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OpenTrials
Completed

NCT Number: NCT02224638

Wound Management for Sacral Pressure Ulcers With Necrotic Tissue

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

Completed

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Key information

Conditions

Pressure Ulcers Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Harmony Residential Facility, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subjects of any age
  • Sacral wounds with necrotic tissue

Exclusion criteria

  • 3rd degree burns
  • know hypersensitivity to products

Treatment and study plan

TheraHoney HD

Device

Honey

SkinTegrity

Device

Hydrogel

Other names: Hydrogel

Primary outcomes

  1. Percentage of Wounds Healed

    Time frame: 3 weeks

    Percentage of wounds that were complete or partially healed with either treatment measured by change in wound size of sacral pressure ulcer

Secondary outcomes

  1. Number of Participants With Adverse Events

    Time frame: 3 weeks

    Adverse events related to the presence or absence of wound infections and worsening in ulcer staging.

Sponsors and collaborators

Lead sponsor

Medline Industries

Industry

Registry information

Official study title

Evaluation of Wound Management for Sacral Pressure Ulcers With Necrotic Tissue

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 25, 2014
Registry last updated
Jul 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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