Comparision of the Effectiveness of Arnebia euchroma Ointment and Phenytoin Cream 1% in Pressure Ulcer in patients with Spinal Cord Injury: A randomized clinical trial

Evaluation of the efficacy of topical Arnebia Euchroma ointment on Pressure ulcer

Two arm parallel group randomized clinical trial, Triple blinded, 80 patients

Among the referrals to Ahwaz Welfare Services Clinic, 80 patients with Pressure ulcer that have met the inclusion criteria, are chosen by a doctor. The personal and medical information questionnaire is completed for each patient and the lesions number and wound grade are determined by the researcher in each patient(Based on pressure ulcer staging protocol table NPUAP). Then patients (with grade 2 and 3 ulcer)are randomly divided into two groups, and for a period of 5 weeks, Intervention group is applied topical Arnebia Euchroma ointment and Control group is applied Phenytoin cream 1% on Pressure ulcer twice daily. Both groups receive wound care training (Washing with normal saline, change position at least every 1 hour,Learning how to help the patient move to reduce shearing forces&friction, Use wavy mattresses on the bed, Wheelchair Inflatable Mattress). Patients will be examined during this time at one week intervals and the wound healing measurement is based on the Protocol of Pressure Ulcer Scale for Healing tool(PUSH Tool).

People with spinal cord injuries with pressure ulcers; Age 15 to 75 years; Necessary Cooperation in drug use; Grade 2 and 3 Wounds; Having one or more pressure ulcer; The largest wound diameter is less than 15 cm; Written informed consent; Possible follow up

Intervention group: are applying Arnebia Euchroma ointment on ulcer twice daily for 5 weeks. Both groups receive wound care training. Control group: are applying Phenytoin cream 1% on ulcer twice daily for 5 weeks.

ulcer stage; size; exudate; Pressure ulcer scale for Healing; Time of ulcer Healing.

Stratified randomization is used. Patients are divided into two groups of grade 2 and 3 according to the degree of wound and then each category randomized with using a randomized list. The block randomization method is used to make a random list. 4 member blocks maked then they are selected using a random number table. The randomization list is compiled by a professor of statistics and the doctor will refer the selected patients to the nurse responsible for deliver the medication. This nurse is not involved in other stages of treatment, review of treatment progress, and evaluations. The drugs are delivered to both groups in the same package and color.

The participant and clinical caregiver and principal investigator,and the dressing nurse and data evaluator doctor are not aware from the type of drug used. Initially it is explained to the patients that they are randomly assigned to one of two treatment groups. The drugs of both groups are synchronized and it's delivered in similar packages.