Table 2.
Charactristics of included systematic reviews
No | Author/Date Country | databases searched | Objective | Type of intervention | Included Population | Number of included studies and Study designs | Method of risk of bias/quality assessment | outcomes reported in the review | Authors conclusion | Study rating | ||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Efficacy | safety | cost | ||||||||||
1 | Samson D./ Spain 2004 [23] | 3(medline/embase/cochrane) | “to systematically review and synthesize the available evidence on the effectiveness of vacuum-assisted closure(VAC) for wound healing” | VAC vs. moist gauze dressings | 20 people with diabetic foot ulcer | 2 RCT [41, 42] | Harris rating system [43] | Change in wound area, incidence of complete wound closure, time to complete closure, adverse events | Inconclusive | N/A | N/A | High |
There was not any significant advantage with regard to VAC therapy. However the evidence from the RCTs were poor | ||||||||||||
2 | Pham C. / Australia 2006 [24] | 3(medline/embase/cochrane) | “To review the efficacy and safety outcomes of topical negative pressure(TNP) in treating particular wound types” | TNP vs. conventional method | 51 people with diabetic foot ulcer | 2RCT and 1 case series [41, 42, 44] | N/R | Wound closure, adverse events | Inconclusive | Inconclusive | N/A | Critically Low |
There is a lack of high-quality reports with sufficient sample sizes to detect any differences between NPWT and conventional method | ||||||||||||
3 | Noble-Bell G, et.al UK 2008 [16] | 4(the Cochrane register of controlled trials, Medline, Embase and CINHAL, | To systematically review the evidence relating to the effectiveness of NPWT in the management of diabetes foot ulcers | NPWT vs. conventional dressings | 206 either type1 or type 2diabetic Patients with, chronic or acute wounds, including postoperative wounds | 4 RCT [41, 42, 45, 46] | JADAD criteria | time to wound healing, Treatment related complications, cost-effectiveness | Beneficial | Beneficial | Inconclusive | High |
Negative-pressure wound therapy may be particularly beneficial for diabetic foot ulcer healing without any major adverse events, however the studies quality were weak to moderate | ||||||||||||
4 | Vikatmaa, P., et al. Finland 2008 [13] | 2 (Cochrane, medline) | To gather the most reliable evidence available on the effectiveness and safety of NPWT in the treatment of acute and chronic wounds | NPWT vs. any other local wound therapy | 206 2diabetic Patients with foot ulcer | 4 RCT [41, 42, 45, 46] | Harris rating system [43] | time needed to reepithelialization, Second amputation, wound area, reduction, | Beneficial | Beneficial | N/A | Low |
NPWT was at least as effective and in some cases more effective than the control treatment., however the quality of studies were poor | ||||||||||||
5 | *Gregor S, et al. Germany 2008 [35] | 4(MEDLINE, EMBASE, CINAHL, and the Cochrane Library) | To assess the clinical effectiveness and safety of NPWT vs conventional wound therapy | NPWT vs.conventional wound dressing | 206 patients with diabetic foot amputations or chronic diabetic wounds | 2 RCT, 2 non-RCT [41, 42, 45, 46] | trials were assessed for their quality using IQWiG | Incidence and Time to wound closure, safety | Inconclusive | inconclusive | N/A | High |
Although there is some indication that NPWT may improve wound healing, the body of evidence available is insufficient to clearly prove an additional clinical benefit of NPWT. The large number of prematurely terminated and unpublished trials is reason for concern. | ||||||||||||
6 | Hinchliffe RJ/ UK/ 2008 [25] | 4 (Medline, Embase, the Cochrane database of systematic reviews, and the Cochrane Central Controlled Trials Register | “to identify interventions for which there is evidence of effectiveness” | NPWT efficacy vs. Saline moistened gauze, standard care | 182 people older than 18 with either type 1 or 2 with chronic foot ulcers or post-amputation wounds | 3 RCT [41, 42, 45] | Dutch Cochrane Center (www.cochrane.nl/index.html) | Ulcer healing time to healing, reduction in ulcer area | Beneficial | Beneficial | N/A | Low |
