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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.
 
ClinicalTrials.gov Identifier: NCT04275596
Recruitment Status : Recruiting
First Posted : February 19, 2020
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Sameh Emile, Mansoura University

Tracking Information
First Submitted Date  ICMJE February 16, 2020
First Posted Date  ICMJE February 19, 2020
Last Update Posted Date February 19, 2020
Actual Study Start Date  ICMJE February 10, 2020
Estimated Primary Completion Date March 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2020)
Anal pain [ Time Frame: one week, one month, two months after surgery ]
pain assessed using visual analogue scale from 0-10
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Topical Antiadhesion Therapy on Wound Healing and Postoperative Pain After Anal Surgery
Official Title  ICMJE Impact of Topical Antiadhesion Therapy on Wound Healing and Postoperative Pain After Anal Surgery: A Randomized Double-blinded Controlled Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Anal Wound
Intervention  ICMJE
  • Drug: 2QR complex
    Application of topical gel containing 2QR complex on the anal wound until complete wound healing
  • Drug: Placebo
    Application of topical placebo on the anal wound until complete wound healing
Study Arms  ICMJE
  • Active Comparator: 2QR complex
    Patients who undergo anal surgery will apply 2QR complex topical agent on the wound until healing
    Intervention: Drug: 2QR complex
  • Active Comparator: Placebo
    Patients who undergo anal surgery will apply placebo cream on the wound until healing
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 18, 2020)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2021
Estimated Primary Completion Date March 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sameh H Emile, M.D. +201006267150 sameh200@hotmail.com
Contact: Sameh H Emile
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04275596
Other Study ID Numbers  ICMJE Mansoura 123
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sameh Emile, Mansoura University
Study Sponsor  ICMJE Mansoura University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sameh H Emile, M.D. Mansoura University
PRS Account Mansoura University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP