Dataset Information

[Effectiveness of double-layered compression therapy against crepe bandage for healing venous ulcers in primary care. Randomized clinical trial].

ABSTRACT:

Objective

To evaluate if the two-layer bandage is more effective than the crepe bandage in the healing of venous ulcers after 12 weeks of follow-up.

Design

Randomized multicentre controlled clinical trial.

Location

22 Primary Health Centers of Madrid.

Participants

Over 18 years old, with diagnosis of venous ulcers. 93 patients were randomized, 56 in the double layer group and 37 in the crepe group. Withdrawals: 16 in double layer group, 7 in crepe group.

Interventions

Control group: usual clinical practice: treatment of the wound and bandage with crepe. Experimental group: same usual clinical practice for wound treatment and bandage with double layer.

Main measurements

Primary outcome: complete healing at 12 weeks.

Secondary outcomes

severity of ulceration, health-related quality of life, adverse events. Blind evaluation of the response variable.

Results

Complete healing: in crepe group, 25, 67.5% (95% CI 50.2-81.9) and in double layer group, 32, 57.1% (95% CI 43.2-70.3). No evidence of a difference in both groups, RR=1.10 (95% CI 0.864-1.424). The basal severity of the ulcers is associated with the healing time. HR=0.86 (95% CI 0.78-0.94). Our data showed a significant improvement in health-related quality of life, total and in the of cosmesis and emotional dimensions. No evidence of a difference in both groups. We didn't find serious adverse events in any of the groups.

Conclusions

We didn't find significant differences in the healing between the two bandages evaluated. Both are appropriate for ulcer healing and to improve the health-related quality of life.

SUBMITTER: Folguera-Alvarez C

PROVIDER: S-EPMC8054279 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundChronic venous insufficiency, in its final stage can cause venous ulcers. Venous ulcers have a prevalence of 0.5 % to 0.8 % in the general population, and increases starting at 60 years of age. This condition often causes increased dependency in affected individuals, as well as a perceived reduced quality of life and family overload. Local Treating chronic venous ulcers has 2 components: topically healing the ulcer and controlling the venous insufficiency. There is evidence that compressive therapy favours the healing process of venous ulcers. The studies we have found suggest that the use of multilayer bandage systems is more effective than the use of bandages with a single component, these are mostly using in Spain. Multilayer compression bandages with 2 layers are equally effective in the healing process of chronic venous ulcers as 4-layer bandages and are better tolerated and preferenced by patients. More studies are needed to specifically compare the 2-layer bandages systems in the settings where these patients are usually treated.Method/designRandomised, controlled, parallel, multicentre clinical trial, with 12 weeks of follow-up and blind evaluation of the response variable. The objective is to assess the efficacy of multilayer compression bandages (2 layers) compared with crepe bandages, based on the incidence of healed venous ulcers in individuals treated in primary care nursing consultations, at 12 weeks of follow-up. The study will include 216 individuals (108 per branch) with venous ulcers treated in primary care nursing consultations. The primary endpoint is complete healing at 12 weeks of follow-up. The secondary endpoints are the degree of healing (Resvech.2), quality of life (CCVUQ-e), adverse reactions related to the healing process. Prognosis and demographic variables are also recorder. Effectiveness analysis using Kaplan-Meier curves, a log-rank test and a Cox regression analysis. The analysis was performed by intention to treat.DiscussionThe study results can contribute to improving the care and quality of life of patients with venous ulcers, decreasing healing times and healthcare expenditure and contributing to the consistent treatment of these lesions.Trial registrationThis study has been recorded in the Clinical Trials.gov site with the code NCT02364921. 17 February 2015.

Project description:Background: Chronic venous leg ulceration is a common and costly clinical issue across the world, affecting up to 3 in 1,000 people. Compression therapy is recommended as the gold standard treatment in clinical practice, although a large number of venous leg ulcers remain unhealed after several years. Physical activity may improve healing although there is limited evidence on the effects of physical activity as an adjuvant treatment to compression to improve venous leg ulcers healing and prevent recurrence. Objectives: This scoping review protocol aims to systematically search, appraise, and synthesize quantitative research evidence to assess the effect of physical activity interventions applied in conjunction with compression therapy on venous leg ulcer healing and recurrence. Methods and Analysis: We will use the methodology framework suggested by Arksey and O'Malley, Levac et al., the JBI as a guide. We will also follow the three-step search strategy recommended by the JBI to systematic search for relevant published research, ongoing clinical trials, and grey literature. Two review authors will independently screen titles and abstracts followed by full-text review to determine final eligibility for inclusion. The search process will be reported using a Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow chart. Characteristics of physical activity interventions, primary outcomes related to ulcer healing and recurrence, and secondary outcomes of interest included quality of life, pain level, adverse effects, and economic costs will be extracted and summarized. The review will provide a descriptive account of the findings from included studies. Where appropriate, data will be pooled for a meta-analysis using a random effects model. Discussion: Physical activity interventions represent a low-cost, potentially useful adjuvant treatment to compression therapy for the management of venous leg ulcers. Several gaps in knowledge remain that are answerable via a targeted scoping review. This protocol outlines the rationale, objectives, and the planned methodology for conducting the study. Ethics and Dissemination: The scoping review will use data from publicly available sources and ethical approval is not required. Findings from this review will be submitted to a peer-reviewed journal, presented at relevant conferences and disseminated via social media.

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