Phase 4 N=21 Randomized Treatment

Wound Management for Sacral Pressure Ulcers With Necrotic Tissue

Pressure Ulcers

Bottom Line

View on ClinicalTrials.gov: NCT02224638 ↗

Enrolled (actual)

Serious AEs

14.3%

Results posted

Nov 2018

Primary outcome: Primary: Percentage of Wounds Healed — 63.1; 6.1 percentage of wounds

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: TheraHoney HD (Device); SkinTegrity (Device)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Medline Industries
Primary completion: Aug 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Wounds Healed	63.1; 6.1	—
SECONDARY Number of Participants With Adverse Events	1; 2	—

Summary

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

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

3rd degree burns
know hypersensitivity to products

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02224638). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.