Case Study
Clinical Investigation Plan for Wound Dressing (RCT – 20 Weeks)
A randomized controlled clinical investigation designed to assess safety, efficacy, and wound healing outcomes for a chronic venous leg ulcer population over 20 weeks.
The Client Challenge
- ✔ Required CER for EU-MDR compliance.
- ✔ Needed updated alignment with SHI reimbursement standards.
- ✔ Evaluate wound dressing effectiveness vs. SoC.
Objectives
- ✔ Measure % change in wound area & depth.
- ✔ Evaluate healing time & dressing duration.
- ✔ Track dressing change frequency & closure rate.
Our Approach
- ✔ RCT comparing wound dressing vs SoC.
- ✔ Baseline → repeated timepoint evaluations.
- ✔ Focus on clinically meaningful outcomes.
- ✔ Patient-centric reporting included.
The Scope
- ✔ 20-week RCT study duration.
- ✔ Focused on chronic venous leg ulcers.
- ✔ Measurement of both safety and efficacy.
Outcome
1. Clear Objectives:
- Clearly outlined primary and secondary objectives to guide the study’s direction in CIP.
- Ensured objectives are specific, measurable, achievable, relevant, and time-bound (SMART).
2. Comparative Analysis:
- Designed a randomized controlled trial (RCT) to compare the effectiveness of the dressing agent with the standard of care (SoC).
- Utilized appropriate statistical methods to analyze outcomes between treatment groups.
- Blinded and randomized approach was used to minimize bias and enhance the validity of the comparative analysis.
3. Longitudinal Assessment:
- Implemented a prospective design to track wound healing parameters over time.
- Collected data at multiple time points to evaluate healing progression and durability of treatment effects.
4. Baseline Evaluation:
- Conducted baseline assessments of wound characteristics and patient demographics.
- Established a starting point for measuring wound area, depth, and outcome improvements.
5. Comprehensive Secondary Objectives:
- Included secondary objectives for a holistic evaluation of wound management outcomes.
- Assessed healing time, dressing wear duration, frequency of dressing changes, and patient-reported outcomes.
6. Clinical Relevance:
- Prioritized outcomes that are meaningful for both patients and healthcare professionals.
- Focused on clinically relevant endpoints such as wound closure, pain relief, and quality of life.
7. Patient-Centric Approach:
- Designed the study with a strong focus on patient needs, preferences, and treatment goals.
- Included patient-reported outcomes (PROs) to understand patient satisfaction and real-world experience.
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Cetas Healthcare is a global leader in conducting ISO 14155-compliant Post-Market Clinical Follow-up (PMCF) surveys for MedTech devices. We specialize in designing and managing robust PMCF studies that capture real-world clinical evidence for Class II and III devices. To date, we’ve handled 25,000+ patient case forms, enabling clients to strengthen CE certification submissions and maintain full compliance with EU MDR requirements. By combining rigorous clinical research with actionable insights, we help MedTech companies continuously monitor device performance and enhance patient safety.
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