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)

NCT ID: NCT06872151

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-04
• Study Completion Date: 2025-05-30

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.

Conditions

Anus Diseases; Gastrointestinal Diseases; Intestinal Diseases; Cicatrization; Hemorrhoids; Hemorrhoids Third Degree

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gel containing a Propionibacterium extract

Group Type: EXPERIMENTAL

Gel containing a Propionibacterium extract

Intervention Type: DEVICE

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.

Hyaluronic acid and silver sulfadiazine

Group Type: ACTIVE_COMPARATOR

Hyaluronic acid and silver sulfadiazine

Intervention Type: DRUG

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.

Interventions

Gel 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.

Intervention Type: DEVICE

Hyaluronic 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Policlinico Umberto I

OTHER

Sponsor Role: collaborator

Hospital San Pietro Fatebenefratelli

OTHER

Sponsor Role: collaborator

University Hospital of Ferrara

OTHER

Sponsor Role: collaborator

ASL Roma 6

OTHER

Sponsor Role: collaborator

University of Cagliari

OTHER

Sponsor Role: lead

Responsible Party

Simona Deidda

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deidda

Role: PRINCIPAL_INVESTIGATOR

University of Cagliari

Locations

Policlinico Universitario Monserrato "Duilio Casula" - AOU Cagliari

Monserrato, Cagliari, Italy

Countries

Italy

Other Identifiers

TheHemorrStudy_Vers_05_02_2024

Identifier Type: -

Identifier Source: org_study_id