Clinical Trials Logo
  1. Home
  2. Pressure Ulcers
  3. NCT02224638
  4. Details
NCT02224638 Clinical Trial

Wound Management for Sacral Pressure Ulcers With Necrotic Tissue

Pressure Ulcers Clinical Trial

Official title:
Evaluation of Wound Management for Sacral Pressure Ulcers With Necrotic Tissue

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02224638
Other study ID # R14-028
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 2014
Est. completion date August 2015

Study information
Verified date July 2019
Source Medline Industries
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluation of a wound care debridement product and a moisturizer on sacral pressure ulcer wounds

Description:

Pressure ulcers on the sacral area will be applied with either a wound debridement product or a wound moisturizer product plus a gentle wound dressing to manage wound closure over a 2-3 week period of treatment.

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Male or female subjects of any age

- Sacral wounds with necrotic tissue

Exclusion Criteria:

- 3rd degree burns

- know hypersensitivity to products

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• TheraHoney HD
Honey
• SkinTegrity
Hydrogel

Locations
Country Name City State
United States Harmony Residential Facility Chicago Illinois
United States Swedish Covenant Hospital Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
Medline Industries

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Wounds Healed Percentage of wounds that were complete or partially healed with either treatment measured by change in wound size of sacral pressure ulcer 3 weeks
Secondary Number of Participants With Adverse Events Adverse events related to the presence or absence of wound infections and worsening in ulcer staging. 3 weeks
See also
  Status Clinical Trial Phase
Completed NCT02930590 - Effects of Different Support Surfaces on the Properties Skin After Loading N/A
Completed NCT02224404 - Post Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended N/A
Completed NCT01965444 - A Test of the Investigational SEM Scanner N/A
Withdrawn NCT00623948 - Implanted Gluteal Stimulation System for Pressure Sore Prevention N/A
Terminated NCT01433159 - Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury Phase 2
Recruiting NCT01355666 - Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting N/A
Completed NCT01403272 - Evaluate the Efficacy of a Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting N/A
Completed NCT01008254 - Interdisciplinary Mobility Approach To Reduction Of Facility-Acquired Pressure Ulcers Phase 2/Phase 3
Completed NCT00971048 - Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds N/A
Terminated NCT00762138 - The AutoloGel™ Post-Market Surveillance (TAPS) Program N/A
Completed NCT00507650 - Increasing Fluids in Older Adults to Prevent & Treat Pressure Ulcers N/A
Completed NCT01877681 - Reference Nurse Program for Pressure Ulcers in Primary Care Phase 2
Completed NCT01232764 - Pressure Ulcer Multi-disciplinary Teams Via Telemedicine (PUMTT): A Trial in Long Term Care Phase 3
Completed NCT06374563 - Tackling Pressure Ulcer Via Bee Venom Phonophoresis N/A
Completed NCT03070925 - Prospective PuraPly™ AM Case Series Study N/A
Completed NCT02894437 - Qualitative Study of Preventive Organization of the Pelvic Bedsores Injured Spinal Cord
Completed NCT01348581 - Use of Fish Skin Extracellular Matrix (ECM) to Facilitate Chronic Wound Healing N/A
Completed NCT00763282 - Self-Management to Prevent Ulcers in Veterans With SCI (Spinal Cord Injury) N/A
Completed NCT00771238 - Pilot Study of Incidence and Change in Existing Pressure Ulcers: TC500 Bed Compared With Standard Beds N/A
Completed NCT01885962 - Development and Feasibility of an Internet Intervention for Adults With Spinal Cord Injury to Prevent Pressure Ulcers N/A