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

Mansoura University

Status and phase: Unknown; Phase 3

Conditions: Anal Wound

Treatments: Drug: 2QR complex; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04275596

Mansoura 123

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

2QR complex

Active Comparator group

Description:

Patients who undergo anal surgery will apply 2QR complex topical agent on the wound until healing

Treatment:

Drug: 2QR complex

Placebo

Active Comparator group

Description:

Patients who undergo anal surgery will apply placebo cream on the wound until healing

Treatment:

Drug: Placebo