Health Condition 1: null- Pressure Ulcers
Conditions
Interventions
Intervention1: This is a single-arm, open-label, multi-center clinical study to be conducted with approximately 30 subjects who are diagnosed with Stage II, III or IV pressure ulcers (according to NPU
Sponsors
CONVATECH
Clinkom Research pvt ltd
Eligibility
Inclusion criteria
Inclusion criteria: • Subjects >=18 and • Subjects with Stage II, III or IV pressure ulcers (according to NPUAP staging definitions) that are moderately to heavily exudating. • Subjects who have an ulcer that meets at least 2 of the 4 following clinical signs: pain between 2 dressing changes, perilesional skin erythema, foul odor and heavy exudation. o Note: If more than one ulcer is present, the largest ulcer that can be covered by the foam dressing will be chosen as the target ulcer. However, the ulcer size should be able to be covered by a 15cm x 15cm window with a 1cm clearance.
Exclusion criteria
Exclusion criteria: • Subjects with a history of skin sensitivity to any of the components of the study product. • Subjects who have ulcers that have erysipelas/are malignant. • Subjects who have progressive neoplastic lesion treated by radiotherapy or chemotherapy, or on-going treatment with immunosuppressive agents or high dose corticosteroids. • Subjects who have participated in a clinical study within the past 3 months. • Subjects who are pregnant or breastfeeding. • Subjects with pressure ulcers that cannot be covered by a 15cm x 15cm window with a 1cm clearance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is performance evaluation of exudate management and adhesion of AQUACEL® foam adhesive dressing in the management of pressure ulcers. Timepoint: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are evaluation of mean wear time, evidence of clinical improvement, clinician feedback on ease of use and subject feedback on pain during dressing change along with safety evaluation of the device.Timepoint: 28 days | — |
Countries
India
Contacts
Public ContactDrKishore Babu
Mahima Diabetic Centre
Outcome results
None listed