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Wound Care Technologies: Emerging Evidence for Appropriate Use in Long-Term Care
Author Affiliations: Drs. Takahashi, Chandra, and Targonski are at the Department of Internal Medicine, Division of Primary Care Medicine, Mayo Clinic; Drs. Takahashi and Targonski are also at the Mayo Clinic Robert and Arlene Kogod Program on Aging; and Mr. Kiemele is at the Department of Internal Medicine, Division of Vascular Medicine, Mayo Clinic, Rochester, MN.
Introduction
Wound management in long-term care (LTC) can present many challenges to the ultimate goal of complete wound healing. Healthcare providers frequently encounter and manage pressure ulcers, ischemic ulcers, venous ulcers, and diabetic foot (neuropathic) ulcers. All residents should be assessed for their risk of developing an ulcer. If a resident is at high risk, staff should implement aggressive maneuvers like nutritional support or pressure reduction to prevent an ulcer from occurring. If an ulcer develops, the primary goal is to completely heal the ulcer as quickly as possible and at a reasonable cost. Providers should identify ulcer type as a pressure, ischemic, venous, or neuropathic ulcer, while understanding that it can be mixed and have two or more components.1 To achieve this goal, providers should ensure good fundamental care (Table I),2 adequate nutrition, good blood supply, edema control, and excellent topical wound care. Good topical wound care enhances wound healing with a hydrating environment while minimizing necrotic tissue.3 To further achieve these goals and objectives, providers and LTC facilities often use a multidisciplinary approach. This multidisciplinary approach includes help from nursing, physical therapy, dietary, pharmacy, occupational therapy, among many others who provide wound care support. Wound care technology can be utilized in addition to standard wound care to achieve these goals by all providers.
Wound care technology continues to expand with the development of devices and dressings to assist with wound healing. Often, this technology is used to obtain healing in a nonhealing ulcer, to hasten healing of an acute or chronic ulcer, or to reduce the cost of caring for the ulcer by reducing nursing burden. The provider should possess a reasonable expectation of what each technology provides and how it will help with resident care. Many of the proposed technologies for wound care fail to evaluate all of the major healing outcomes and are very rarely studied in LTC residents. This review will evaluate the available evidence for commonly used technologies of negative pressure wound therapy (NPWT; eg, vacuum-assisted closure [VAC]), hyperbaric oxygen therapy (HBOT), pressure reduction mattresses, silver-based dressings, and ultrasonic mist. Other technologies such as growth factors,4 topical electrical stimulation,5 and maggot therapy,6 among others, are available but will not be addressed by this review.
Methods
This review used different search methods to arrive at the evidence for each individual technology. Searches were made with the broad terms of wound care and the individual therapies of interest in this review (negative pressure therapy, HBOT, silver-based therapy, and pressure mattresses), acknowledging that previous systematic reviews have been published that address, in part, these topics.7-10 Randomized controlled trials (RCTs) or meta-analyses of RCTs for each therapy published in the time period from 1960 to June 2007 included in MEDLINE or PubMed were eligible for this review. The primary measures of interest were complete wound healing, the time to wound healing, and cost-effectiveness.
Negative Pressure Wound Therapy (Vacuum Devices)
Negative pressure wound therapy is a common technology that is available in the nursing home. VAC therapy is a closed system that utilizes negative pressure to drain wound fluid away from and nutrients into a wound. Medical grade foam is placed over the wound, which is subsequently covered with a thin transparent biofilm, creating an airtight seal. Providers often utilize VAC therapy for diabetic foot ulcers or pressure ulcers. Proponents of VAC therapy believe that wound healing is accelerated by drawing fluid out of the interstitial space or decreasing bacterial load in the wound.11 The exact mechanism of effect is not known.
