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Wound Management for Sacral Pressure Ulcers With Necrotic Tissue

M

Medline Industries

Status and phase

Completed
Phase 4

Conditions

Pressure Ulcers

Treatments

Device: TheraHoney HD
Device: SkinTegrity

Study type

Interventional

Funder types

Industry

Identifiers

NCT02224638
R14-028

Details and patient eligibility

About

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

Full description

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.

Enrollment

21 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 3rd degree burns
  • know hypersensitivity to products

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

21 participants in 2 patient groups

TheraHoney HD
Active Comparator group
Description:
Honey product
Treatment:
Device: TheraHoney HD
SkinTegrity
Active Comparator group
Description:
Skin moisturizer
Treatment:
Device: SkinTegrity

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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