Soft silicone foam dressing is more effective than polyurethane film dressing for preventing intraoperatively acquired pressure ulcers in spinal surgery patients: the Border Operating room Spinal Surgery (<scp>BOSS</scp>) trial in Japan

Yoshimura, Mine; Ohura, Norihiko; Tanaka, Junko; Ichimura, Shoichi; Kasuya, Yuko; Hotta, Oruto; Kagaya, Yu; Sekiyama, Takuya; Tannba, Mitsuko; Suzuki, Nao

doi:10.1111/iwj.12696

Cited by 45 publications

(62 citation statements)

References 38 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Since the company submitted its report, a full publication became available for the unpublished trial [14]. Twenty-two observational studies, including 14 published [15–28] and 8 unpublished [29–36]. Seven published systematic reviews [37–40].…”

Section: Review Of Clinical and Economic Evidencementioning

confidence: 99%

See 1 more Smart Citation

Mepilex Border Sacrum and Heel Dressings for the Prevention of Pressure Ulcers: A NICE Medical Technology Guidance

Marshall

Shore

Arber

et al. 2019

Appl Health Econ Health Policy

View full text Add to dashboard Cite

Mepilex Border Sacrum and Heel dressings are self-adherent, multilayer foam dressings designed for use on the heel and sacrum aiming to prevent pressure ulcers. The dressings are used in addition to standard care protocols for pressure ulcer prevention. The National Institute for Health and Care Excellence (NICE) selected Mepilex Border Sacrum and Heel dressings for evaluation. The External Assessment Centre (EAC) critiqued the company’s submission. Thirteen studies (four randomised controlled trials and nine nonrandomised comparative studies) were included. The majority of studies compared Mepilex Border Sacrum dressings (plus standard care) with standard care alone. Comparative evidence for Mepilex Border Heel dressings was limited. A meta-analysis indicated a non-statistically significant difference in favour of Mepilex Border Sacrum dressings for pressure ulcer incidence [RR 0.51 (95% CI 0.22–1.18)]. The company produced a de novo cost model, which was critiqued by the EAC. After the EAC updated input parameters, cost savings of £19 per patient compared with standard care alone for pressure ulcer prevention were estimated with Mepilex Border dressings predicted to be cost saving in 57% of iterations. The Medical Technologies Advisory Committee reviewed the evidence and judged that, although Mepilex Border Heel and Sacrum dressings have potential to prevent pressure ulcers in people who are considered to be at risk in acute care settings, further evidence is required to address uncertainties around the claimed benefits of the dressings and the incidence of pressure ulcers in an NHS acute-care setting. After a public consultation, NICE published this as Medical Technology Guidance 40.

show abstract

Section: Review Of Clinical and Economic Evidencementioning

confidence: 99%

“…Three of which were identified and included by the company [10, 11, 13] and one newly identified by the EAC [42]. Nine comparative observational studies [17–19, 23–25, 28, 33, 36]. All of these studies were identified and included by the company.…”

Section: Review Of Clinical and Economic Evidencementioning

confidence: 99%

Mepilex Border Sacrum and Heel Dressings for the Prevention of Pressure Ulcers: A NICE Medical Technology Guidance

Marshall

Shore

Arber

et al. 2019

Appl Health Econ Health Policy

View full text Add to dashboard Cite

show abstract

“…The duration of surgery is a well-known risk factor for ulcers. [4,7,[14][15][16] A study conducted across multiple departments reported that the mean length of surgery for patients who developed ulcers was 234 min [4].…”

Section: Discussionmentioning

confidence: 99%

“…Their frequency ranges from 2.5 to 66%, [3][4][5][6][7] and their incidence is high in orthopedic surgeries (up to 11.8%) [6]. Other factors associated with ulcers include age, [8][9][10] sex, [9,10] low Braden scale score, [9,11,12] low body mass index (BMI), [7,12] diabetes, [13] duration of surgery, [4,7,[14][15][16] surgical positioning (prone and park-bench position), [7,16] application of external force, [7] and the amount of blood loss [7]. In addition, medical device-related pressure ulcers defined as resulting from the use of devices designed and applied for diagnostic or therapeutic purposes [9] have been reported to be increased owing to the development of technology and the increased use of medical devices for patients [17].…”

