Anus Diseases, Cicatrization, Gastrointestinal Diseases, Hemorrhoids, Hemorrhoids Third Degree, Intestinal Diseases
Conditions
Keywords
hemorrhoids, epithelialization, Anal diseases, hemorrhoidectomy
Brief summary
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.
Interventions
DEVICEGel containing a Propionibacterium extract
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.
DRUGHyaluronic acid and silver sulfadiazine
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.
Sponsors
Azienda Policlinico Umberto I
Hospital San Pietro Fatebenefratelli
University Hospital of Ferrara
ASL Roma 6
University of Cagliari
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Open excisional hemorrhoidectomy, with removal of at least 3 groups * Age between 18 and 75 years
Exclusion criteria
* Patients who do not consent to the study * Opioid-dependent patients, chronic use of analgesics * Fecal incontinence * Anorectal neoplasms * Immunosuppressive treatments (e.g., chemotherapy, radiotherapy, etc.) * Chronic inflammatory bowel diseases * Pregnancy * Patients with major psychiatric disorders * Known allergy to the components of the treatments under study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Degree of epithelialization | From baseline to visit 3 (40 days after the start of the treatment) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Burning and pain | From baseline to visit 3 (40 days after the start of the treatment) | Visual analogue scale (VAS) (minimum score = 0, maximum score = 10) |
| Itching | From baseline to visit 3 (40 days after the start of the treatment) | Visual analogue scale (VAS) (minimum score = 0, maximum score = 10) |
| Bowel movements | At visit 3 (40 days after the start of the treatment) | Bristol Scale (minimum score =1, maximum score =7) |
Countries
Italy
Outcome results
None listed