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)

University of Cagliari

Status and phase: Completed; Phase 4

Conditions: Gastrointestinal Diseases; Hemorrhoids Third Degree; Intestinal Diseases; Anus Diseases; Cicatrization; Hemorrhoids

Treatments: Device: Gel containing a Propionibacterium extract; Drug: Hyaluronic acid and silver sulfadiazine

Study type: Interventional

Funder types: Other

Identifiers

NCT06872151

TheHemorrStudy_Vers_05_02_2024

Details and patient eligibility

About

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.

Enrollment: 114 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups

Gel containing a Propionibacterium extract

Experimental group

Treatment:

Device: Gel containing a Propionibacterium extract

Hyaluronic acid and silver sulfadiazine

Active Comparator group

Treatment:

Drug: Hyaluronic acid and silver sulfadiazine