Section: Introductionmentioning

confidence: 99%

Risk factors for pressure ulcers from the use of a pelvic positioner in hip surgery: a retrospective observational cohort study in 229 patients

et al. 2020

View full text Add to dashboard Cite

Background: Intraoperatively acquired pressure ulcers are serious postsurgical complications requiring additional treatment, reoperation, and extended hospitalization. No study has investigated the frequency of the ulcers caused by compression with a pelvic positioner, which is used in hip surgeries to stabilize patients in the lateral decubitus position. Methods: This retrospective study investigated the risk factors and the frequency of the ulcers caused by the use of pelvic positioners in hip surgeries. The records of patients who underwent surgical procedures under general anesthesia at our institution between January 1, 2016 and March 31, 2018 were reviewed. The inclusion criterion for the assessment of risk factors was hip surgery in the lateral decubitus position stabilized by a pelvic positioner. The exclusion criteria were patients with trauma, missing data, or a pre-existing pressure ulcer. Finally,.the study included 229 patients (265 hip surgeries). All the patients were positioned in the lateral decubitus position with the assistance of either a pelvic positioner, which had a single support fixture located over the pubic symphysis or a double support fixture located over the bilateral anterior superior iliac spine. Intraoperatively acquired pressure ulcers were diagnosed when ulcers were absent on admission and the redness that was observed immediately after surgery remained after 24 h. Multivariate analysis was used to identify factors associated with an increased risk for ulcers. Results: Ulcers developed in 8 of 1810 (0.44%) patients who underwent orthopedic surgery. Seven of the 265 (2.64%) patients who underwent hip surgery in the lateral decubitus position stabilized by a pelvic positioner developed ulcers. All ulcers were located on areas of the body that were compressed by the pelvic positioner. After identifying controls for patient height (less than 154 cm), surgery duration (longer than 180 min), blood loss (more than 355 ml), and type of pelvic positioner used, we identified the independent risk factors for ulcers to be patient height < 154 cm (adjusted odds ratio, 12.8; p-value, 0.032) and the use of pelvic positioners with pubic bone support (adjusted odds ratio, 10.53; p-value, 0.047). Conclusion: The use of pelvic positioners with pubic bone support should be avoided in patients with a height of < 154 cm to decrease the risk of ulcers.

show abstract

“…A randomized controlled trial conducted in the USA reported that the use of a soft silicone foam dressing combined with standard preventive care provided a statistically and clinically significant benefit in reducing incidence and severity of hospital acquired pressure injuries (HAPIs) in intensive care patients when compared to patients who received standard preventive care (Kalowes et al, 2016). A prospective dual-center sham study conducted in Japan that involved patients undergoing elective spinal surgery reported that soft silicone foam dressing was more effective than p o l y u r e t ha n e fi lm dressing for t he prevention of intraoperatively acquired pressure injuries (IAPIs) (Yoshimura et al, 2018). A randomized controlled trial of clinical effectiveness of multi-layer silicone foam dressings used for the prevention of pressure injuries in high-risk aged care residents in Australia reported that the use of the Mölnlycke Mepilex Border Sacrum and Mepilex Heel dressings offered a significant additional protective benefit to the participants in this population group (Santamaria et al, Main properties and related advantages:…”

Section: Evidence Of Effectivenessmentioning

confidence: 99%

First-Line Interactive Wound Dressing Update: A Comprehensive Review of the Evidence

2020

View full text Add to dashboard Cite

Wound management is a significant and growing issue worldwide. Knowledge of dressing products and clinical expertise in dressing selection are two major components in holistic wound management to ensure evidence-based wound care. With expanding global market of dressing products, there is need to update clinician knowledge of dressing properties in wound care. Optimal wound management depends on accurate patient assessment, wound diagnosis, clinicians' knowledge of the wound healing process and properties of wound dressings. We conducted a comprehensive review of the physical properties of wound dressing products, including the advantages and disadvantages, indications and contraindications and effectiveness of first-line interactive/bioactive dressing groups commonly used in clinical practice. These include semipermeable films, foams, hydroactives, alginates, hydrofibers, hydrocolloids, and hydrogels. In making decisions regarding dressing product selection, clinicians need to ensure a holistic assessment of patient and wound etiology, and understand dressing properties when making clinical decisions using wound management guidelines to ensure optimal patient outcomes. This review has highlighted there is lack of high quality evidence and the need for future well designed trials.

show abstract

Soft silicone foam dressing is more effective than polyurethane film dressing for preventing intraoperatively acquired pressure ulcers in spinal surgery patients: the Border Operating room Spinal Surgery (BOSS) trial in Japan

Cited by 45 publications

References 38 publications

Mepilex Border Sacrum and Heel Dressings for the Prevention of Pressure Ulcers: A NICE Medical Technology Guidance

Mepilex Border Sacrum and Heel Dressings for the Prevention of Pressure Ulcers: A NICE Medical Technology Guidance

Risk factors for pressure ulcers from the use of a pelvic positioner in hip surgery: a retrospective observational cohort study in 229 patients

First-Line Interactive Wound Dressing Update: A Comprehensive Review of the Evidence

Contact Info

Product

Resources

About