Current Thoughts for the Prevention and Treatment of Pressure Ulcers Using the Evidence to Determine Fact or Fiction
Steven M. Levine, MD, Sammy Sinno, MD, Jamie P. Levine, MD, and Pierre B. Saadeh, MD
Objective: To use an evidenced-based approach to better understand the management and treatment of pressure ulcers.
Background: Pressure sores are a cause of signiﬁcant morbidity in the medical community. Although there are a multitude of preventative and treatment options, there remains some degree of uncertainty in the literature in deﬁning the best way to treat and manage pressure sores.
Methods: An exhaustive literature search was performed using several electronic databases. The search revealed several identiﬁed modalities for treatment and/or prevention of pressure ulcers. We then assessed each modality individually for the level of evidence that exists in the most current literature, with preference given to more recent studies (2005 to present).
Results: We reviewed the most relevant, high-level evidence that exists for the following modalities for understanding, preventing, and treating pressure ulcers: wound cleansers, repositioning, negative pressure therapy, debridement, enteral and parenteral feeding, vitamin and mineral supplementation, specialized mattresses, ultrasound therapy, honey, cellular therapy, musculocutaneous and fasciocutaneous ﬂap closure, and other miscellaneous therapies.
Conclusions: Although many of these modalities are used, we encourage clinicians and health care providers to consider the evidence-based data when deciding how to most appropriately manage their patients’ pressure sores.
Keywords: evidence-based, decubitus ulcers, pressure ulcers, pressure ulcer treatment, prevention of prevention ulcers
Pressure ulcers, also known as decubitus ulcers, are a signiﬁcant cause of morbidity. It has been reported that anywhere from 2% to 28% of nursing home residents experience pressure ulcers. These wounds result from sustained pressure against the skin and cause a local inﬂammatory reaction, potentially leading to bacterial contamination or systemic disease. The severity of pressure ulcers varies according to the amount and quality of tissue involved. The grading system used to classify these wounds is shown in Table 1.2
Certain identiﬁable risk factors have been shown to be associated with development of pressure ulcers. One study showed that incontinence, smoking, hypoalbuminemia, alcoholism, and diabetes were all associated with pressure ulcer formation. Pressure and friction have both been shown experimentally to increase susceptibility to decubitus ulcer formation.
Although there are a variety of treatment modalities available for pressure ulcers, there is no widely accepted algorithm for treatment. Consequently, there is some confusion in terms of appropriately understanding and treating these wounds most effectively. The purpose of this article was to review current modalities in preventing and treating pressure ulcers.
Electronic searches were performed using the following databases: the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE (1950 to August 2011), Ovid EMBASE (1980 to August 2011), Ovid CINAHL (1982 to August 2011), and Google Scholar. The following key words were then searched in each of the databases: “pressure sores,” “pressure ulcers,” “decubitus ulcers,” “treatment of pressure sores,” “treatment of pressure ulcers,” “treatment of decubitus ulcers,” “prevention of pressure sores,” “prevention of pressure ulcers,” “prevention of decubitus ulcers.” The titles and abstracts from the initial literature search were appraised to identify articles for full review, and the reference sections from each article were searched manually for relevant publications. Several nonEnglish articles of interest were reviewed if their English translation was available.
The search revealed several identiﬁed modalities for treatment and/or prevention of pressure ulcers. We then assessed each modality individually for the level of evidence that exists in the most current literature, with preference given to more recent studies (2005 to present). Table 2 gives a summary of the levels of evidence for the reviewed literature.
Modalities for Prevention and Treatment of Pressure Sores
Wound Cleansers (Level II)
Topical therapies in the form of wound cleansers have long been believed to play a role in ulcer healing.6 By removing dead tissue and foreign bodies from the wound, wound cleansers prepare the wound bed for dressing application. Although most of the data that exist for wound cleansers are largely anecdotal, double-blindedrandomized controlled trials have demonstrated the efﬁcacy of saline spray containing aloe, silver chloride, and decyl glucoside in improving ulcer healing when compared with saline alone.
Repositioning (Level V)
Although repositioning is commonly used to prevent pressure ulcer formation, to date, there are no randomized controlled trials that support this intervention. Several studies have examined the frequency of positioning or optimal position for patients with pressure ulcers, yet the evidence is insufﬁcient to suggest optimal protocols. Nevertheless, repositioning is considered a practice with good face value, as added pressure to an area of vascular compromise will undoubtedly lead to a decrease in capillary blood ﬂow.
Negative Pressure Therapy (Level I)
Negative pressure devices have revolutionized wound healing in many respects. By reducing wound edema, decreasing the wound bioburden, and increasing local blood supply, these devices can help overcome traditional obstacles to ideal wound healing. However, the literature is inconclusive as to whether negative pressure therapy has an advantage for healing of pressure ulcers. Speciﬁcally, 2 randomized controlled studies examined negative pressure devices for pressure ulcers. One showed a reduction in ulcer volume using vacuum-assisted wound closure, whereas another showed equivocal results when compared with traditional dressings. More studies are clearly needed to deﬁne the role of this therapy in the temporizing treatment of pressure ulcers.
