Comparing two gels for healing after hemorrhoid surgery
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 study is testing two different gels to see which one helps people heal better and feel less pain after hemorrhoid surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Cagliari Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Monserrato, Cagliari) |
| Trial ID | NCT06872151 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized controlled phase IV trial evaluates the effectiveness of two topical gels in promoting wound healing and symptom relief following open excisional hemorrhoidectomy. Participants will be randomly assigned to receive either a gel containing a Propionibacterium extract or a gel with hyaluronic acid and silver sulfadiazine. The study will assess the degree of epithelialization and relief from pain, itching, and burning at multiple time points post-surgery. The goal is to determine which gel is more effective in aiding recovery during the postoperative period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 who have undergone open excisional hemorrhoidectomy involving the removal of at least three groups.
Not a fit: Patients with conditions such as fecal incontinence, anorectal neoplasms, or those on immunosuppressive treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved healing and symptom relief for patients recovering from hemorrhoid surgery.
How similar studies have performed: Other studies have shown promising results with similar topical treatments for wound healing, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Monserrato, Cagliari
- Policlinico Universitario Monserrato "Duilio Casula" - AOU Cagliari — Monserrato, Cagliari, Italy (Recruiting)
Study contacts
- Principal investigator: Deidda — University of Cagliari
- Study coordinator: Simona Deidda
- Email: simona.deidda86@unica.it
- Phone: +39 3401212819
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.