Impact of Topical Antiadhesion Therapy on Wound Healing and Postoperative Pain After Anal Surgery
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2020
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 10, 2020
CompletedFirst Submitted
Initial submission to the registry
February 16, 2020
CompletedFirst Posted
Study publicly available on registry
February 19, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2021
CompletedFebruary 19, 2020
February 1, 2020
1.1 years
February 16, 2020
February 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Time to complete anal Wound healing
The time required to achieve complete Complete epithelization of the anal wound postoperatively
Six weeks after surgery
Secondary Outcomes (1)
Anal pain
one week, one month, two months after surgery
Study Arms (2)
2QR complex
ACTIVE COMPARATORPatients who undergo anal surgery will apply 2QR complex topical agent on the wound until healing
Placebo
ACTIVE COMPARATORPatients who undergo anal surgery will apply placebo cream on the wound until healing
Interventions
Application of topical gel containing 2QR complex on the anal wound until complete wound healing
Eligibility Criteria
You may qualify if:
- Adult patients of either sex with simple anal fistula, chronic anal fissure, or grade III/IV hemorrhoids will be included.
You may not qualify if:
- Patients with other anal conditions, diabetic patients, patients under steroid or immunosuppressive therapy will be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura university hospital
Al Mansurah, Dakahlia Governorate, 35516, Egypt
Study Officials
- PRINCIPAL INVESTIGATOR
Sameh H Emile, M.D.
Mansoura University
Central Study Contacts
Sameh H Emile
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer of surgery
Study Record Dates
First Submitted
February 16, 2020
First Posted
February 19, 2020
Study Start
February 10, 2020
Primary Completion
March 30, 2021
Study Completion
May 30, 2021
Last Updated
February 19, 2020
Record last verified: 2020-02