NPWT therapy have been shown to improve the rate of healing after post-amputation wounds, however further evidence is required to substantiate the benefit and cost–benefit of TNP therapy after post-amputation wounds, as well as in the non-operated chronic wound. | ||||||||||||
7 | Ubbink/ netherland2008a [22] | 4(Cinahl, Embase and Medline and the Cochrane controlled trials register | “to summarize up-to-date, high-level evidence on the effectiveness of TNP on wound healing, in both acute and chronic settings” | TNP effectiveness vs. Saline moistened gauze | 206 diabetic patients | 4 RCT [41, 42, 45, 46] | Dutch Cochrane Collaboration checklist (www.cochrane.nl). | wound healing adverse events | Inconclusive | N/A | N/A | Low |
There is no valuable evidence to support the use of TNP in the treatment of chronic wounds, when compared to MGWD or other topical wounds dressing. | ||||||||||||
8 | Ubbink DT, Netherlands, 2008b [26] | 4(Ovid EMBASE, Ovid CINAHL, The Cochrane Library, Ovid MEDLINE) | To determine: if TNP is more effective than alternative wound dressings in terms of healing rates, costs, quality of life, pain management and comfort for people with chronic wounds | effects of TNP vs. | 20 people with chronic diabetic foot ulcer | 2RCT [41, 42] | Dutch Cochrane Collaboration checklis | Time to complete healing, Rate of change in wound area, Proportion of wounds completely healed, Adverse events., Costs | Inconclusive | N/A | N/A | High |
There are methodological flaws regarding with trials comparing TNP with alternative treatments in chronic wounds. Although data demonstrate a beneficial effect of TNP on wound healing, more better quality research is needed. | ||||||||||||
9 | Ontario Health Technology Assessment Series, Canada, 2010 [27] | 5(PubMed, Embase, CINAHL,the Cochrane Library INAHT) | to review the NPWT technique regarding efficacy and safety in the management of skin ulcers | NPWT vs. moist wound therapy or AMWT | 504 people who had diabetic ulcer and amputation wounds | 2RCT [8, 46] | Pedro Scale | complete wound closure, Granulation tissue formation, time to granulation tissue formation, rate of secondary amputation and other adverse events, cost-effectiveness | Beneficial | N/A | Inconclusive | High |
Time to complete healing was significantly shorter in NPWT groups vs. controls Proportion of patients who achieved complete ulcer closure in NPWT was significantly greater than in controls in both studies | ||||||||||||
10 | Xie X. et al./Canada/ 2010 [12] | 2 (PubMed and Embase,) | to estimate the efficacy of negative pressure wound therapy (NPWT) | NPWT compared to any standardwound dressing | 580 people who had diabetic ulcer | 7RCT [8, 41, 42, 45–48] | PEDro Scale | rate of wound healing | Beneficial | N/A | N/A | Critical low |
There is now sufficient evidence to show that NPWT will accelerate healing of diabetes-associated chronic lower extremity wounds. | ||||||||||||
11 | C.A. Fries, et al. United Kingdom 2011 [28] | 5(Cinahl, Embase, Medline, ProQuest and the Cochrane Library) | to conduct a review of the evidence supporting the effectiveness use of TNP in trauma patients | N/A | 206 Patients with diabetic foot ulcers | 4 RCT [41, 42, 45, 46] | N/R | Rate of time healing, rate of complete closure, wound depth | Beneficial | N/A | N/A | Critical low |
All trials suggest that wound healing rates and reduction of wound surface area is improved by TNP | ||||||||||||
12 | F.L. game / / UK 2012 [11] | 3(Medline, Embase, clinical trials registries) | N/A | NPWT vs. standard wound care | chronic foot ulcers in diabetic people older than 18 with either type 1 or 2 | 3 RCT included 375diabetic foot patients and 1 cohort included 16,319 diabetic foot patients [8, 47–49] |
