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)

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

Interventions

DEVICE

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.

DRUG

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.

Sponsors & Collaborators

• Azienda Policlinico Umberto I

  collaborator OTHER

• Hospital San Pietro Fatebenefratelli

  collaborator OTHER

• University Hospital of Ferrara

  collaborator OTHER

• ASL Roma 6

  collaborator OTHER

• University of Cagliari

  lead OTHER

Principal Investigators

• Deidda · University of Cagliari

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-04

Primary Completion

2025-03-04

Completion

2025-05-30

Countries

• Italy

Study Locations