(168 days)
For Over - the - Counter use, Aquacel Hydrofiber Wound Dressing may be used for: abrasions, lacerations, minor cuts, and minor scalds and burns. Under the supervision of a health care professional, Aquacel may be used for the management of: leg ulcers, pressure ulcers (Stage II-IV) and diabetic ulcers, surgical wounds (post-operative, donor sites, dermatological), second degree burns. Aquacel may also be used for: management of surgical or traumatic wounds that have been left to heal by secondary intention, local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided, donor sites, and traumatic wounds, the management of painful wounds.
AQUACEL® dressing is a soft, sterile, non-woven pad or ribbon dressing composed of hydrocolloid fibers (sodium carboxymethylcellulose).
Here's an analysis of the acceptance criteria and study information for the AQUACEL® Hydrofiber® Wound Dressing, based on the provided text:
Acceptance Criteria and Device Performance for AQUACEL® Hydrofiber® Wound Dressing
Unfortunately, the provided text does not explicitly state quantitative acceptance criteria for pain reduction. The studies described are comparative, aiming to show that AQUACEL® performs equally well or better than other dressings in terms of pain management. Therefore, the "acceptance criteria" are implied to be demonstrating comparable or superior performance to existing wound dressings.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance (AQUACEL®) |
|---|---|
| Pain on Dressing Change: | |
| - Comparable/Superior to Kaltostat® for leg ulcers | Leg Ulcers (Study 1): 76% no pain, 20% mild pain, 3% moderate pain on dressing change (Kaltostat®: 83% no pain, 13% mild pain, 4% moderate pain) - Comparable |
| - Comparable/Superior to Alginate for leg ulcers | Leg Ulcers (Study 2): 65% no pain, 16% mild pain, 3.4% moderate pain on dressing removal (Alginate: 62% no pain, 14% mild pain, 4% moderate pain) - Comparable |
| - Superior to Saline Gauze for pressure ulcers | Pressure Ulcers (Study 3): 82% rated dressing removal as excellent or good (54% excellent, 28% good) (Gauze: 24% excellent or good (7% excellent, 17% good)) - Superior |
| - Comparable/Superior to Alginate for acute surgical wounds | Acute Surgical Wounds (Foster, et al.): 92% no or mild pain at first dressing change; 84% pain-free on post-operative day 7 (Alginate: 80% no or mild pain at first dressing change; 58% pain-free on post-operative day 7) - Superior |
| - Superior to Paraffin Gauze for split-thickness donor sites | Split-Thickness Donor Sites (Barnea, et al.): Significantly lower pain scores at all evaluation points (p-values 0.0001 (day 1) to 0.03 (day 15)) - Superior |
| - Superior to Silver Sulphadiazine for partial-thickness burns | Partial-Thickness Burns (Kogan, et al.): At 30-min assessment: pain reduced to 6.1 (AQUACEL®) vs 6.9 (Silver Sulphadiazine) on day 1-2; pain reduced to 5.2 (AQUACEL®) vs 5.6 (Silver Sulphadiazine) on day 5. Authors concluded superior pain relief. |
| Pain while Dressing in situ: | Explicit quantitative data for "pain while dressing in situ" is not extracted as readily as "pain on dressing change." The studies generally support the claim that the gelling action "reduce wound pain while the dressing is in situ." The superior pain relief during dressing changes implies better patient comfort overall. |
| Non-traumatic Removal: | Implied by "ease of removal" and "without damaging newly formed tissue" due to gel formation. The pain reduction during removal directly supports this. |
| Moist Wound Environment: | Implied by Hydrofiber® technology forming a "clear, cool gel on contact with wound exudate." |
| Patient Comfort: | Generally supported by reductions in pain during wear and removal. |
2. Sample Sizes Used for the Test Set and Data Provenance:
| Study/Report | Sample Size (Test Set) | Data Provenance | Test Set Description (if applicable) |
|---|---|---|---|
| ConvaTec Studies: | |||
| 1. Leg Ulcers (moderately/heavily exudating) | 44 patients | Prospective, controlled, randomized; ConvaTec study (manufacturer-sponsored). Location not specified, but ConvaTec is a US company. | 21 managed with AQUACEL®, 23 with Kaltostat®. Mean age 68.1 years, 82% venous etiology, 89% shallow ulcer depth, median duration 10 months. |
