Impact of Topical Antiadhesion Therapy on Wound Healing and Postoperative Pain After Anal Surgery

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Impact of Topical Antiadhesion Therapy on Wound Healing and Postoperative Pain After Anal Surgery: A Randomized Double-blinded Controlled Study

Conditions
-----------------
Anal Wound

Intervention / Treatment
-----------------
* Drug: 2QR complex
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2QR complex<br>Patients who undergo anal surgery will apply 2QR complex topical agent on the wound until healing | Drug: 2QR complex<br>* Application of topical gel containing 2QR complex on the anal wound until complete wound healing<br>|
| Active Comparator: Placebo<br>Patients who undergo anal surgery will apply placebo cream on the wound until healing | Drug: Placebo<br>* Application of topical placebo on the anal wound until complete wound healing<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete anal Wound healing | The time required to achieve complete Complete epithelization of the anal wound postoperatively | Six weeks after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anal pain | pain assessed using visual analogue scale from 0-10 | one week, one month, two months after surgery |