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)

June 28, 2025 updated by: Simona Deidda, University of Cagliari

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Cagliari
      • Monserrato, Cagliari, Italy, 09042
        • Policlinico Universitario Monserrato "Duilio Casula" - AOU Cagliari

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gel containing a Propionibacterium extract
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.
Active Comparator: Hyaluronic acid and silver sulfadiazine
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of epithelialization
Time Frame: 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)
From baseline to visit 3 (40 days after the start of the treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Itching
Time Frame: From baseline to visit 3 (40 days after the start of the treatment)
Visual analogue scale (VAS) (minimum score = 0, maximum score = 10)
From baseline to visit 3 (40 days after the start of the treatment)
Burning and pain
Time Frame: From baseline to visit 3 (40 days after the start of the treatment)
Visual analogue scale (VAS) (minimum score = 0, maximum score = 10)
From baseline to visit 3 (40 days after the start of the treatment)
Bowel movements
Time Frame: At visit 3 (40 days after the start of the treatment)
Bristol Scale (minimum score =1, maximum score =7)
At visit 3 (40 days after the start of the treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cagliari

Collaborators

University Hospital of Ferrara
ASL Roma 6
Azienda Policlinico Umberto I
Hospital San Pietro Fatebenefratelli

Investigators

  • Principal Investigator: Deidda, University of Cagliari

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2025

Primary Completion (Actual)

March 4, 2025

Study Completion (Actual)

May 30, 2025

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 6, 2025

First Posted (Actual)

March 12, 2025

Study Record Updates

Last Update Posted (Actual)

July 2, 2025

Last Update Submitted That Met QC Criteria

June 28, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TheHemorrStudy_Vers_05_02_2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastrointestinal Diseases

Clinical Trials on Gel containing a Propionibacterium extract

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Turkmenistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe