P400 for Stage II-IV Pressure Ulcers in Home and Extended Care

NCT01139879 | Completed Results

• 1 other identifier: CR-0092
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the efficacy of a pressure ulcer treatment mattress, the P400 mattress, in the treatment of multiple Stage II or one or more large Stage III or IV pressure ulcers in the home care and extended care (nursing home) environment.

Conditions

Pressure Ulcers

Keywords

Pressure Ulcer treatment Mattresses; Home Care; Extended Care; Wound measurements

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Ulcer Surface Area at Week 12

  The primary outcome measure for this study is to be healing rate by area, based on the identified target study ulcer.

  12 Weeks

Secondary Outcomes (2)

• Incidence of New Ulcers

  12 Weeks

• Healing Rate Per Week

  12 weeks

Study Arms (1)

P400 support surface

EXPERIMENTAL

All patients will receive the P400 mattress

Device: P400 mattress

Interventions

P400 mattress DEVICE

The P400 mattress will be placed for a period of 12 weeks.

P400 support surface

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has multiple Stage II pressure ulcers or at least one Stage III or IV pressure ulcer(s) (as per National Pressure Ulcer Advisory Panel Staging guidelines) located either on the trunk or pelvis (which would include trochanter and ischial ulcers ) having a clean wound bed of less than or equal to 25% necrotic tissue at the base of the pressure ulcer.
• Subjects may have heel ulcers, however these ulcers may not be considered a target study ulcer.
• Subject, or legally authorized representative is able to provide informed consent
• Subject weighs between 70 and 350 pounds
• Subject's nutritional status is thought to be adequate to support wound healing
• Subject qualifies for a Group 2 support surface (Target study ulcer must be at least 8 cm\^2 in area to qualify)

You may not qualify if:

• Subject's target ulcer is unstageable due to eschar or necrosis or a suspected Deep Tissue Injury may be located at the base of the wound.
• Subject has unresolved systemic infection, or pressure ulcer infection, or a history of osteomyelitis, or greater than 25% eschar or necrotic tissue present in the wound bed.
• Patient has already been enrolled in this study
• Patient has a recent history of non-compliance with pressure ulcer offloading, repositioning, or other areas of the treatment care plan, which would jeopardize wound healing if continued.
• Care plan goals are palliative

Sponsors & Collaborators

• Hill-Rom: lead

Study Sites (1)

Southwest Regional Wound Care Center

Lubbock, Texas, 79410, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Small study with no comparative arm.

Results Point of Contact

• Title: Randy Wolcott
• Organization: Wolcott and Associates

lisa@randallwolcott.com

806-793-8869

Study Officials

• Randall Wolcott, MD

  Randall Wolcott and Assoiciates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 9, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 17, 2015
• Results First Posted: December 17, 2015

Record last verified: 2015-11

Locations

US (1)