NCT02689817

Brief Summary

Hospital-acquired pressure ulcers (HAPUs) are a well-established serious complication of hospitalization that have serious consequences on patient morbidity and mortality as well as the cost of care. At the core of the problem for patient-centered targeted prevention of HAPUs is the lack of knowledge surrounding the magnitude and duration of pressure necessary to cause pressure ulcers, and the lack of immediate feedback on whether these interventions do anything to substantially offload at risk areas. Previous studies have been inconsistent in their findings of an association between duration of time and HAPU occurrence. While retrospectively this has been investigated, there is currently no substantial prospective, randomized study. This study seeks to better understand the interface pressures between the patient and his or her support surface and how this relates to the development of pressure ulcers. The effect of patient characteristics and the relationship between total length of time on the operating table and pressure ulcer development will also be assessed. The findings from this study will significantly add to strengthening the body of evidence regarding pressure ulcer development, specifically the relationship between the magnitude of interface pressure between the patient and the support surface for what duration of time leads to the development of a pressure ulcer. The results will provide critical insight into the physiologic targets healthcare providers should use to develop better pressure ulcer prevention programs, which could ultimately lead to a reduction in the incidence of pressure ulcers.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 16, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
3.6 years until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

November 4, 2019

Status Verified

October 1, 2019

Enrollment Period

Same day

First QC Date

February 16, 2016

Last Update Submit

October 31, 2019

Conditions

Pressure UlcerSigns and Symptoms

Keywords

Pressure ulcerMonitoringPressurePhysiologic feedback

Outcome Measures

Primary Outcomes (1)

  • Interface pressure (mmHg) over time (minutes)

    The interface pressure trend on the sacrum throughout the duration of time a patient is on the operating table and how that is correlated with pressure ulcer development

    Duration of the surgery (>120 min, <1440 min)

Secondary Outcomes (7)

  • Pressure ulcer development

    1 week

  • Effect of Braden Scale

    1 week

  • Effect of Body Weight (kg)

    1 week

  • Effect of Body Mass Index (kg/m^2)

    1 week

  • Effect of Age (years)

    1 week

  • +2 more secondary outcomes

Study Arms (1)

Monitoring patch, no display

EXPERIMENTAL

Participants in this condition will receive a padded bandage that monitors pressure over time. In this arm, healthcare providers will not be able to view the pressure data collected.

Device: Patch

Interventions

PatchDEVICE

A bandage applied to the sacrum with pressure offloading characteristics and pressure monitoring components in a low-profile housing.

Monitoring patch, no display

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing an operation that is scheduled to last more than 2 hours

You may not qualify if:

  • Existing sacral pressure ulcer, undergoing a cardiac procedure, or inability to provide informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (18)

  • Berlowitz D, VanDeusen Lukas C, Parker V, Niederhauser A, Silver J, Logan C, Ayello E, Zulkowski K. 2012. Preventing Pressure Ulcers in Hospitals: A Toolkit for Improving Quality of Care. Rockville, MD: Agency for Healthcare Research and Quality; 2011. Rockville, MD: Agency for Healthcare Research and Quality.

    BACKGROUND

  • Black JM, Edsberg LE, Baharestani MM, Langemo D, Goldberg M, McNichol L, Cuddigan J; National Pressure Ulcer Advisory Panel. Pressure ulcers: avoidable or unavoidable? Results of the National Pressure Ulcer Advisory Panel Consensus Conference. Ostomy Wound Manage. 2011 Feb;57(2):24-37.

    PMID: 21350270BACKGROUND

  • Feil M BJ. 2015. Hospital-Acquired Pressure Ulcers Remain a Top Patient Safety Concern for Hospitals in Pennsylvania. :1-10.

    BACKGROUND

  • Gillespie BM, Chaboyer WP, McInnes E, Kent B, Whitty JA, Thalib L. Repositioning for pressure ulcer prevention in adults. Cochrane Database Syst Rev. 2014 Apr 3;2014(4):CD009958. doi: 10.1002/14651858.CD009958.pub2.

    PMID: 24700291BACKGROUND

  • Hommel A, Bjorkelund KB, Thorngren KG, Ulander K. Nutritional status among patients with hip fracture in relation to pressure ulcers. Clin Nutr. 2007 Oct;26(5):589-96. doi: 10.1016/j.clnu.2007.06.003. Epub 2007 Jul 26.