There were few RCTs of VAC therapy until 2005, with three RCTs in 2006 and 2007. Two different systematic reviews by both the Cochrane collaborative7 and the Agency for Healthcare Research and Quality (AHRQ)12 revealed only a small number of randomized prospective trials prior to 2005. The AHRQ review included six RCTs13-18 with 148 total subjects, 54 of whom came from a single trial.13 The overall strength of the evidence was considered to be fair with only one intention-to-treat trial.12 Both systematic reviews judged the evidence from RCTs to be inconclusive relative to the benefit of negative pressure therapy for chronic wound healing.12
The strongest and most robust science involves two RCTs in 2005 and 2008 that were published after both systematic reviews.19,20 In the first study, 162 patients were randomized to receive standard wound care (n = 85) versus negative pressure therapy (n = 77) in 18 outpatient wound care centers.19 This was an intention-to-treat analysis in subjects who had undergone a partial foot amputation. The population involved subjects with diabetic neuropathic ulcers without peripheral arterial disease. It was a slightly younger population and was predominantly male (81%). The authors found a higher complete healing rate in the negative pressure group (56%) than subjects in the standard care group (39%; P = 0.04).19 Subjects experienced faster healing rates in the VAC group as well with 100% granulation at 42 days (interquartile range [IQR], 40-56) in VAC as compared to 84 days (IQR, 57-112; P = 0.002). In the second study, 342 subjects with neuropathic diabetic foot ulcers from multiple centers were randomized to negative pressure or moist wound care.20 The primary outcome of complete healing was achieved in 43.2% of patients with negative pressure as compared to 28.9% in patients with moist wound environment (P = 0.007). It appears that negative pressure therapy may provide some potential benefit with ulcers given the findings of both studies; however, the current evidence is limited to use in diabetic foot ulcers with adequate arterial supply.
Despite better evidence of healing, cost benefit analyses have failed to show a cost savings for VAC therapy, notwithstanding lower nursing costs and faster healing times in the single study examining the question.13 Nursing must be trained to effectively use the VAC, thus adding to the overall cost. VAC therapy may improve complete healing rates and speed of healing in diabetic foot ulcers; however, it is unclear if it is cost-effective.
Hyperbaric Oxygen Therapy
HBOT has rapidly emerged as a potential alternative for healing chronic wounds since 1968.8 The biology behind the HBOT’s effectiveness has not been fully evaluated. A proposed hypothesis includes an increase in oxygen tension at the wound site.21 The etiology of chronic wounds involves reduced tissue perfusion through direct arterial ischemia or relative ischemia from edema or pressure that reduces blood flow to the skin. Some healing processes are oxygen-dependent; thus, the biological rationale for the use of HBOT. With this potential biological plausibility, providers have used HBOT for chronic wounds. The ulcer type with the most evidence is the diabetic neuropathic foot ulcer.8 The outcome of many of these studies has been amputation. This outcome is especially important for community-dwelling older adults and ambulatory LTC residents, both because of the high prevalence of this diabetic complication as well as the cost and decreased quality of life associated with amputation.
Previous systematic reviews8 have found only five RCTs that investigate HBOT in subjects with nonhealing ulcers.22-26 Four studies involved patients with diabetic foot ulcers.22,24-26 There were a total of 147 subjects in those four RCTs, with the largest trial enrolling 70 subjects. The primary outcomes for these four trials were subsequent amputation and complete wound healing. After pooled analysis, there were decreased rates of amputation in individuals who used HBOT compared to regular care (relative ratio [RR], 0.31; 95% confidence interval [CI], 0.13-0.71). The number needed to treat (NNT) was 4 (95% CI, 3-11).8 Only one trial of 18 subjects observed insignificant differences in healing at 6 months but significant differences in rates of healing at 1 year with a benefit of HBOT over standard care (62% healed in HBOT vs 0% in standard care; P = 0.026).26 Investigators evaluated the effectiveness of wound size reduction in one RCT of HBOT in subjects with venous ulcers.23 Of the 16 subjects, there was a reduction in wound size at 6 weeks; however, there was no difference in healing.23 Thus, HBOT might prevent amputations; however, improved healing rates have not been conclusively demonstrated. In general, studies of ulcer healing with HBOT were small and involved single sites.
