cell therapy for venous leg ulcers is likely to be effective. A larger study of the optimum dose of HP802-247 compared with standard therapy for venous leg ulcers seems indicated.

Spray-applied cell therapy with human allogeneic fibroblasts and keratinocytes for the treatment of chronic venous leg ulcers: a phase 2, multicentre, double-blind, randomised, placebo-controlled trial

Many patients with venous leg ulcers do not heal with standard care. HP802-247 is a novel spray-applied cell therapy containing growth-arrested allogeneic neonatal keratinocytes and fibroblasts. We compared different cell concentrations and dosing frequencies of HP802-247 for benefit and harm when applied to chronic venous leg ulcers. We enrolled adult outpatients from 28 centres in the USA and Canada with up to three ulcers, venous reflux confirmed by doppler ultrasonography, and adequate arterial flow in this phase 2, double-blind, randomised, placebo-controlled trial if at least one ulcer measured 2-12 cm(2) in area and had persisted for 6-104 weeks. Patients were randomly assigned by computer-generated block randomisation in a 1:1:1:1:1 ratio to 5·0×10(6) cells per mL every 7 days or every 14 days, or 0·5×10(6) cells per mL every 7 days or every 14 days, or to vehicle alone every 7 days. All five groups received four-layer compression bandages. The trial sponsor, trial monitors, statisticians, investigators, centre personnel, and patients were masked to treatment allocation. The primary endpoint was mean percentage change in wound area at the end of 12 weeks. Analyses were by intention to treat, excluding one patient who died of unrelated causes before first treatment. This trial is registered with ClinicalTrials.gov NCT00852995. 45 patients were assigned to 5·0×10(6) cells per mL every 7 days, 44 to 5·0×10(6) cells per mL every 14 days, 43 to 0·5 ×10(6) cells per mL every 7 days, 46 to 0·5 ×10(6) cells per mL every 14 days, and 50 to vehicle alone. All required visits were completed by 205 patients. The primary outcome analysis showed significantly greater mean reduction in wound area associated with active treatment compared with vehicle (p=0·0446), with the dose of 0·5 ×10(6) cells/mL every 14 days showing the largest improvement compared with vehicle (15·98%, 95% CI 5·56-26·41, p=0·0028). Adverse events were much the same across all groups, with only new skin ulcers and cellulitis occurring in more than 5% of patients. Venous leg ulcers can be healed with a spray formulation of allogeneic neonatal keratinocytes and fibroblasts without the need for tissue engineering, at an optimum dose of 0·5×10(6) cells per mL every 14 days. Healthpoint Biotherapeutics.

Randomized controlled trial comparing treatment outcome of two compression bandaging systems and standard care without compression in patients with venous leg ulcers

In Hong Kong, at the time of the study, compression treatment was not considered usual care for venous leg ulcer patients. This randomized controlled trial compared quality of life (QOL) aspects in venous leg ulcer patients of over 55-years of age, of short-stretch compression (SSB), four-layer compression bandaging (4LB) and usual care (UC) (moist wound healing dressing, no compression). Study period was 24-weeks, the primary outcome was the patient functional status, disease-specific and generic health-related QOL measures and ulcer healing rates, comparing week 1 vs. week 24 (end) results. Assessments included photogrammetry, Brief Pain Inventory, SF-12 Health Survey, Charing Cross Venous Ulcer Questionnaire and Frenchay Activity Index. Data analysis was performed using, where appropriate; Kaplan Meier and log rank chi-square and the repeated measures analysis of variance test. A total of 321 patients participated in the study, 45 (14%) withdrew for various reasons. Compression bandaging in both groups significantly reduced pain (P < 0.0001) and improved functional status and QOL. Healing rate at 24 weeks for both compression groups was significant (P < 0.001); for SSB this was 72.0% (77/107) vs. 67.3% in the 4LB group (72/107) and 29.0% (31/107) with usual care. The reduction in ulcer area from weeks 12 to 24 was significant only for SSB (P < 0.047). Compression was shown to be feasible for elderly community care patients in Hong Kong and is currently implemented as part of standard venous leg ulcer treatment.

Randomised Clinical Trial of Foam Sclerotherapy for Patients with a Venous Leg Ulcer

Objectives To assess whether routine use of foam sclerotherapy, in addition to four-layer compression bandaging, could speed up the healing of venous ulcers. Design Randomised controlled trial involving patients recruited from a nurse-led leg ulcer clinic. A total of 315 new patients were assessed, and eleven patients were identified from follow-up clinics. Methods Inclusion criteria were: patients with an active venous leg ulcer, in the presence of superficial truncal venous incompetence and without total deep venous incompetence on duplex imaging. Patients were randomised to four-layer compression bandages alone (control) or with additional foam sclerotherapy to incompetent superficial truncal veins. The primary endpoint was ulcer healing 24 weeks after randomisation. Results It was only possible to recruit 40 patients who were suitable for analysis: 22 control, 18 additional foam sclerotherapy. There was no complication from the foam treatment and at six months the target vein was occluded in 9 of 11 evaluable patients that had foam. One patient died before 24 weeks from an unrelated cause. At 24 weeks, 17 of 20 (85% - 1 died) in the control group and 12 of 13 (92%) patients with additional foam sclerotherapy had ulcer healing (P=0.72, log rank testing). Conclusion This trial failed to recruit sufficient patients for formal comparison, but foam sclerotherapy was feasible as an adjunct to compression therapy for venous ulceration. Trial registration: Eudra CT 2005-001551-38