    PMID: 17662510BACKGROUND

  • Houwing R, Rozendaal M, Wouters-Wesseling W, Buskens E, Keller P, Haalboom J. Pressure ulcer risk in hip fracture patients. Acta Orthop Scand. 2004 Aug;75(4):390-3. doi: 10.1080/00016470410001132-1.

    PMID: 15370580BACKGROUND

  • KOSIAK M. Etiology and pathology of ischemic ulcers. Arch Phys Med Rehabil. 1959 Feb;40(2):62-9. No abstract available.

    PMID: 13618101BACKGROUND

  • KOSIAK M. Etiology of decubitus ulcers. Arch Phys Med Rehabil. 1961 Jan;42:19-29. No abstract available.

    PMID: 13753341BACKGROUND

  • Lindholm C, Sterner E, Romanelli M, Pina E, Torra y Bou J, Hietanen H, Iivanainen A, Gunningberg L, Hommel A, Klang B, Dealey C. Hip fracture and pressure ulcers - the Pan-European Pressure Ulcer Study - intrinsic and extrinsic risk factors. Int Wound J. 2008 Jun;5(2):315-28. doi: 10.1111/j.1742-481X.2008.00452.x.

    PMID: 18494637BACKGROUND

  • McInnes E, Jammali-Blasi A, Bell-Syer SE, Dumville JC, Middleton V, Cullum N. Support surfaces for pressure ulcer prevention. Cochrane Database Syst Rev. 2015 Sep 3;2015(9):CD001735. doi: 10.1002/14651858.CD001735.pub5.

    PMID: 26333288BACKGROUND

  • Meddings J. Using administrative discharge diagnoses to track hospital-acquired pressure ulcer incidence--limitations, links, and leaps. Jt Comm J Qual Patient Saf. 2015 Jun;41(6):243-5. doi: 10.1016/s1553-7250(15)41033-5. No abstract available.

    PMID: 25990889BACKGROUND

  • Padula WV, Makic MB, Mishra MK, Campbell JD, Nair KV, Wald HL, Valuck RJ. Comparative effectiveness of quality improvement interventions for pressure ulcer prevention in academic medical centers in the United States. Jt Comm J Qual Patient Saf. 2015 Jun;41(6):246-56. doi: 10.1016/s1553-7250(15)41034-7.

    PMID: 25990890BACKGROUND

  • Padula WV, Makic MB, Wald HL, Campbell JD, Nair KV, Mishra MK, Valuck RJ. Hospital-Acquired Pressure Ulcers at Academic Medical Centers in the United States, 2008-2012: Tracking Changes Since the CMS Nonpayment Policy. Jt Comm J Qual Patient Saf. 2015 Jun;41(6):257-63. doi: 10.1016/s1553-7250(15)41035-9.

    PMID: 25990891BACKGROUND

  • Peich S, Calderon-Margalit R. Reduction of nosocomial pressure ulcers in patients with hip fractures: a quality improvement program. Int J Health Care Qual Assur Inc Leadersh Health Serv. 2004;17(2-3):75-80. doi: 10.1108/09526860410526682.

    PMID: 15301263BACKGROUND

  • Qaseem A, Mir TP, Starkey M, Denberg TD; Clinical Guidelines Committee of the American College of Physicians. Risk assessment and prevention of pressure ulcers: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2015 Mar 3;162(5):359-69. doi: 10.7326/M14-1567.

    PMID: 25732278BACKGROUND

  • Ratliff CR; WOCN. WOCN's evidence-based pressure ulcer guideline. Adv Skin Wound Care. 2005 May;18(4):204-8. doi: 10.1097/00129334-200505000-00009. No abstract available.

    PMID: 15920372BACKGROUND

  • Reddy M, Gill SS, Rochon PA. Preventing pressure ulcers: a systematic review. JAMA. 2006 Aug 23;296(8):974-84. doi: 10.1001/jama.296.8.974.

    PMID: 16926357BACKGROUND

  • VanGilder C, Amlung S, Harrison P, Meyer S. Results of the 2008-2009 International Pressure Ulcer Prevalence Survey and a 3-year, acute care, unit-specific analysis. Ostomy Wound Manage. 2009 Nov 1;55(11):39-45.

    PMID: 19934462BACKGROUND

MeSH Terms

Conditions

Pressure UlcerSigns and Symptoms

Interventions

Transdermal Patch

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Justin Sacks, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The investigator and outcomes assessors will be masked to the pressure data during the operating room and follow-up.
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2016

First Posted

February 24, 2016

Study Start

October 1, 2019

Primary Completion

October 1, 2019

Study Completion

January 1, 2020

Last Updated

November 4, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share