Scottish Intercollegiate Guidelines Network criteria. |
Wound healing, time to healing, reduction in ulcer area or amputation | Beneficial | Beneficial | N/A | Low |
Weakly significant benefit of NPWT in reduced healing time, increased incidence of healing and reduced risk of minor amputation is for diabetic foot ulcers. | ||||||||||||
13 | Yarwood L UK, 2012 [29] | 3(CINAHL, MEDLINE and the Cochrane Library | Seeks to review the effectiveness of NPWT and conventional wound_dressings | NPWT vs.conventional wound dressings | 640 people with diabetic foot ulcer | 4 RCT [8, 41, 46, 50] | N/A | Granulation tissue formation, healing time, wound surface area reduction, adverse events, cost | Beneficial | Beneficial | Beneficial | Low |
NPWT has proven to be more effective than conventional Wound dressings. However further studies are needed evaluating cost-effectiveness and patients accessibility. | ||||||||||||
14 | Quecedo L/ Spain/ 2013 [30] | 5(medline, ebbase, NHS, HTAD, chocrane library, Aggressive research website) | to analyze the scientific evidence from clinical trials that evaluate the effectiveness and safety of NPWT in the treatment of diabetic wounds | NPWT vs. conventional therapies | 570 people aged 18 years or affected by complicated foot injuries or postoperative wounds | 6RCT [41, 42, 45, 46, 48, 51] | The Jaddad criteria | healing time, adverse events, costs | Beneficial | Beneficial | Beneficial | Critical low |
It could be possible to make a recommendation for its use given the safety profile and costs and consistency of the results, in spite of the low quality grade of evidence. | ||||||||||||
15 | Greer, N, et al. USA 2013 [14] | 2 (MEDLINE, Cochrane Library) | to systematically evaluate the efficacy and harms of NPWT | NPWT vs. standard care | 342 diabetic patients | 1 RCT [8] |
modifide Cochrane Approach to determining risk of bias [52] |
Percentage of ulcer healed, healing time, adverse events, | Beneficial | N/A | N/A | low |
This good-quality study found improved healing with NPWT | ||||||||||||
16 | Dumville, UK, 2013 [15] | 6(Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL); The Database of Abstracts of Reviews of Effects (DARE),The NHS Economic Evaluation Database,MEDLINE, EMBASE; and EBSCO CINAHL | To assess the effects of NPWT in the healing of foot wounds in people with diabetes mellitus | NPWT vs. standard care or adjuvant therapies | 605 diabetic patients with Type 1 or 2 DM, with foot wounds below the knee, regardless of underlying etiology | 5RCT [8, 46, 50, 53, 54] | Cochrane Collaboration tool for assessing risk of bias | Complete wound healing, amputation adverse events, | Inconclusive | Inconclusive | Inconclusive | High |
There is some evidence to suggest that NPWT is more effective in healing diabetic post-operative foot wounds compared with moist wound dressing | ||||||||||||
17 | Guffani A,USA, 2014 [31] | 2(pubmed, OVID) | to address the effectiveness and safety of NPWT for wound healing in patients with a diabetic foot | NPWT vs. SMWT | 545 diabetic Patients with chronic or acute diabetic foot ulcers | 4 RCT [8, 45, 46, 48] | N/R | wound closure rate, safety and reduction in secondary complications | Beneficial | Beneficial | N/A | Critical low |
Evidence from 4 randomized controlled trials suggests that NPWT using a VAC system is more effective than Standard Moist Wound Therapy(SMWT) in promoting the healing of diabetic foot wounds and is safe and effective for management of diabetic foot ulcers | ||||||||||||
18 | *Zhang, Jian, et al. China 2014 [37] | 3(PubMed, EMBASE, and Cochrane Library databases) | To evaluate the effectiveness and safety of negative-pressure wound therapy for diabetic foot ulcers | NPWT Vs. with standard wound care | 669 diabetic foot patients with any chronic foot wound and postoperative wounds in type 1 or 2patients diabetic | 8 RCT [8, 41, 42, 45, 46, 48, 50, 55] | Cochrane Handbook for Systematic Reviews of Interventions | ulcer healing, time to ulcer healing, adverse events | Beneficial | Beneficial | N/A | low |