Hyperbaric therapy has limitations. HBOT is expensive, with only one study performing a cost analysis.26 This study involved 18 randomized diabetic subjects who received HBOT or standard practices. The number of visits was lower in the HBOT group (33.75 visits/yr) as compared to the control group (136.5 visits/yr). Despite a higher £100 cost for each HBOT visit as compared to a standard wound visit (£58), the fewer visits in the HBOT group could account for a savings of £2960 a year.26 Thus, there might be cost savings; however, this was a very small trial in England and might not represent a cost savings in North America. A second major limitation is the lack of information on use of HBOT for pressure or ischemic ulcers. Both ulcer types are common in LTC, with the prevalence of stage 2 or higher pressure ulcers as high as 6.2%.27
HBOT remains an option for residents in facilities close to a hyperbaric chamber. However, many questions remain on use of HBOT in LTC residents. First, there are few data beyond the information on amputation, such as healing rates or speed of healing. Cost analysis is based upon only one study with 18 patients.26 There is no information on the use of HBOT for pressure ulcers or ischemic ulcers. Practical issues like transportation to the HBOT chamber from the facility also remain a factor. The use of HBOT as a standard therapy for residents in general should be viewed with caution, and providers should utilize HBOT when the potential benefits to the resident can be defined.
Silver-Based Therapy
Silver-based therapy is a topical treatment used in chronic wounds in LTC. Silver agents have long been recognized for their broad-spectrum activity against bacteria, viruses, and fungi, which reduces the bioburden in the wound.28 Silver agents are used primarily for the silver ion effect, which may bind to the bacterial wall and cause disruption.28 Silver can be used as a cream (silver sulfadiazine) or in a matrix with another wound therapy like an alginate or foam. There have been three RCTs evaluating silver-based therapy.29-31 Eight hundred forty-seven participants were enrolled in these three studies, with one trial having 619 subjects.31 The primary outcomes included complete healing, ulcer size post-treatment, and wound drainage. In the largest trial, the investigators found a 47% decrease in wound area with a silver foam as compared to a 32% decrease with best practice (P = 0.002).31 Exudate level in the silver group decreased from moderate to low while it stayed the same in the best practice group (P = 0.0055). Complete wound healing was not evaluated. The ulcer types noted in the study included mixed ulceration (ischemic and venous) in 21% of subjects, 46% had venous ulcers, and 8% had pressure ulcers.31 The remaining two studies found no difference in wound healing with the silver compounds.29,30 One study did show a decrease in wound size with a silver foam as compared to a standard foam (45% vs 25%). Drainage also appeared to decrease in this study, with 19% with exudate in the silver-foam group versus 49% in the foam group.29
There are limitations with the supporting evidence of silver therapy. There are no RCTs that show superiority of silver-based therapy as compared to other methods for complete wound healing. Systematic review of RCTs has also failed to support the superiority of silver therapy.9 It appears that there may be improvement in wound characteristics with decreases in drainage, exudate, maceration, pain, and size with silver therapy.31 How this correlates with clinical care in LTC has not been fully determined. Potential uses of silver-based therapy could include wounds with significant exudate, size, or pain. It is unclear how this therapy would work with ischemic ulcers. True cost analysis has not been performed for silver-based therapy; however, time for dressings has been lower in one study.31 Silver-based wound therapy can be used in LTC with the recognition of the limitations above.
