Wound Management for Sacral Pressure Ulcers With Necrotic Tissue

NCT ID: NCT02224638

Last Updated: 2019-07-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pressure Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A single-center, randomized open-label study with multiple application treatment of necrotic sacral or buttocks pressure ulcers with either TheraHoney HD or SkinTegrity Hydrogel.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TheraHoney HD

Honey product

Group Type ACTIVE_COMPARATOR

TheraHoney HD

Intervention Type DEVICE

Honey

SkinTegrity

Skin moisturizer

Group Type ACTIVE_COMPARATOR

SkinTegrity

Intervention Type DEVICE

Hydrogel

Interventions

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TheraHoney HD

Honey

Intervention Type DEVICE

SkinTegrity

Hydrogel

Intervention Type DEVICE

Other Intervention Names

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Hydrogel

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 3rd degree burns
* know hypersensitivity to products
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medline Industries

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nancy Chaiken, RN

Role: PRINCIPAL_INVESTIGATOR

Swedish Covenant Hospital

Locations

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Swedish Covenant Hospital

Chicago, Illinois, United States

Site Status

Harmony Residential Facility

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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R14-028

Identifier Type: -

Identifier Source: org_study_id

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