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)

NCT06872151 | Completed Phase 4

• 1 other identifier: TheHemorrStudy_Vers_05_02_2024
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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

Keywords

hemorrhoids; epithelialization; Anal diseases; hemorrhoidectomy

Outcome Measures

Primary Outcomes (1)

• Degree of epithelialization

  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 Outcomes (3)

• Burning and pain

  From baseline to visit 3 (40 days after the start of the treatment)

• Itching

  From baseline to visit 3 (40 days after the start of the treatment)

• Bowel movements

  At visit 3 (40 days after the start of the treatment)

Study Arms (2)

Gel containing a Propionibacterium extract

EXPERIMENTAL

Device: Gel containing a Propionibacterium extract

Hyaluronic acid and silver sulfadiazine

ACTIVE COMPARATOR

Drug: Hyaluronic acid and silver sulfadiazine

Interventions

Gel containing a Propionibacterium extract 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.

Gel containing a Propionibacterium extract

Hyaluronic acid and silver sulfadiazine 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.

Hyaluronic acid and silver sulfadiazine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Open excisional hemorrhoidectomy, with removal of at least 3 groups
• Age between 18 and 75 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cagliari: lead
• Azienda Policlinico Umberto I: collaborator
• Hospital San Pietro Fatebenefratelli: collaborator
• University Hospital of Ferrara: collaborator
• ASL Roma 6: collaborator

Study Sites (1)

Policlinico Universitario Monserrato "Duilio Casula" - AOU Cagliari

Monserrato, Cagliari, 09042, Italy

Location

MeSH Terms

Conditions

Anus Diseases; Gastrointestinal Diseases; Intestinal Diseases; Cicatrix; Hemorrhoids

Interventions

Hyaluronic Acid; Silver Sulfadiazine

Condition Hierarchy (Ancestors)

Rectal Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Sulfadiazine; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Officials

• Deidda

  University of Cagliari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 12, 2025
• Study Start: March 4, 2025
• Primary Completion: March 4, 2025
• Study Completion: May 30, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)