Ultrasonic Mist
Ultrasonic mist is a newer wound technology based upon the effects of ultrasound using thermal and nonthermal mechanisms. Traditional contact therapeutic ultrasound is generally applied at a frequency of 1-3 MHz, while the mist unit uses ultrasound energy at 40 kHz. Low-frequency ultrasound enhances metabolism, perfusion, and granulation.32 Two RCTs evaluated ultrasonic mist and wound healing. One study was a single-center trial of 70 subjects who were randomized to either ultrasonic mist for 5 minutes 3 times a week with local best practice (LBP) or LBP alone.33 The primary outcome was 50% reduction in wound size at 12 weeks. Sixty-three percent of individuals using mist therapy achieved the primary outcome as compared to 29% with LBP (P < 0.001).33 This study population included patients with predominately ischemic ulcers with or without a venous component. A multicenter RCT with 133 subjects did examine the effectiveness of ultrasonic mist in achieving complete wound healing at 12 weeks for diabetic foot ulcers.34 Following exclusion of participants secondary to protocol violations, the investigators analyzed only 55 of the 133 randomized subjects. Using per-protocol analysis, 40.7% of subjects (n = 27) randomized to ultrasonic mist achieved complete wound healing at 12 weeks as compared to 14.3% (n = 28) in the sham group (P = 0.0366).34 However, on using intention-to-treat analysis, there was no difference between the two groups. Lastly, a follow-up retrospective study from Kavros et al35 of 167 patients with chronic wounds treated with ultrasonic mist had superior healing and speed of healing as compared to a control group.
The previous RCTs have methodological problems that weaken the validity of the findings. The larger trial did have significant healing using per-protocol analysis; however, using intention-to-treat analysis, there was no difference between the two groups. The other trial did not have blinding to the active intervention. The retrospective trial had bias from the different groups. The use of ultrasonic mist certainly might provide some improvement in healing; however, current studies leave questions as to the efficacy and effectiveness of this therapeutic modality. Additionally, there has not been a cost-effective analysis favoring ultrasonic mist over conventional wound practices.
Pressure Reduction Mattresses
Pressure reduction is one of the fundamental concepts used in treating and preventing pressure ulcers. Traditionally, frequent repositioning still provides an excellent method of pressure reduction; however, it is time- and labor-intensive and can be limited by patient characteristics and conditions. Pressure reduction mattresses are divided into different categories, with one being a continuous low pressure (CLP) device, and the other a powered device with either an alternating low pressure system or an air-fluidized system. A meta-analysis has been published that included 41 RCTs using mattresses for pressure ulcer reduction.10 Seven RCTs compared CLP mattresses to standard hospital mattresses10,36-40 and assessed the effect upon the development of pressure ulcers. A pooled relative risk of 0.40 (95% CI, 0.21-0.74) was observed.10 Powered support surfaces were reviewed, with comparisons between alternating pressure surfaces and standard mattresses as well as CLPs. One study of 482 subjects evaluated an alternating pressure surface as compared to a standard hospital mattress. The use of the alternating pressure surface significantly protected against the incidence of pressure ulcers (RR, 0.32; 95% CI, 0.14-0.74). Eight trials comparing alternating pressure with CLP for the development of pressure ulcers found mixed results.10 Cost-effective analysis for both prevention of pressure ulcers and treatment have been performed looking at both the cost of the device and the quality of life year per patient. CLPs are cost-effective for the prevention of pressure ulcers, and powered surfaces are cost-effective for treatment of pressure ulcers.41
These studies on pressure reduction mattresses demonstrate a reduction in the incidence of pressure ulcers as compared to standard mattresses, which is important for LTC. There does not appear to be one mattress or device that is markedly superior to another device. As such, it is reasonable to conclude that most high-risk individuals should be placed on a pressure reduction mattress. LTC residents would be considered high-risk in many cases, thus the potential need for widespread adoption of pressure reduction mattress in facilities. Providers should utilize powered pressure reduction devices for the highest-risk residents or in patients with ongoing deep, high-stage nonhealing pressure ulcers.
Summary
The necessity of wound technology continues to grow as the complexity and prevalence of chronic wounds increases. Evidence for using wound technology is summarized in Table II. It is clear that the most practical technology for LTC is the use of specialized wound mattresses, which provide support for frail residents and could potentially prevent new pressure ulcers. Continuous low pressure devices provide practical solutions for most needs in LTC. Providers can use negative pressure, hyperbaric oxygen, silver therapy, and ultrasonic mist as potential options for nonhealing ulcers when warranted.