Debridement (Level III, IV)
There is much debate in the surgical literature as to which method of debridement is best. Typically, clinical experience and practice determine which forms of debridement are used. Debridement options for pressure ulcers can include biologic, autolytic, chemical, mechanical, and enzymatic debridement. Biologic debridement involves application of sterile larvae or maggots to the wound bed, which then remove the devitalized tissue. Autolytic debridement uses naturally occurring enzymes that dissolve sloughed tissue. Chemical debridement uses chemical compounds such as sodium hypochlorite (Dakin’s Solution) to enhance wound debridement. Mechanical debridement can encompass a variety of debridement techniques, including wet to dry dressings, wound cleansing, and whirlpool debridement. Enzymatic debridement uses preparations such as collagenase, papain, or urea over devitalized wound tissue. Unfortunately, although many studies have examined the efﬁcacy of one type of debridement over another, a recent Cochrane review demonstrated that there are no randomized controlled trials to support any one methods of debridement over another.
Enteral and Parental Feeding (Level II, III)
There is some evidence to support nutritional intervention in the form of enteral or parental feeding in aiding in pressure ulcer formation healing. A multicenter trial examining the effects of 2 daily oral supplemental drinks showed this intervention to signiﬁcantly lower the incidence of pressure ulcers and identiﬁed low serum albumin levels and lower limb fracture as independent risk factors. Another more recent paired cohort study examined serum markers for metabolism in patients with spinal cord injury with pressure sores and noted that the surgical correction of sores resolved the serologic abnormalities, such as in hemoglobin and serum protein. Therefore, it is reasonable to conclude that nutritional optimization has a beneﬁcial effect on pressure sore healing.
Vitamins and Minerals (Level I)
Although correcting vitamin deﬁciency was initially the focus on the role of vitamins in wound healing, recent research has shown that supplementation either orally or topically with vitamins has a positive effect on healing. Of the many vitamins and minerals implicated in wound healing, ascorbic acid (vitamin C) and zinc have been studied speciﬁcally for pressure sore healing. One double-blind randomized controlled trial of 88 patients with pressure sores showed a reduction in pressure sore area on application with 500 mg of ascorbic acid twice daily for 4 weeks. Another multicenter study showed that application of 500 mg of ascorbic acid twice daily for 12 weeks improved healing velocity. A double-blind randomized controlled trial studied the administration 200 mg of zinc sulfate 3 times daily for 24 weeks; this intervention failed to show any statistically signiﬁcant effects in ulcer healing. Therefore, it can be reasonably concluded that vitamin C, but not zinc, supplementation may have a positive effect on pressure ulcer healing.
Specialized Mattresses (Level I)
The use of specialized mattresses for patients with pressure ulcer is widespread in many hospitals. By reducing the quantity and duration of pressure between a patient and resting their surface, specialized mattresses have the ability to function in a similar manner to repositioning. Despite the high cost of these mattresses, they are still frequently used for patients with pressure ulcer, given their clear efﬁcacy. A recent Cochrane review identiﬁed 52 randomized control trials and concluded that patients at high risk for developing pressure ulcers should have specialized mattresses as opposed to regular hospital mattresses.
Ultrasound Therapy (Level I)
Ultrasound therapy has been proposed to have a therapeutic effect on wound healing. The literature suggests, however, that ultrasound therapy does not improve pressure ulcer healing. No signiﬁcant differences in healing were seen in 2 randomized controlled trials that compared ultrasound therapy with sham ultrasound therapy. Another study failed to show statistically signiﬁcant differences in healing between ultrasound/ultraviolet treatment and standard of care.
Honey (Level II)
Honey has been used for centuries as a wound-healing adjuvant. The mechanisms of action of honey in wound healing include antimicrobial activity, immunologic modulation, and physiologic mediation. Of the multitude of studies examining the use of honey in various wounds, one trial randomly assigned patient with pressure ulcers to receive either honey or saline-soaked dressings. This study found that the overall time to healing in days was less in the honey-treated group.
Cellular Therapy (Level IV)
Apligraf is a Food and Drug Administration–approved, living, bilayered cell therapy that has been shown to be efﬁcacious in a case study of patients with heel pressure ulcers (level IV). In this study, 10 patients were treated with Apligraf and pressure ofﬂoading. The patients in this study had ulcers for an average of 161.3 days before using Apligraf and subsequently achieved a mean time to complete ulcer healing of 44 days with therapy.