| 2. Leg Ulcers (multicenter) | 40 patients | Prospective, controlled, randomized; ConvaTec study (manufacturer-sponsored). Location not specified. | 20 managed with AQUACEL® (269 dressing changes), 20 with alginate (227 dressing changes). Majority male (80%), average age 63 years. |
| 3. Pressure Ulcers (Stage III/IV) | 85 patients | Prospective, controlled, randomized; ConvaTec study (manufacturer-sponsored). Location not specified. | 43 with AQUACEL® (536 dressing changes), 42 with moist saline dressing/gauze (500 dressing changes). Moderately or heavily exudating. |
| Published Reports: | |||
| 1. Acute Surgical Wounds (Foster, et al.) | 100 patients | Prospective, randomized, controlled; published in peer review journal. Location not specified. | Randomized to receive either AQUACEL® or alginate dressing. |
| 2. Split-Thickness Donor Sites (Barnea, et al.) | 23 adult patients | Prospective, comparative; published in peer review journal. Location not specified. | Each patient used both AQUACEL® and paraffin gauze, with half the donor site covered by each. |
| 3. Partial-Thickness Burns (Kogan, et al.) | 22 patients | Prospective; published in peer review journal. Location not specified. | 11 patients treated with AQUACEL®, 11 with silver sulphadiazine. Patients aged 1.5 to 41 years. |
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The ground truth for pain assessment in these studies is primarily patient-reported pain scores (e.g., "no pain, mild pain, moderate pain," "analogue scale," "visual analogue scales") and, in one instance, observation of behavior for non-verbal children.
The text does not specify a number of "experts" used to establish ground truth in the traditional sense (e.g., radiologists interpreting images). Instead, the patients themselves provided the primary data for pain perception. Clinicians involved in the studies would have been healthcare professionals managing wounds, but their role was in administering the treatments and collecting patient data, not acting as independent adjudicators of the "truth" of pain.
4. Adjudication Method for the Test Set:
There is no explicit mention of an adjudication method (like 2+1 or 3+1 consensus) for the "test set" in the context of pain assessment. As noted above, the "ground truth" for pain is directly reported by the patient. For observational assessments (e.g., for non-verbal children), the text doesn't specify if multiple observers were used or if a consensus method was employed. The studies are described as "controlled" and "randomized," indicating rigorous design for comparing treatments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Based on the provided text, there is no MRMC comparative effectiveness study described for human readers improving with AI vs. without AI assistance. The device is a wound dressing, and the studies focus on its clinical performance in pain management, not on AI-assisted diagnostic or interpretative tasks.
6. Standalone (Algorithm Only) Performance:
This question is not applicable as AQUACEL® is a physical wound dressing and not an algorithm or AI-powered device.
7. Type of Ground Truth Used:
The primary type of ground truth used is patient-reported outcomes, specifically:
- Subjective pain assessment: Rated by patients as "no pain, mild pain, moderate pain," or using "analogue scales" and "visual analogue scales."
- Behavioral observation: For non-verbal children, pain was assessed by observation of behavior.
8. Sample Size for the Training Set:
The provided text does not describe a "training set" in the context of machine learning or AI. The studies are clinical trials comparing the dressing's performance against other dressings or standard care. Therefore, there's no distinction between a "training set" and "test set" in the AI sense for this product. The sample sizes mentioned above (e.g., 44, 40, 85 patients in ConvaTec studies, 100, 23, 22 in published reports) represent the total patient cohorts for these clinical performance studies.
9. How Ground Truth for the Training Set Was Established:
As there is no "training set" in the AI sense, this question is not applicable. The ground truth for pain assessment in the clinical studies was established directly from patient reporting or observation, as described in point 7.
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