Anal Wound Clinical Trial
Official title:
Impact of Topical Antiadhesion Therapy on Wound Healing and Postoperative Pain After Anal Surgery: A Randomized Double-blinded Controlled Study
2QR-complex is a patented molecule extracted from Aloe vera barbadensis leaves that blocks
the adhesion of pathogenic microbes to human epithelial cells and tissues [9]. Anti-adhesion
therapy such as 2QR-complex has been suggested as an alternative to antibiotics in the
treatment of bacterial infections. 2QR-complex based products have already shown comparable
efficacy to antibiotics in treating mucosal infections such as bacterial vaginosis.
In the present study we aim to assess the efficacy of 2QR-complex in pain relief and
promotion of anal wound healing after anal surgery. We presumed that anal discomfort and
prolonged healing after surgery for anal fissure, fistula, and hemorrhoids may in part be due
to contamination of the wound with fecal bacteria that colonize at the surgical site.
Therefore, we assumed that the use of topical anti-adhesive 2QR-complex-based product may
serve to minimize this negative impact on wound healing.
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | May 30, 2021 |
| Est. primary completion date | March 30, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Adult patients of either sex with simple anal fistula, chronic anal fissure, or grade III/IV hemorrhoids will be included. Exclusion Criteria: - Patients with other anal conditions, diabetic patients, patients under steroid or immunosuppressive therapy will be excluded. |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Mansoura university hospital | Mansourah | Dakahlia |
| Lead Sponsor | Collaborator |
|---|---|
| Mansoura University |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to complete anal Wound healing | The time required to achieve complete Complete epithelization of the anal wound postoperatively | Six weeks after surgery | |
| Secondary | Anal pain | pain assessed using visual analogue scale from 0-10 | one week, one month, two months after surgery |