This multicenter randomized controlled phase IV trial aims to compare the clinical efficacy of a gel containing a Propionibacterium extract and a gel with hyaluronic acid and silver sulfadiazine in the degree of epithelialization of post-operative wounds of open excisional hemorrhoidectomy. The main questions it aims to answer are: * To compare the efficacy of the two medical devices in the degree of epithelialization in the postoperative period of open excisional hemorrhoidectomy, at 0, 10, 20 and 40 days from the beginning of treatment. * To evaluate the effectiveness of these devices in alleviating: pain, itching, burning, and the type of bowel habit Participants will be randomized, at the beginning of the study, to one of the two treatments, and the efficacy of the two medical devices will be evaluated at 0, 10, 20 and 40 days from the start of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
114
Patients will apply 1 ml of gel (equal to one phalanx) twice a day for 20 days, manually at the anal level and in the perianal area. In the morning, after defecation and in the evening before going to bed.
Patients will apply 1ml of gel (equal to a phalanx) twice a day for 20 days, manually at the anal level and in the perianal area. In the morning, after defecation and in the evening before going to bed.
Policlinico Universitario Monserrato "Duilio Casula" - AOU Cagliari
Monserrato, Cagliari, Italy
Degree of epithelialization
The degree of epithelialization of the fissure was determined at each visit and stratified using 3 levels (1 to 3) corresponding to: 1. \< 50% 2. \> 50% 3. 100% (complete healing)
Time frame: From baseline to visit 3 (40 days after the start of the treatment)
Burning and pain
Visual analogue scale (VAS) (minimum score = 0, maximum score = 10)
Time frame: From baseline to visit 3 (40 days after the start of the treatment)
Itching
Visual analogue scale (VAS) (minimum score = 0, maximum score = 10)
Time frame: From baseline to visit 3 (40 days after the start of the treatment)
Bowel movements
Bristol Scale (minimum score =1, maximum score =7)
Time frame: At visit 3 (40 days after the start of the treatment)
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