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NCT Number: 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)

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.

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Key information

Conditions

Anus Diseases Cardiovascular Diseases Cicatrix Cicatrization Digestive System Diseases Fibrosis Gastrointestinal Diseases Hemorrhoids Hemorrhoids Third Degree Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Policlinico Universitario Monserrato "Duilio Casula" - AOU Cagliari

Monserrato, Cagliari, 09042, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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:

    • < 50%
    • > 50%
    • 100% (complete healing)

Secondary outcomes

  1. 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)

  2. 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)

  3. Bowel movements

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

    Bristol Scale (minimum score =1, maximum score =7)

Sponsors and collaborators

Lead sponsor

University of Cagliari

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 12, 2025
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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