Clinical Studies with Chitosan
Chitosan is not only used for feverish laboratory-scale research, but also for specific application in chitosan-based products for a wide variety of indications, which are being tested in clinical studies. In this article we provide an insight into current clinical studies on chitosan and present the results of two studies on chronic wound healing and improved hemostasis after puncture of the radial artery.
Currently, the website clinicaltrial.gov lists 10 clinical studies (search term chitosan) with the status “recruiting” (see table below).
Table 1: List of clinical studies containing the search term chitosan according to clinicaltrial.gov (accessed 05.03.2018).
|Chitosan Nerv Tube for Primary Repair of Traumatic Sensory Nerve Lesions of the Hand||Traumatic Lesion of Sensory Nerves of the Hand||
Device: Chitosan nerve tube in addition to gold standard therapy
Procedure: Gold standard Primary
|Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan (Mediclore®)||Gynecologic Disease||
|Comparison of Oral Morphine Versus Nasal Ketamine Spray With Chitosan in Cancer Pain Outpatients||Cancer: Breakthrough Pain Cancer: Extreme Pain on Movement||Drug: Morphine
|Hemostasis Pad Using Chitosan After Invasive Percutaneous Procedures||Coronary Artery Disease Puncture||Device: ezClot (hemostasis pad)
Device: BloodSTOP ix pad
Device: Rotary compression device
|To Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®)||Gynecologic Disease||Device: Mediclore® (adhesion barrier)||Korea|
|Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®) After Axillary Dissection for Breast Cancer||Breastcancer||
Surgery: Axillary Dissection
Device: adhesive barrier
|Functional Chewing Gum in Reduction of Gingival Inflammation||Gingivitis||Device: Functional Chitosan Chewing GumDevice: Control Chewing Gum
Behavioral: Oral hygiene measures
|Dental Extractions in Patients Under Dual Antiplatelet Therapy||
Blood Coagulation Disorders
Device: HemCon Dental Dressing
Device: Oxidized Cellulose Gauze
|Nonneoplastic Epithelial Disorders of Vulva and High Intensity Focused Ultrasound||Vulva Intraepithelial Nonneoplastic||
Device: the high intensity focused ultrasound (Mianyang Sonic electronic LLC)
Drug: Fu Tiankang disposable vaginal filling suppository, Albothyl (Policresulen Solution) , and the gynecologic medical antimicrobial dressing gel (chitosan gel)
|Performance Study of an Artificial Nerve Guide (Reaxon® Nerve Guide) to Treat Digital Nerve Lesions||Peripheral Nerve Injuries||Device: Implantation||Germany|
Below we present the results of two completed chitosan-related studies.
Chitosan has promising properties in treatment of chronic wounds. These kinds of wounds are highly problematic for patients and very expensive for the health care system. Pressure ulcers are a common kind of chronic wound, with mainly bedridden people being affected. A large number of studies already reported that chitosan is excellent for wound treatment. The following clinical study deals with the treatment of such chronic wounds using chitosan.
Chitosan Gel to Treat Pressure Ulcers: A Clinical Pilot Study
Campani V., Pagnozzi E., Mataro I., Mayol L., Perna A., D´Urso F., Carillo A., Cammarota M., Maiuri M.C., De Rosa G. Pharmaceutics.10 (1). pii: E15. doi: 10.3390/pharmaceutics10010015. January 2018
They reported a clinical study on 20 patients with pressure ulcers and treated with Chitosan (viscosity >400 mPas) gel prepared in the hospital. In the study, the efficacy and the tolerability of the treatment were evaluated.
For the study, a number of patients between 40-80 years were enrolled in the study over 30 days. Lesions were cleaned with povidone iodine solution and physiological solution. The whole area of the decubitus ulcer was coated with Chitosan gel and covered with a secondary dressing. The dressing was renewed two times a week in an outpatient clinic. Each time the area of the skin lesion was measured and the patients assessed their satisfaction level on a visual analogue scale (VAS) ranging from not satisfied (0) to fully satisfied (100). Reduction of the wound area by at least 20% after four weeks of treatment was chosen as endpoint. Additionally the tolerability of the Chitosan gel was investigated.
Results after 4 week treatment with Chitosan gels:
- Significant reduction (>20%) of wound area for most patients (90%)
- For 20% of patients the lesion was completely healed
- For 50% of cases a reduction of 50% was reached
Conclusion: The study showed the efficacy of Chitosan gel in improving wound healing. For the majority of patients enrolled in the study, lesion area was significantly reduced. As the next step, the effect of the Chitosan gel needs to be demonstrated with a larger number of study participants to confirm results of the presented study. On-site preparation of the chitosan gel makes the device cost-efficiently and a promising approach for the treatment of pressure ulcers.
We continue with the following exciting study:
Hemostasis pad combined with compression device after transradial coronary procedures: A randomized controlled trial.
Kang S.H., Han D., Kim S., Yonn C.H., Park J.J., Suh J.W., Cho Y.S., Youn T.J., Chae I.H. PLoS One. 2017 Jul 24, 12(7):e0181099. Doi: 10.1371/journal.pone.0181099. eCollection 2017.
Coronary angiography is used for diagnosis of coronary arteries. This procedure is performed by getting access to the arterial system from femoral artery or radial artery in the wrist. The radial access has many advantages, but complications such as severe bleeding at the injection site or vascular occlusion are still possible. In order to reduce these, effective and successful hemostasis is particularly important. To stop the bleeding, compression devices or hemostasis pads are often used. The clinical study investigated whether the combinded use of chitosan-based pads and a compression device improved the efficacy of hemostasis after transradial coronary angiography compared to the sole use of the compression device.
The non-blinded study was performed at a single study center. The patients who underwent coronary angiography with transradial approach were randomly assigned to a study group (compression device with or without chitosan-based wound dressing). A 4 month study with 95 participants, thereof 59 in treatment group (rotatory compression device plus hemostasis pad) and 36 in control group (rotatory compression device alone) was performed. The primary endpoint of the study was hemostasis (Categories: ≤5, 6-10, 11-20, and >20 minutes).
- Significant reduced hemostasis time in treatment group compared to control group
- Occurrence of vascular complications was low for both groups
Limitations of the study are the small number of patients and the lack of long-term assessment of the vascular access site, e.g. with ultrasound.
Conclusion: Study results indicate that the additional application of chitosan based pads with a compression device is a promising approach for treatment of puncture site after radial artery access.