Study of the effect of chitosan wound dressing containing antibiotics on recovering process of the infected wounds

Investigating the effectiveness of chitosan wound dressings containing antibiotics on surgical wounds, bedsores, transplant wounds, burn wounds, diabetic foot wounds, infectious wounds, and wounds prone to infection.

A controlled, single-blind, randomized, phase 3 clinical trial on 20 patients.

The wound dressing will be prepared at Medical Biomaterials Research Center Tehran University of Medical Sciences. Patients referred to Farmaniyeh Hospital are selected by a specialist doctor. The dressing will be placed on the damaged wound and its healing process will be monitored by the attending physician for a week and every day after dressing.

Patients with surgical wounds, bedsores, transplant site wounds, diabetic foot and infected wounds and wounds prone to infection will be included in the study. Patients with deep wounds with abscess, osteomyelitis, presence of local or extensive non-debriding gangrene, venous ulcers, malignancy in the wound area, and pregnant women will be excluded from the study.

The intervention group is the group that will receive the chitosan wound dressing containing antibiotics, and the control group is the group that will receive the usual dressing as a wound dressing.

Wound quality and healing of infection

Randomization is done in a simple way and the table of random numbers will be used as a tool. Even numbers are for the intervention group and odd numbers are for the control group. Then, according to the number of the studied sample, the corresponding numbers are extracted from the table of random numbers or using a computer, and each number is written on a card and placed in an envelope, and the envelopes are sealed, and on each envelope the number The patient is written. The first patient who is enrolled in the study and enters the study will be given the envelope related to patient number 1, patient number 2 will be given envelope number 2 and so on, and this will continue until the end of the study sample. In order to maintain randomization, the person who prepares the envelopes will be different from the person who registers the patients and provides the envelopes to the patients.

Only study participants are blinded. This means that only the participants do not know which group they have been placed in and whether they have been prescribed a drug or a placebo. It is tried that the patients do not meet each other during their visits, and their appointments are made separately at different times. During wound dressing, all patients will be told that the same dressings will be used for them.

The data from this study will be published as an article or a report.

The access period starts 6 months after the results are published

The resulting data will be available for researchers working in academic and scientific and clinical institutions

There are no special conditions.

To receive the data, applicants can refer to Tehran University of Medical Sciences, located on 16 Azar St.

Researchers can access the data by searching the Internet.