NCT02224638

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

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

August 20, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 25, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

November 7, 2018

Completed
Last Updated

July 24, 2019

Status Verified

July 1, 2019

Enrollment Period

8 months

First QC Date

August 20, 2014

Results QC Date

August 29, 2017

Last Update Submit

July 15, 2019

Conditions

Pressure Ulcers

Keywords

skin ulcers

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Number of Participants With Adverse Events

    3 weeks

Study Arms (2)

TheraHoney HD

ACTIVE COMPARATOR

Honey product

Device: TheraHoney HD

SkinTegrity

ACTIVE COMPARATOR

Skin moisturizer

Device: SkinTegrity

Interventions

TheraHoney HDDEVICE

Honey

TheraHoney HD
SkinTegrityDEVICE

Hydrogel

Also known as: Hydrogel
SkinTegrity

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • rd degree burns
  • know hypersensitivity to products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Swedish Covenant Hospital

Chicago, Illinois, 606025, United States

Location

Harmony Residential Facility

Chicago, Illinois, 60625, United States

Location

MeSH Terms

Conditions

Pressure UlcerSkin Ulcer

Interventions

Bandages, Hydrocolloid

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BandagesEquipment and Supplies

Results Point of Contact

Title
Nancy Chaiken
Organization
Swedish Covenant Hospital
nchaiken@comcast.net
847-372-3500

Study Officials

  • Nancy Chaiken, RN

    Swedish Covenant Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2014

First Posted

August 25, 2014

Study Start

December 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

July 24, 2019

Results First Posted

November 7, 2018

Record last verified: 2019-07

Locations

US(2)