Anus DiseasesPhase 4NCT06872151
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)
A Phase 4 study testing Gel containing a Propionibacterium extract and Hyaluronic acid and silver sulfadiazine in people with Anus Diseases and Gastrointestinal Diseases, run by University of Cagliari at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anus Diseases, Gastrointestinal Diseases, Intestinal Diseases
- What is being tested?
- Gel containing a Propionibacterium extract and Hyaluronic acid and silver sulfadiazine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteItaly
- Study dates
- 4 Mar 2025to 30 May 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Open excisional hemorrhoidectomy, with removal of at least 3 groups
- Age between 18 and 75 years
Who cannot join
- 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
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- Pregnancy
- Patients with major psychiatric disorders
- Known allergy to the components of the treatments under study
Trial locations and contacts
1 site in 1 country.
Italy1 site
Policlinico Universitario Monserrato "Duilio Casula" - AOU Cagliari
Monserrato, Cagliari, 09042
About this study
Official 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
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
- Being tested
- Gel containing a Propionibacterium extract, Hyaluronic acid and silver sulfadiazine
- Keywords
- hemorrhoids, epithelialization, Anal diseases, hemorrhoidectomy
- Medical subject headings
- Anus Diseases, Gastrointestinal Diseases, Intestinal Diseases, Cicatrix, Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gel containing a Propionibacterium extractDevice
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 sulfadiazineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Gel containing a Propionibacterium extract | Experimental | Not described Receives: Device: Gel containing a Propionibacterium extract |
| Hyaluronic acid and silver sulfadiazine | Active comparator | Not described Receives: Drug: Hyaluronic acid and silver sulfadiazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- < 50%
- > 50%
- 100% (complete healing)
Measured: From baseline to visit 3 (40 days after the start of the treatment)
Secondary outcomes (3)
Burning and pain
Visual analogue scale (VAS) (minimum score = 0, maximum score = 10)
Measured: From baseline to visit 3 (40 days after the start of the treatment)
Itching
Visual analogue scale (VAS) (minimum score = 0, maximum score = 10)
Measured: From baseline to visit 3 (40 days after the start of the treatment)
Bowel movements
Bristol Scale (minimum score =1, maximum score =7)
Measured: At visit 3 (40 days after the start of the treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start4 Mar 2025
- Primary completion4 Mar 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anus DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Policlinico Umberto I, Hospital San Pietro Fatebenefratelli, University Hospital of Ferrara, ASL Roma 6
- Responsible party
- Principal investigator, Simona Deidda, University of Cagliari
- Investigators
- Deidda, Principal investigator, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872151
- Sponsor's protocol ID
- TheHemorrStudy_Vers_05_02_2024
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42334667
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06872151
- Acronym / sponsor ID
- TheHemorrStudy_Vers_05_02_2024
- Conditions
- Anus Diseases, Gastrointestinal Diseases, Intestinal Diseases, Cicatrization, Hemorrhoids, Hemorrhoids Third Degree
- Keywords
- hemorrhoids, epithelialization, Anal diseases, hemorrhoidectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Collaborators
- Azienda Policlinico Umberto I, Hospital San Pietro Fatebenefratelli, University Hospital of Ferrara, ASL Roma 6
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 4 Mar 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Open excisional hemorrhoidectomy, with removal of at least 3 groups
- Age between 18 and 75 years
Key exclusion criteria (9 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gel containing a Propionibacterium extractPatients 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. | Device | Gel containing a Propionibacterium extract |
| Hyaluronic acid and silver sulfadiazinePatients 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. | Drug | Hyaluronic acid and silver sulfadiazine |
Primary outcome
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: 1. < 50% 2. > 50% 3. 100% (complete healing)
3 secondary outcomes
Burning and pain
Time frame: From baseline to visit 3 (40 days after the start of the treatment)
Itching
Time frame: From baseline to visit 3 (40 days after the start of the treatment)
Bowel movements
Time frame: At visit 3 (40 days after the start of the treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Derived from this study: PubMed 42334667Deidda 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deidda principal investigator
University of Cagliari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gel containing a Propionibacterium extract and Hyaluronic acid and silver sulfadiazine in people with Anus Diseases and Gastrointestinal Diseases, run by University of Cagliari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of epithelialization (time frame: From baseline to visit 3 (40 days after the start of the treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06872151, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.