N/A
Completed N=40
Clinical Study to Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds
Source: ClinicalTrials.gov NCT03662997 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcomePrimary: % of Participants With Equal or Better Rate of Dressing Durability — 100.0; 94.1; 69.2; 73.3 %participants — p=0.046
Summary
A prospective, randomized, controlled clinical trial (RCT) using a cross-over (repeated measures) design to evaluate safety and efficacy of three foam wound dressings in the local management of chronic wounds.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY % of Participants With Equal or Better Rate of Dressing Durability |
100.0; 94.1; 69.2; 73.3 | 0.046 sig |
| PRIMARY % of Participants With No Strike-through After 7 Days Wear Time at Day 7 and 21 |
43.8; 35.3; 12.5; 5.6 | 0.046 sig |
| SECONDARY % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Before Dressing Removal With Five-layer |
92.3; 75.1; 100.0; 83.4 | — |
| SECONDARY % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain at Removal With Five-layer |
69.3; 87.6; 100.0; 58.3 | — |
| SECONDARY % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Immediately After Dressing Removal With Five-layer |
77.0; 81.3; 90.9; 58.4 | — |
| SECONDARY % of Participants With Equal or Better Outcomes With Five-layer in Evaluation of the Dressings |
100.0; 70.6; 84.6; 73.3 | — |
| SECONDARY % of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wound Granulation |
92.3; 93.8; 81.8; 66.7 | — |
| SECONDARY % of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wounds for Non-viable Tissue (Eschar, Fibrin Slough, Both) |
100.0; 93.8; 90.9; 91.6 | — |
| SECONDARY Mean Difference in Score in SF12 Health-Related Quality-of-Life Questionnaire |
-0.896; -3.13; 1.99; 0.001; -6.57; 5.11 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female subjects 18-85 years of age with leg and foot ulcers (i.e. VLU, DFU).
- Signed informed consent.
- Subject and/or caregiver must be willing and able to tolerate multi-layered compression bandages when applicable and offloading footwear.
- Study subject must be available and able to visit the clinic weekly for the full 4-week period.
Exclusion Criteria
- Pressure ulcers should not be included. Pressure injury as defined by the National Pressure Ulcer Advisory Panel (NPUAP).
- Presence of local wound infection as determined by study doctor based on clinical signs and symptoms.
- Subject has any evidence of peripheral arterial disease (PAD).
- Subject diagnosed with malignancy other than cutaneous basal cell carcinoma.
- Subject has received growth factor therapy (e.g. autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix e.g. amnion, amniotic tissue) within 2 weeks of screening date.
- Pregnancy or lactation at time of study participation.
- Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization.
- Subject is currently enrolled or participated in another investigational device, drug or biological trial within 30 days of baseline of this study.
- Present history of alcohol or drug abuse.
- Known allergy/hypersensitivity to any of the components of the dressing.
- Subject not suitable for the investigation according to the investigator's judgment.
Data sourced from ClinicalTrials.gov (NCT03662997). 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. Informational only — not medical advice.