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

Phase 3

• Conditions: Anal Wound
• Interventions: Drug: 2QR complex; Drug: Placebo

• Registration Number: NCT04275596
• Lead Sponsor: Mansoura University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2020-02
• Study Start: 2020-02-10
• Study First Submitted: 2020-02-16
• Study First Submitted QC: 2020-02-18
• Last Update Submitted: 2020-02-18
• Study First Posted: 2020-02-19
• Last Update Posted: 2020-02-19
• Primary Completion: 2021-03-30
• Study Completion: 2021-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Adult patients of either sex with simple anal fistula, chronic anal fissure, or grade III/IV hemorrhoids will be included.

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Exclusion Criteria

• Patients with other anal conditions, diabetic patients, patients under steroid or immunosuppressive therapy will be excluded.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2QR complex	2QR complex	Patients who undergo anal surgery will apply 2QR complex topical agent on the wound until healing
Placebo	Placebo	Patients who undergo anal surgery will apply placebo cream on the wound until healing

Primary Outcome Measures

Name	Time	Method
Time to complete anal Wound healing	Six weeks after surgery	The time required to achieve complete Complete epithelization of the anal wound postoperatively

Secondary Outcome Measures

Name	Time	Method
Anal pain	one week, one month, two months after surgery	pain assessed using visual analogue scale from 0-10

Trial Locations

Locations (1)

Mansoura university hospital; 🇪🇬 Mansourah, Dakahlia, Egypt