Musculocutaneous and Fasciocutaneous Flap Closure (Level III, IV, V)
The application of various ﬂaps to close debrided pressure ulcers has been studied in several case reports and series. Musculocutaneous and fasciocutaneous ﬂaps have been well described for reconstruction of pressure sores, as these ﬂaps provide vascularized tissue (Fig. 1). Tangentially split gluteus maximus myocutaneous ﬂaps have been used to reconstruct pressure sores while minimizing functional loss. A study of 30 patients showed excellent reconstructive outcomes with tangentially split myocutaneous gluteus perforator ﬂaps for pressure sore management without ﬂap loss and few complications. To further preserve the gluteal muscle, the superior gluteal artery perforator ﬂap and inferior gluteal artery perforator ﬂap have also been described and used with success for sacral, trochanteric, and ischial reconstruction. Local fasciocutaneous gluteal ﬂaps have also been used to reconstruct parapelvic pressure sores. The posterior-lateral thigh V-Y ﬂap has been shown to be a very effective option. Posterior thigh island ﬂaps have been used for trochanteric pressure sores and perforator ﬂaps have been used for perineal reconstruction.
Interestingly, a recent review of the literature of all of these ﬂaps performed for ischial pressure sores found an overall complication rate ranging from 0% to 80% and a recurrence rate from 0% to 33.3%. Unfortunately, given the uniqueness of each case including cause, age, and risk factors, it has been impossible to determine a hierarchy for ﬂap selection. Furthermore, there has been no study that has been able to compare the effectiveness of musculocutaneous and fasciocutaneous ﬂaps. It is important to note that, given the likelihood of recurrence, careful attention to patient selection and surgical planning is absolutely necessary.
Miscellaneous Modalities (Level IV, V)
Several other modalities of treatment or prevention of pressure ulcers exist in the literature supported only by studies with lower levels of evidence. Sitting protocols postoperatively are of unclear efﬁcacy, as demonstrated in a study of hospice patients. Ostectomy was shown in one small study to be an effective strategy to reduce the recurrence of pressure sores. Smoking and other comorbidities such as diabetes and peripheral vascular disease have been shown to be associated with an increased prevalence of pressure sores in a study of patients with spinal cord injury. Further large-scale, randomized trials are needed to completely understand the role of each of these factors in the pathophysiology and treatment/prevention of pressure sores.
Our own protocol for treating pressure ulcers attempts to take advantage of the modalities of care for which the highest level of evidence exist. All patients are seen and examined promptly. Nonspeciﬁc interventions including transfer to a specialized air mattress optimization of nutrition, and initiation of parenteral ascorbic acid (500 mg twice daily) are recommended immediately (although are usually in place already). Despite no high level of evidence to support its use, turning protocol every 2 hours are recommended as well (This intervention is also in place as a matter of hospital policy.) No further intervention except observation is initiated for stage I pressure sores. Wound cleansers are recommended in the form of saline spray that contains aloe, silver chloride, or decyl glucoside for stage 2 pressure ulcers. Stage 3 and 4 pressure ulcers almost always undergo sharp excisional debridement, either at the bedside (if insensate) or in the operating room. Enzymatic debridement is sometimes used, although little is expected beyond removal of superﬁcial necrotic tissue. Infected wounds suggestive of causing systemic illness always undergo sharp debridement and tissue is sent for routine culture and pathology. Excisional debridement in patients who do not demonstrate an ability to heal a wound is deferred to avoid increasing the size and burden of the pressure sore. Flap surgery is usually reserved for patients whose social situations (ie, living arrangements, care providers, medical conditions, access to health care, etc) have changed since developing their pressure sore. We prefer using fasciocutaenous ﬂaps in ambulatory patients to minimize potential morbidity. Perforator ﬂaps are also reserved for ambulatory patients because of their limited ability for readvancement.
Table 3 summarizes the current modalities in pressure ulcer management and the respective levels of evidence that exist and current evidence-based clinical effectiveness. Figure 4 gives a representation of the pathophysiology of pressure ulcer formation and where each preventative or therapeutic modality is thought to intervene. These modalities for treatment and prevention have become focal points of several major organizations aiming to better manage pressure ulcers. For instance, the National Quality Forum have identiﬁed pressure ulcers as a target to improve health care of American people and has created a framework for measuring quality for prevention and management of pressure sores. Centers for Medicare & Medicaid have also described pressure ulcers as a hospital-acquired condition and are thus particularly interested in their diagnosis and management. Accordingly, the American College of Surgeons and American Society of Plastic Surgeons have made pressure ulcers their purview; however, none of these organizations have endorsed a clinical management algorithm, likely secondary to the varying levels of evidence surrounding the many modalities of therapy. Whatever the approach to treating these complex clinical problems may be, we encourage clinicians and health care providers to consider the evidence based data when deciding how to most appropriately manage their own patient’s pressure sores.