N/A
Completed N=109
Evaluation of Exufiber Ag+ and Other Gelling Fibre Dressings
Wounds and Injuries
Source: ClinicalTrials.gov NCT03249909 ↗
Enrolled (actual)
109
Serious AEs
7.3%
Results posted
Sep 2020
Primary outcomePrimary: Change in Exudate Status From Baseline to Last Visit — 27; 3; 7; 40 Participants — p=0.0019
Summary
Investigate impact of gelling fiber dressings on handling exudate in medium to high exuding wounds
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Exudate Status From Baseline to Last Visit |
27; 3; 7; 40; 6; 8 | 0.0019 sig |
| SECONDARY 4-Week Wound Status |
2; 1; 1; 5; 3; 0 | — |
| SECONDARY Wound Area Reduction (mm^2) |
-388.4; -296.3; -274.7 | — |
| SECONDARY Frequency of Dressing Changes Between Visits |
1.36; 0.511; 3.56 | — |
| SECONDARY Tissue Type of Wound Bed |
2.13; 1.54; 2.5; -6.48; -2.69; -0.833 | — |
| SECONDARY Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Malodour |
3; 0; 0; 45; 8; 9 | — |
| SECONDARY Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Redness/Irritation |
8; 0; 1; 53; 13; 9 | — |
| SECONDARY Status of the Wound and Peri-wound Skin From Baseline to Last Visit: Maceration |
16; 0; 5; 39; 13; 7 | — |
| SECONDARY Handling and Technical Performance of the Dressing |
57.8; 100.0; 66.7; 56.4; 85.7; 63.6 | — |
| SECONDARY Comfort, Conformability, and Acceptability of the Dressings by Subject |
44.3; 57.1; 66.7; 41.0; 64.3; 66.7 | — |
Eligibility Criteria
Inclusion Criteria
- Signed Informed Consent Form
- Both gender ≥ 18 years old
- From Medium to High exuding wound
Exclusion Criteria
- Known allergy or hypersensitivity to any of the treatment dressings
- Pregnant or lactating females
- Subjects with a target wound that is ≤1 cm2
- Subjects with a target wound that is a full thickness burn
- Subjects with a target wound that is a full thickness pressure ulcer
- Subjects with known immunodeficiency
- Subject taking systemic antibiotics for wound infection
- Subject were the target wound is located on an infected limb interfered by minimal blood flow in the opinion of the investigator
- Subject with a target wound with unexplored enteric fistula
- Subjects who in the opinion of the investigator, will have problems following the protocol
- Subjects needing treatment with oxidizing agents such as hypochlorite solutions or hydrogen peroxide
- Previously enrolled in the present investigation
- Inclusion in other ongoing investigations at present that would preclude the subject from participating in this investigation as judged by the investigator
- Involvement in the planning and conduct of the clinical investigation
Data sourced from ClinicalTrials.gov (NCT03249909). 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.