The authors report no relevant financial relationships.
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4. Wieman TJ, Smiell JM, Su Y. Efficacy and safety of a topical gel formulation of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic neuropathic diabetic ulcers. A phase III randomized placebo-controlled double-blind study. Diabetes Care 1998;21(5):822-827.
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6. Sherman RA. Maggot therapy for treating diabetic foot ulcers unresponsive to conventional therapy. Diabetes Care 2003;26(2):446-451.
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8. Kranke P, Bennett M, Roeckl-Wiedmann I, Debus S. Hyperbaric oxygen therapy for chronic wounds. Cochrane Database Syst Rev 2004;(2):CD004123.
9. Vermeulen H, van Hattem JM, Storm-Versloot MN, Ubbink DT. Topical silver for treating infected wounds. Cochrane Database Syst Rev 2007;(1):CD005486.
10. Cullum N, McInnes E, Bell-Syer SE, Legood R. Support surfaces for pressure ulcer prevention. Cochrane Database Syst Rev 2004;(3):CD001735.
11. Morykwas MJ, Argenta LC, Shelton-Brown EI, McGuirt W. Vacuum-assisted closure: A new method for wound control and treatment: Animal studies and basic foundation. Ann Plast Surg 1997;38(6):553-562.
12. Samson DJ, Lefevre F, Aronson N. Wound-healing technologies: Low level laser and vacuum-assisted closure. Agency for Healthcare Research and Quality Website. www.ahrq.gov/clinic/epcsums/woundsum.htm. Accessed October 31, 2008.
13. Mouës CM, Vos MC, van den Bemd GJ, et al. Bacterial load in relation to vacuum-assisted closure wound therapy: A prospective randomized trial. Wound Repair Regen 2004;12(1):11-17.
14. Wanner MB, Schwarzl F, Strub B, et al. Vacuum-assisted wound closure for cheaper and more comfortable healing of pressure sores: A prospective study. Scand J Plast Reconstr Surg Hand Surg 2003;37(1):28-33.
15. Ford CN, Reinhard ER, Yeh D, et al. Interim analysis of a prospective, randomized trial of vacuum-assisted closure versus the healthpoint system in the management of pressure ulcers. Ann Plast Surg 2002;49(1):55-61.
16. Eginton MT, Brown KR, Seabrook GR, et al. A prospective randomized evaluation of negative-pressure wound dressings for diabetic foot wounds. Ann Vasc Surg 2003;17(6):645-649. Published Online: October 13, 2003.
17. McCallon SK, Knight CA, Valiulus JP, et al. Vacuum-assisted closure versus saline-moistened gauze in the healing of postoperative diabetic foot wounds. Ostomy Wound Manage 2000;46(8):28-32, 34.
18. Joseph E, Hamori C, Bergman S, et al. A prospective randomized trial of vacuum-assisted closure versus standard therapy of chronic nonhealing wounds. Wounds 2002;12:60-67.
19. Armstrong DG, Lavery LA; Diabetic Foot Study Consortium. Negative pressure wound therapy after partial diabetic foot amputation: A multicentre, randomised controlled trial. Lancet 2005;366(9498):1704-1710.
20. Blume PA, Walters J, Payne W, et al. Comparison of negative pressure wound therapy using vacuum-assisted closure with advanced moist wound therapy in the treatment of diabetic foot ulcers: A multicenter randomized controlled trial. Diabetes Care 2008;31(4):631-636. Published Online: December 12, 2007.
21. Knighton DR, Hunt TK, Scheuenstuhl H, et al. Oxygen tension regulates the expression of angiogenesis factor by macrophages. Science 1983;221(4617):1283-1285.
22. Lin TF, Chen SB, Niu KC. The vascular effects of hyperbaric oxygen therapy in treatment of early diabetic foot ulcers. Undersea Hyper Med 2001;28(Suppl):67.
