Evaluation of the effect of alginate gel containing silver nanoparticles in the healing of skin wounds - Phase 1 and 2 clinical trial

Evaluation of the effect of alginate gel containing silver nanoparticles in the healing of skin wounds

Randomized and single-blind clinical trial in two intervention and control groups on 30 patients

30 patients with grade 2 wounds were selected from the medical centers of Kerman University of Medical Sciences, after giving oral explanations and obtaining written consent. Then the patients are divided into 2 control and intervention groups. In the intervention group, after washing the wound with normal saline, silver gel is placed on the site. The dressing is changed every 48 hours. On days 0, 3, 7, and 10, microbial culture is performed to check the reduction of infection. (Every time the dressing is changed, a photograph is taken of the wound site in order to check the healing process of the wound). Silversulfadiazine ointment is used instead of silver alginate gel in the control group, and it will be done in the same way as the intervention group.

Inclusion criteria: age between 18 and 95 years, patients confirmed to have grade 2 ulcers, without antibiotic treatment, exclusion criteria: patients who do not want to continue the clinical trial for any reason. Patients with underlying diseases such as uncontrolled diabetes, autoimmune diseases, or patients undergoing chemotherapy drugs, etc., or wounds that become infected.

Intervention group: In this group, after washing the wound with normal saline, patients put silver gel on the site and put a protective dressing on it. Control group: In this group, after washing the wound with normal saline, common wound treatment that includes silver sulfadiazine and nitrofurazone ointment is applied to the wound every other day.

Measurement of wound surface, amount of wound bacteria

Random allocation of patients to the intervention and control groups is done by the block diagnosis method and using blocks of 4, in each of the blocks 2 people are placed in the intervention group and 2 people in the control group, but they must be regularly to be placed It will be a random form that this will be done with Winpappy software

In this study, the researcher numbers the formulation of the container containing the medicinal formula so that the patient is unaware of the contents of the container.

Non-identifiable personal data of the participants, study protocol, statistical analysis map, informed consent form will be shared after the end of the study.

6 months after the results are published

All researchers working in academic and scientific institutions

The data can be analyzed and exploited within the framework of the study protocol, but the right to publish the data will be with the research team. People who wish to have access to data or documents should send their written request to the project manager's email and explain their reason for needing these data and documents and how they will use them.

Corresponding of project

The applicant must first submit a request including the requested data or document, the reason for the need for this data or document and the uses he will make of it along with a brief introduction of himself and the company or university where he works. This request will be reviewed as soon as possible, and then, taking into account the conditions of the request, if the answer is positive, the data will be provided to the applicant.