Back to resultsImpact of Topical Antiadhesion Therapy on Wound Healing and Postoperative Pain After Anal Surgery
Primary Purpose
Anal Wound
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
2QR complex
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Anal Wound
Eligibility Criteria
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.
Sites / Locations
- Mansoura university hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
2QR complex
Placebo
Arm Description
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
Outcomes
Primary Outcome Measures
Time to complete anal Wound healing
The time required to achieve complete Complete epithelization of the anal wound postoperatively
Secondary Outcome Measures
Anal pain
pain assessed using visual analogue scale from 0-10
Full Information
NCT ID
NCT04275596
First Posted
February 16, 2020
Last Updated
February 18, 2020
Sponsor
Mansoura University
1. Study Identification
Unique Protocol Identification Number
NCT04275596
Brief Title
Impact of Topical Antiadhesion Therapy on Wound Healing and Postoperative Pain After Anal Surgery
Official Title
Impact of Topical Antiadhesion Therapy on Wound Healing and Postoperative Pain After Anal Surgery: A Randomized Double-blinded Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
March 30, 2021 (Anticipated)
Study Completion Date
May 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Wound
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
2QR complex
Arm Type
Active Comparator
Arm Description
Patients who undergo anal surgery will apply 2QR complex topical agent on the wound until healing
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
Patients who undergo anal surgery will apply placebo cream on the wound until healing
Intervention Type
Drug
Intervention Name(s)
2QR complex
Intervention Description
Application of topical gel containing 2QR complex on the anal wound until complete wound healing
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Application of topical placebo on the anal wound until complete wound healing
Primary Outcome Measure Information:
Title
Time to complete anal Wound healing
Description
The time required to achieve complete Complete epithelization of the anal wound postoperatively
Time Frame
Six weeks after surgery
Secondary Outcome Measure Information:
Title
Anal pain
Description
pain assessed using visual analogue scale from 0-10
Time Frame
one week, one month, two months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sameh H Emile, M.D.
Phone
+201006267150
Email
sameh200@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sameh H Emile
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh H Emile, M.D.
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university hospital
City
Mansourah
State/Province
Dakahlia
ZIP/Postal Code
35516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sameh Emile, M.D
Phone
01006267150
Email
sameh200@hotmail.com
First Name & Middle Initial & Last Name & Degree
Sameh H Emile, M.D.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Impact of Topical Antiadhesion Therapy on Wound Healing and Postoperative Pain After Anal Surgery
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