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| Name | Class |
|---|---|
| Azienda Policlinico Umberto I | OTHER |
| Hospital San Pietro Fatebenefratelli | OTHER |
| University Hospital of Ferrara | OTHER |
| ASL Roma 6 |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gel containing a Propionibacterium extract | Experimental |
| |
| Hyaluronic acid and silver sulfadiazine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| From baseline to visit 3 (40 days after the start of the treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Burning and pain | Visual analogue scale (VAS) (minimum score = 0, maximum score = 10) | From baseline to visit 3 (40 days after the start of the treatment) |
| Itching | Visual analogue scale (VAS) (minimum score = 0, maximum score = 10) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deidda | University of Cagliari | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico Universitario Monserrato "Duilio Casula" - AOU Cagliari | Monserrato | Cagliari | 09042 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42334667 | Derived | Deidda S, Eberspacher C, Argiolas V, Ventrone L, Testa A, Ascanelli S, Rossin E, Lisi G, Mascagni D, Zorcolo L. Evaluation of the efficacy of a Propionibacterium extract gel in wound healing and symptom relief after open excisional hemorrhoidectomy: a randomized clinical study. Tech Coloproctol. 2026 Jun 23. doi: 10.1007/s10151-026-03381-x. Online ahead of print. |
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| OTHER |
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| 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. |
|
| From baseline to visit 3 (40 days after the start of the treatment) |
| Bowel movements | Bristol Scale (minimum score =1, maximum score =7) | At visit 3 (40 days after the start of the treatment) |
| ID | Term |
|---|---|
| D001004 | Anus Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D002921 | Cicatrix |
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| D012837 | Silver Sulfadiazine |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D013411 | Sulfadiazine |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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