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)

Phase 4

Completed

• Conditions: Anus Diseases; Gastrointestinal Diseases; Intestinal Diseases; Cicatrization; Hemorrhoids; Hemorrhoids Third Degree
• Interventions: Device: Gel containing a Propionibacterium extract; Drug: Hyaluronic acid and silver sulfadiazine

• Registration Number: NCT06872151
• Lead Sponsor: University of Cagliari

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-04
• Primary Completion: 2025-03-04
• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-06
• Study First Posted: 2025-03-12
• Study Completion: 2025-05-30
• Last Update Submitted: 2025-06-28
• Last Update Posted: 2025-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gel containing a Propionibacterium extract	Gel containing a Propionibacterium extract	-
Hyaluronic acid and silver sulfadiazine	Hyaluronic acid and silver sulfadiazine	-

Primary Outcome Measures

Name	Time	Method
Degree of epithelialization	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Policlinico Universitario Monserrato "Duilio Casula" - AOU Cagliari; 🇮🇹 Monserrato, Cagliari, Italy