Norman G, Westby MJ, Rithalia AD, Stubbs N, Soares MO, Dumville JC, et al.
The Cochrane database of systematic reviews. Date of publication 2018 Jun 15;volume 6():CD012583.
1. Cochrane Database Syst Rev. 2018 Jun 15;6:CD012583. doi:
10.1002/14651858.CD012583.pub2.
Dressings and topical agents for treating venous leg ulcers.
Norman G(1), Westby MJ, Rithalia AD, Stubbs N, Soares MO, Dumville JC.
Author information:
(1)Division of Nursing, Midwifery and Social Work, School of Health Sciences,
Faculty of Biology, Medicine and Health, University of Manchester, Manchester
Academic Health Science Centre, Jean McFarlane Building, Oxford Road, Manchester,
UK, M13 9PL.
BACKGROUND: Venous leg ulcers are open skin wounds on the lower leg which can be
slow to heal, and are both painful and costly. The point prevalence of open
venous leg ulcers in the UK is about 3 cases per 10,000 people, and many people
experience recurrent episodes of prolonged ulceration. First-line treatment for
venous leg ulcers is compression therapy, but a wide range of dressings and
topical treatments are also used. This diversity of treatments makes
evidence-based decision-making challenging, and a clear and current overview of
all the evidence is required. This review is a network meta-analysis (NMA) which
assesses the probability of complete ulcer healing associated with alternative
dressings and topical agents.
OBJECTIVES: To assess the effects of (1) dressings and (2) topical agents for
healing venous leg ulcers in any care setting and to rank treatments in order of
effectiveness, with assessment of uncertainty and evidence quality.
SEARCH METHODS: In March 2017 we searched the Cochrane Wounds Specialised
Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid
MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid Embase and
EBSCO CINAHL Plus. We also scanned reference lists of relevant included studies
as well as reviews, meta-analyses, guidelines and health technology reports to
identify additional studies. There were no restrictions with respect to language,
date of publication or study setting. We updated this search in March 2018; as a
result several studies are awaiting classification.
SELECTION CRITERIA: We included published or unpublished randomised controlled
trials (RCTs) that enrolled adults with venous leg ulcers and compared the
effects of at least one of the following interventions with any other
intervention in the treatment of venous leg ulcers: any dressing, or any topical
agent applied directly to an open venous leg ulcer and left in situ. We excluded
from this review dressings attached to external devices such as negative pressure
wound therapies, skin grafts, growth factors and other biological agents, larval
therapy and treatments such as laser, heat or ultrasound. Studies were required
to report complete wound healing to be eligible.
DATA COLLECTION AND ANALYSIS: Two review authors independently performed study
selection, 'Risk of bias' assessment and data extraction. We conducted this NMA
using frequentist meta-regression methods for the efficacy outcome; the
probability of complete healing. We assumed that treatment effects were similar
within dressings classes (e.g. hydrocolloid, foam). We present estimates of
effect with their 95% confidence intervals (CIs) for individual treatments
focusing on comparisons with widely used dressing classes, and we report ranking
probabilities for each intervention (probability of being the best, second best,
etc treatment). We assessed the certainty (quality) of the body of evidence using
GRADE for each network comparison and for the network as whole.
MAIN RESULTS: We included 78 RCTs (7014 participants) in this review. Of these,
59 studies (5156 participants, 25 different interventions) were included in the
NMA; resulting in 40 direct contrasts which informed 300 mixed-treatment
contrasts.The evidence for the network as a whole was of low certainty. This
judgement was based on the sparsity of the network leading to imprecision and the
general high risk of bias in the included studies. Sensitivity analyses also
demonstrated instability in key aspects of the network and results are reported
for the extended sensitivity analysis. Evidence for individual contrasts was
mainly judged to be low or very low certainty.The uncertainty was perpetuated
when the results were considered by ranking the treatments in terms of the
probability that they were the most effective for ulcer healing, with many
treatments having similar, low, probabilities of being the best treatment. The
two most highly-ranked treatments both had more than 50% probability of being the
best (sucralfate and silver dressings). However, the data for sucralfate was from
one small study, which means that this finding should be interpreted with
caution. When exploring the data for silver and sucralfate compared with
widely-used dressing classes, there was some evidence that silver dressings may
increase the probability of venous leg ulcer healing, compared with nonadherent
dressings: RR 2.43, 95% CI 1.58 to 3.74 (moderate-certainty evidence in the
context of a low-certainty network). For all other combinations of these five
interventions it was unclear whether the intervention increased the probability
of healing; in each case this was low- or very low-certainty evidence as a
consequence of one or more of imprecision, risk of bias and inconsistency.
AUTHORS' CONCLUSIONS: More research is needed to determine whether particular
dressings or topical agents improve the probability of healing of venous leg
ulcers. However, the NMA is uninformative regarding which interventions might
best be included in a large trial, largely because of the low certainty of the
whole network and of individual comparisons.The results of this NMA focus
exclusively on complete healing; whilst this is of key importance to people
living with venous leg ulcers, clinicians may wish to take into account other
patient-important outcomes and factors such as patient preference and cost.
DOI: 10.1002/14651858.CD012583.pub2
PMID: 29906322 [Indexed for MEDLINE]
