Evaluation of the Effectiveness of a Topical Medical Device in Wound Healing and Symptom Relief in the Postoperative Period of Open Excisional Hemorrhoidectomy (The Emor Study)

Evaluation of the Effectiveness of a Gel Containing a Propionibacterium Extract in Wound Healing and Symptom Relief, Such as Pain, Itching, and Burning, in the Postoperative Period of Open Excisional Hemorrhoidectomy

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.

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