23. Hammarlund C, Sundberg T. Hyperbaric oxygen reduced size of chronic leg ulcers: A randomized double-blind study. Plast Reconstr Surg 1994;93(4):829-834.
24. Faglia E, Favales F, Aldeghi A, et al. Adjunctive systemic hyperbaric oxygen therapy in treatment of severe prevalently ischemic diabetic foot ulcer. A randomized study. Diabetes Care 1996;19(12):1338-1343.
25. Doctor N, Pandya S, Supe A. Hyperbaric oxygen therapy in diabetic foot. J Postgrad Med 1992;38(3):112-114.
26. Abidia A, Laden G, Kuhan G, et al. The role of hyperbaric oxygen therapy in ischaemic diabetic lower extremity ulcers: A double-blind randomised-controlled trial. Eur J Vasc Endovasc Surg 2003;25(6):513-518.
27. Brandeis GH, Berlowitz DR, Hossain M, Morris JN. Pressure ulcers: The Minimum Data Set and the Resident Assessment Protocol [published correction appears in Adv Wound Care 1996;9(6):8]. Adv Wound Care 1995;8(6):18-25.
28. Lansdown AB. Silver in health care: Antimicrobial effects and safety in use. Curr Probl Dermatol 2006;33:17-34.
29. Jorgensen B, Price P, Andersen KE, et al. The silver-releasing foam dressing, Contreet Foam, promotes faster healing of critically colonised venous leg ulcers: A randomised, controlled trial. Int Wound J 2005;2(1):64-73.
30. Meaume S, Vallet D, Morere MN, Téot L. Evaluation of a silver-releasing hydroalginate dressing in chronic wounds with signs of local infection [published correction appears in J Wound Care 2005;14(10):479]. J Wound Care 2005;14(9):411-419.
31. Munter KC, Beele H, Russell L, et al. Effect of a sustained silver-releasing dressing on ulcers with delayed healing: The CONTOP study. J Wound Care 2006;15(5):199-206.
32. Gehling ML, Samies JH. The effect of noncontact, low-intensity, low-frequency therapeutic ultrasound on lower-extremity chronic wound pain: A retrospective chart review. Ostomy Wound Manage 2007;53(3):44-50.
33. Kavros SJ, Miller JL, Hanna SW. Treatment of ischemic wounds with noncontact, low-frequency ultrasound: The Mayo Clinic experience, 2004-2006. Adv Skin Wound Care 2007;20(4):221-226.
34. Ennis WJ, Foremann P, Mozen N, et al. Ultrasound therapy for recalcitrant diabetic foot ulcers: Results of a randomized, double-blind, controlled, multicenter study [published correction appears in Ostomy Wound Manage 2005;51(9):14]. Ostomy Wound Manage 2005;51(8):24-39.
35. Kavros SJ, Liedl DA, Boon AJ, et al. Expedited wound healing with noncontact, low-frequency ultrasound therapy in chronic wounds: a retrospective analysis. Adv Skin Wound Care 2008;21(9):416-423.
36. Andersen KE, Jensen O, Kvorning SA, Bach E. Decubitus prophylaxis: A prospective trial on the efficiency of alternating pressure air mattresses and water mattresses. Acta Derm Venereol 1983;63:227-230.
37. Collier ME. Pressure-reducing mattresses. J Wound Care 1996;5(5):207-211.
38. Goldstone LA, Norris M, O'Reilly M, White J. A clinical trial of a bead bed system for the prevention of pressure sores in elderly orthopaedic patients. J Adv Nurs 1982;7(6):545-548.
39. Gray DG, Campbell MA. A randomized clinicial trial of two types of foam mattresses. J Tissue Viability 1994;4:128-132.
40. Hofman A, Geelkerken RH, Wille J, et al. Pressure sores and pressure-decreasing mattresses: Controlled clinical trial. Lancet 1994;343(8897):568-571.
41. Fleurence RL. Cost-effectiveness of pressure-relieving devices for the prevention and treatment of pressure ulcers. Int J Technol Assess Health Care 2005;21(3):334-341.
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