Negative-pressure wound therapy appears to be more effective for diabetic foot ulcers compared with non–negative-pressure wound therapy, and has a similar safety profile. | ||||||||||||
19 | * Wang R/ China/ 2015 [36] | 5(PubMed, Ovid EMBASE and Web of Science, Cochrane library and Chinese biomedicine literatures databases | “To compare the strength and weakness of negative pressure wound therapy (NPWT) with ultrasound debridement (UD) as for diabetic foot ulcers (DFU)” | NPWT vs.standard wound care | 2800 Patients with diabetic foot ulcers | 8 RCT [8, 42, 45–48, 50, 55]and **22 compared studies | Modified JADAD criteria | full epithelialization, Time to wound closure, decrement in ulcer area, secondary amputation | Beneficial | Beneficial | N/A | Critical low |
NPWT significantly improved the proportion of diabetic foot ulcer healing compared with standard wound care | ||||||||||||
20 | Peters E.J./ The Netherland/2016 [33] | 2(PubMed, Embase) | To review the effectiveness of NPWT on infection control in diabetic foot ulcers | NPWT vs. advanced wound dressing | 130 people aged 18 years or older who had diabetes and foot infection | 1RCT [56] | Dutch Cochrane Centre | Wound healing, infection control | Inconclusive | Inconclusive | N/A | Critical low |
There is no sufficient conclusions about the usefulness of the NPWT | ||||||||||||
21 | Game, F. L., et al. UK & USA2016 [32] | 2(MEDLINE, Cochrane Library) | to review the NPWT effectiveness in healing of chronic ulcers of the foot in diabetes | NPWT vs. Standard care or advanced wound dressing | 297 chronic foot ulcers in diabetic people older than 18 with either type 1 or 2 | 3 RCT [50, 55, 56] | Scottish Intercollegiate Guidelines Network criteria [57] | healing, time to healing, and/or reduction in ulcer area, cost | Inconclusive | N/A | Inconclusive | Critical low |
The evidence to support the NPWT effectiveness and cost effectiveness in diabetic foot ulcers is not strong | ||||||||||||
22 | *Liu, Si, et al. 2017 China [18] | 5(Cochrane Library, MEDLINE, EMBASE, Ovid, and Chinese Biological Medicine databases) | “to assess the clinical efficacy, safety, and cost-effectiveness of NPWT in the treatment of DFUs” | NPWT vs. standard dressing changes | 1044 Patients with chronic diabetic foot ulcers | 11 RCT [8, 41, 42, 46, 48, 50, 55, 58–61] | Cochrane Collaboration tool for assessing risk of bias | healing time, reduction in ulcer area reduction in ulcer depth,amputations, treatment-related adverse effects, cost-effectiveness | Beneficial | Beneficial | Beneficial | High |
All trials suggested that: Higher rate of complete healing, shorter healing time, and fewer amputations. | ||||||||||||
23 | Gonzalez-Ruiz, M Spain 2018 [34] Article in spanish | 4(PubMed, CINAHL, SciELO and Web of Science) | To conduct a systematic review for analyze the effectiveness of TNP in ulcers of diabetic patients | TPN Vs.conventional dressing | 967 people with diabetic foot ulcer | 12 RCT [8, 41, 45, 47, 48, 50, 51, 55, 62–65] | JADAD scale | Wound surface area, time to granulation, quality of life cost | Beneficial | Beneficial | Beneficial | low |
TPN achieve a greater surface of granulation tissue and faster healing time. Even so, future studies are needed to evaluate the impact of TPN with the aim of incorporating it into daily clinical practice. |
VAC vacuum assisted closure, RCT randomized controlled trial, NPWT negative pressure wound therapy, N/A not aplicable, TNP topical negative pressure, N/R not reported, MGWD moist gauze wound dressing, DFU diabetic foot ulcer, SWC standard wound care
*Meta-analyses
**these studies are not mentioned in this overview