Managing the problem of excess exudate.
Zena Moore, Helen Strapp
https://pubmed.ncbi.nlm.nih.gov/26266558/Actively Recruiting
Led by Molnlycke Health Care AB · Updated on 2023-04-20
68
Participants Needed
4
Research Sites
N/A
Total Duration
Researchers are evaluating the progress of chronic wounds, specifically venous leg ulcers VLU and diabetic foot ulcers DFU, using an absorbent dressing called Mepilex Up. This study is a prospective, open, multi-center, interventional trial designed to observe wound healing over a period of up to six weeks. The goal is to track changes in wound area and condition while participants receive treatment according to local standards of care. Participants will use the Mepilex Up dressing, which is a soft, silicone-based absorbent foam dressing designed to manage wound exudate and protect the skin. The dressing will be applied as the primary dressing and changed weekly for up to six weeks or until the wound heals. The study includes seven visits a baseline visit followed by weekly visits to monitor wound healing and dressing performance. During each visit, researchers will assess wound progress through measurements and evaluations of wound area, volume, tissue quality, exudate, and skin condition. Participants will report on pain, comfort, and quality of life related to wound care. Safety will be monitored at all visits. The total treatment period is a maximum of 44 days or until healing occurs, with detailed tracking of dressing wear time, wound changes, and any adverse events.
CONDITIONS
A Clinical Investigation to Follow the Progress of Exuding Chronic Wounds Using Mepilex® Up as the Primary Dressing.
J
Janet Kandrevas, MD, MS
A
Andrea Picchietti, MS, CCRA
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Molnlycke Health Care AB
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Mepilex Up dressing (with supportive care) | Standard absorbent foam dressing (with supportive care) |
|---|---|---|
| What it is | A highly conformable silicone foam dressing (Mepilex Up) used as the primary wound covering for chronic, exuding venous leg ulcers or diabetic foot ulcers. Designed to manage moderate to large exudate, maintain moisture, and reduce trauma at dressing changes. | Absorbent silicone foam dressing (other than Mepilex Up), widely used as standard care for chronic exuding wounds. Intended for exudate absorption, wound protection, and moist healing environment. |
| Role in trial | The sole investigational intervention, applied as the primary dressing to all eligible study wounds. Used continuously over the study period to assess wound progress and treatment endpoint. | Not evaluated in this trial, but represents the foam dressings commonly used outside of research settings for similar wounds. |
| Primary use | Absorbing exudate, protecting wound and peri-wound skin, maintaining moisture, and minimizing pain and trauma at dressing changes. | Absorbing high levels of exudate and protecting wound and surrounding tissue to support healing in chronic wounds. |
| How it is given or performed | Dressing is applied directly to the wound bed, secured as primary dressing. Changed according to wound condition and exudate level, per clinical assessment, for up to 44 days or until healing. | Standard absorbent foam dressings are typically applied as the primary covering, with frequency of change according to exudate and clinical assessment, in line with current practice guidelines. |
| Evidence status | Currently under prospective clinical evaluation in a single-arm study; no comparative trial result posted. Published studies provide rationale for managing exudate and protecting skin with such dressings, but direct published outcome data for Mepilex Up in this population are not yet established. | Current evidence, including systematic reviews, supports use of absorbent foam dressings to manage exudate and promote healing in chronic venous and diabetic foot ulcers, though variations exist in performance and patient comfort across brands. |
| Important limitations | Single-arm study design without a control group within the same protocol. Effectiveness and relative benefit compared to other dressings can only be inferred indirectly until head-to-head data are available. Some patient populations (e.g. infected, circumferential wounds) are excluded. | Performance varies by dressing brand and wound characteristics. Not all commercially available foams minimize pain or trauma at dressing removal. Comparative pain and healing data are limited, and matching dressing choice to specific wound needs may affect outcomes. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks or until healed
Participants use Mepilex Up as the primary dressing for their chronic exuding wounds and attend weekly visits to assess wound progression, dressing properties, pain, comfort, quality of life, and safety.
7 visits (1 baseline and 6 weekly follow-up visits, in-person)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/25486905/Molnlycke Health Care AB
Lead Sponsor