Trial Outcomes & Findings for Wound Management for Sacral Pressure Ulcers With Necrotic Tissue (NCT NCT02224638)

NCT ID: NCT02224638

Last Updated: 2019-07-24

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 21 participants
• Primary outcome timeframe: 3 weeks
• Results posted on: 2019-07-24

Participant Flow

Participant milestones

Measure	SkinTegrity Skin moisturizer SkinTegrity: Hydrogel	TheraHoney HD Honey product TheraHoney HD: Honey
Overall Study STARTED	10	11
Overall Study COMPLETED	9	10
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	SkinTegrity Skin moisturizer SkinTegrity: Hydrogel	TheraHoney HD Honey product TheraHoney HD: Honey
Overall Study Adverse Event	1	1

Baseline Characteristics

Wound Management for Sacral Pressure Ulcers With Necrotic Tissue

Baseline characteristics by cohort

Measure	TheraHoney HD n=11 Participants Honey product TheraHoney HD: Honey	SkinTegrity n=10 Participants Skin moisturizer SkinTegrity: Hydrogel	Total n=21 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks

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

Outcome measures

Measure	TheraHoney HD n=11 Participants Honey product	SkinTegrity n=10 Participants SkinTegrity: Hydrogel
Percentage of Wounds Healed	63.1 percentage of wounds Standard Deviation 38.4	6.1 percentage of wounds Standard Deviation 74.7

SECONDARY outcome

Timeframe: 3 weeks

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

Outcome measures

Measure	TheraHoney HD n=11 Participants Honey product	SkinTegrity n=10 Participants SkinTegrity: Hydrogel
Number of Participants With Adverse Events	1 Participants	2 Participants

Adverse Events

TheraHoney HD

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

SkinTegrity

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	TheraHoney HD n=11 participants at risk Honey product TheraHoney HD: Honey	SkinTegrity n=10 participants at risk Skin moisturizer SkinTegrity: Hydrogel
Infections and infestations Infection/sepsis	0.00% 0/11 • wound treatment period of 34 days	10.0% 1/10 • Number of events 1 • wound treatment period of 34 days
Gastrointestinal disorders Ischemic Bowel Surgery	9.1% 1/11 • Number of events 1 • wound treatment period of 34 days	0.00% 0/10 • wound treatment period of 34 days
Cardiac disorders AFIB	0.00% 0/11 • wound treatment period of 34 days	10.0% 1/10 • Number of events 1 • wound treatment period of 34 days

Other adverse events

Measure	TheraHoney HD n=11 participants at risk Honey product TheraHoney HD: Honey	SkinTegrity n=10 participants at risk Skin moisturizer SkinTegrity: Hydrogel
Musculoskeletal and connective tissue disorders Periwound Maceration	9.1% 1/11 • Number of events 1 • wound treatment period of 34 days	0.00% 0/10 • wound treatment period of 34 days
Musculoskeletal and connective tissue disorders Increased Wound Size	0.00% 0/11 • wound treatment period of 34 days	10.0% 1/10 • Number of events 1 • wound treatment period of 34 days

Additional Information

Nancy Chaiken

Swedish Covenant Hospital

Phone: 847-372-3500

Email: nchaiken@comcast.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place