Neurovascular changes after four-layer compression bandaging in people with chronic venous leg ulcers

Venous leg ulcers represent a major clinical problem, with poor rates of healing. Ideal treatment is compression bandaging. The effect of compression on neurovascular tissues involved in wound repair is unclear. This study aims to assess the effect of four-layer compression therapy (40 mmHg) on neurovascular function and wound healing in people with chronic venous leg ulcers--15 people (55 years or older) with venous leg ulcers for more than six weeks. Basal microvascular perfusion measurement (MPM), oxygen tension (tcpO2) measured at sensor temperatures of 39 degrees C and 44 degrees C and sensory nerve function using electrical cutaneous perception thresholds (ECPT) at 5, 250 and 2000 Hz (corresponding to C, Adelta and Abeta fibres) were assessed adjacent to the ulcer site, and at a mirror location on the non-ulcerated limb. Testing was undertaken before and after therapy for 5-12 weeks of four-layer compression bandaging. There was significant improvement in tcpO2 at 44 degrees C and ECPT at 2000 Hz (P < 0.05) compared with pre-intervention. Changes in basal MPM, tcpO2 at 39 degrees C and ECPT at 5 and 250 Hz after compression therapy did not reach statistical significance. Four-layer compression bandaging in people with venous leg ulcers improved some components of neurovascularture in people with chronic venous leg ulcers. Whether this improvement has contributed to wound healing in this study requires further investigation.

Immediate Hemodynamic Effect of the Additional Use of the SCD EXPRESS™ Compression System in Patients with Venous Ulcers Treated with the Four-layer Compression Bandaging System

To test the hypothesis that the SCD EXPRESS intermittent pneumatic compression applied in combination with a four-layer bandage in patients with venous ulcers increases popliteal vein volume flow and velocity. Twenty limbs of 18 patients with venous leg ulcers were studied, median age 76 years. The Total Volume Flow (TVF) and the Peak Systolic Velocity (PSV) were recorded in the popliteal vein using duplex ultrasonography. Measurements were made (i) without bandage, (ii) with four layer bandage and (iii) following the application of the SCD Compression System on top of a four-layer bandage for at least 15 minutes. The median VCSS was 17 (range, 12-22) while the median VSDS for reflux was 4.5 (range, 1-7.5). The median TVF was 71 mL/min (inter-quartile range 57-101) without bandage, 112 (IQR 89-148) with four-layer bandage and 291 (IQR 241-392) with the addition of the SCD System (P<.001, Wilcoxon signed ranks test). The median PSV was 8.4 cm/sec (IQR 6.8-14) without bandage, 13 (9.0-19) with four-layer bandage and 27 (21-31) with the addition of the SCD System (P<.001, Wilcoxon signed ranks test). Both TVF and PSV increased slightly with the addition of the four-layer bandage. However, with the addition of the SCD System these parameters increased three fold. The SCD EXPRESS Compression System accelerates venous flow in the legs of patients with venous ulcers already treated with a four-layer bandage. The combination of four-layer compression with the SCD System on healing venous ulcers needs to be tested by a clinical effectiveness study.

Measuring sub-bandage pressure: comparing the use of pressure monitors and pulse oximeters

To test the use of low-cost sub-bandage pressure monitors and pulse oximeters as part of a quality-control measure for graduated compression bandaging in leg ulcer clinics. Twenty-five healthy volunteers (mean age 40 years) providing 50 limbs were bandaged with a four-layer compression bandaging system. The ankle systolic pressure (ASP) was measured using a pulse oximeter (Nellcor NBP-40) before applying the graduated compression bandages. Interface pressure was measured by placing pressure sensors on the skin at three points (2cm above the medial malleolus; the widest part of the calf; and a point midway between them) in the supine and standing positions. The ASP was measured again with the pulse oximeter after the bandage had been applied, and the effect of the bandage on the ASP was recorded. The actual pressure created by the bandage was compared with the required pressure profile. Interface pressures varied with change of position and movement. With the operator blinded to the pressure monitors while applying the bandages, the target pressure of 35-40mmHg at the ankle was achieved in only 36% of limbs ([mean +/- 95% confidence interval]; 32.3 +/- 1.6mmHg [supine]; 38.4 +/- 2.4mmHg [standing position]). With the help of the pressure monitors, the target pressure was achieved in 78% of the limbs. There was no correlation between the pressure monitors and pulse oximeter pressures, demonstrating that the pulse oximeter is not a useful tool for measuring sub-bandage pressures. The results suggest a tool (interface pressure monitors) that is easy to operate should be available as part of quality assurance for treatment, training of care providers and education.

Randomized Clinical Trial of Four-Layer and Short-Stretch Compression Bandages for Venous Leg Ulcers (VenUS I)

Randomized Clinical Trial of Four-Layer and Short-Stretch Compression Bandages for Venous Leg Ulcers (VenUS I)