Treatment of chronic malodorous wounds using a special gel and platelet-rich plasma
Repairing Gel (Supraz) and Platelet-rich Plasma-Fibrin Glue (PRP-FG) in Eliminating Odor and Healing the Malodorous Chronic Wounds Versus Standard of Care
PHASE2; PHASE3 · Mashhad University of Medical Sciences · NCT05983302
This study is testing if a special gel combined with platelet-rich plasma can help heal stubborn, smelly wounds better than standard treatments.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Sex | All |
| Sponsor | Mashhad University of Medical Sciences (other) |
| Locations | 2 sites (Thessaloniki and 1 other locations) |
| Trial ID | NCT05983302 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a repairing gel (Supraz) combined with platelet-rich plasma-fibrin glue (PRP-FG) in treating chronic wounds that are difficult to heal and have unpleasant odors. It is a randomized controlled trial where participants will receive either the combination of Supraz and PRP-FG, Supraz alone, PRP-FG alone, or standard wound care with saline irrigation. The treatment will be administered every 48 hours for a duration of 8 weeks to assess improvements in wound healing and odor elimination.
Who should consider this trial
Good fit: Ideal candidates are individuals with a single chronic wound that has persisted for at least 3 months and has not responded to standard wound care.
Not a fit: Patients with concurrent diseases affecting wound healing or those on medications that interfere with healing may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the healing of chronic wounds and reduce associated odors, enhancing the quality of life for patients.
How similar studies have performed: Other studies have shown promising results with similar approaches using platelet-rich plasma in wound healing, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Having a single wound on the body that has been at least 3 months old and has not been repaired by wound irrigation with normal saline and changing the dressing * Having a body mass index of 18-35 * Sign the informed consent by the patient Exclusion Criteria: * Having concurrent diseases that may cause problems in wound healing, such as cancers, vasculitis, kidney and liver failure, and heart failure * Taking certain drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic agents
Where this trial is running
Thessaloniki and 1 other locations
- Medical School, Aristotle University of Thessaloniki — Thessaloniki, Greece (NOT_YET_RECRUITING)
- Mashhad University of Medical Sciences — Mashhad, Razavi Khorasan, Iran, Islamic Republic of (RECRUITING)
Study contacts
- Principal investigator: Daryoush Hamidi Alamdari, Ph.D — Surgical Oncology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
- Study coordinator: Daryoush Hamidi Alamdari, Ph.D
- Email: hamidiad@mums.ac.ir
- Phone: +98 9151017650
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Wounds and Injuries, Platelet-Rich Plasma-Fibrin Glue, Repairing Gel, Chronic Wounds, Malodorous, Recalcitrant