Clinical trial NCT06872151: 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)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Anus Diseases
Gastrointestinal Diseases
Intestinal Diseases
Cicatrization
Hemorrhoids
Hemorrhoids Third Degree
Keywords: hemorrhoids
epithelialization
Anal diseases
hemorrhoidectomy
Lead sponsor: University of Cagliari
Sponsor class: OTHER
Collaborators: name: Azienda Policlinico Umberto I
name: Hospital San Pietro Fatebenefratelli
name: University Hospital of Ferrara
name: ASL Roma 6
First posted: 2025-03-12
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Degree of epithelialization
timeFrame: From baseline to visit 3 (40 days after the start of the treatment)
Secondary outcomes:
measure: Burning and pain
timeFrame: From baseline to visit 3 (40 days after the start of the treatment)
measure: Itching
timeFrame: From baseline to visit 3 (40 days after the start of the treatment)
measure: Bowel movements
timeFrame: At visit 3 (40 days after the start of the treatment)
Other outcomes:
Locations:
city: Monserrato
country: Italy
facility: Policlinico Universitario Monserrato "Duilio Casula" - AOU Cagliari
state: Cagliari
Study officials:
affiliation: University of Cagliari
name: Deidda
role: PRINCIPAL_INVESTIGATOR
References: