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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04275596
Recruitment Status : Recruiting
First Posted : February 19, 2020
Last Update Posted : February 19, 2020
Information provided by (Responsible Party):
Sameh Emile, 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.

Condition or disease Intervention/treatment Phase
Anal Wound Drug: 2QR complex Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Topical Antiadhesion Therapy on Wound Healing and Postoperative Pain After Anal Surgery: A Randomized Double-blinded Controlled Study
Actual Study Start Date : February 10, 2020
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 2QR complex
Patients who undergo anal surgery will apply 2QR complex topical agent on the wound until healing
Drug: 2QR complex
Application of topical gel containing 2QR complex on the anal wound until complete wound healing

Active Comparator: Placebo
Patients who undergo anal surgery will apply placebo cream on the wound until healing
Drug: Placebo
Application of topical placebo on the anal wound until complete wound healing

Primary Outcome Measures :
  1. Time to complete anal Wound healing [ Time Frame: Six weeks after surgery ]
    The time required to achieve complete Complete epithelization of the anal wound postoperatively

Secondary Outcome Measures :
  1. Anal pain [ Time Frame: one week, one month, two months after surgery ]
    pain assessed using visual analogue scale from 0-10

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04275596

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Contact: Sameh H Emile, M.D. +201006267150
Contact: Sameh H Emile

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Mansoura university hospital Recruiting
Mansourah, Dakahlia, Egypt, 35516
Contact: Sameh Emile, M.D    01006267150   
Contact: Sameh H Emile, M.D.         
Sponsors and Collaborators
Mansoura University
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Principal Investigator: Sameh H Emile, M.D. Mansoura University
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Responsible Party: Sameh Emile, lecturer of surgery, Mansoura University Identifier: NCT04275596    
Other Study ID Numbers: Mansoura 123
First Posted: February 19, 2020    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Wounds and Injuries
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms