NCT04275596|UnknownPhase 3
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Sponsor study identifier
interventional
50
1 country
1
Study Start
February 10, 2020
Actual (reported)Primary Completion
March 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 10, 2020
Actual (reported)February 16, 2020
Actual (reported)February 19, 2020
Actual (reported)March 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Time to complete anal Wound healing
The time required to achieve complete Complete epithelization of the anal wound postoperatively
Six weeks after surgery
Anal pain
one week, one month, two months after surgery
Patients who undergo anal surgery will apply 2QR complex topical agent on the wound until healing
Patients who undergo anal surgery will apply placebo cream on the wound until healing
Application of topical gel containing 2QR complex on the anal wound until complete wound healing
Application of topical placebo on the anal wound until complete wound healing
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Mansoura university hospital
Al Mansurah, Dakahlia Governorate, 35516, Egypt
Sameh H Emile, M.D.
Mansoura University
Sameh H Emile
CONTACT
First Submitted
February 16, 2020
First Posted
February 19, 2020
Study Start
February 10, 2020
Actual (reported)Primary Completion
March 30, 2021
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 30, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 19, 2020
Record last verified: 2020-02
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Source: ClinicalTrials.gov.
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