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

NCT ID: NCT04275596

Last Updated: 2020-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-10

Study Completion Date

2021-05-30

Brief Summary

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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

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Conditions

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Anal Wound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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2QR complex

Patients who undergo anal surgery will apply 2QR complex topical agent on the wound until healing

Group Type ACTIVE_COMPARATOR

2QR complex

Intervention Type DRUG

Application of topical gel containing 2QR complex on the anal wound until complete wound healing

Placebo

Patients who undergo anal surgery will apply placebo cream on the wound until healing

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Application of topical placebo on the anal wound until complete wound healing

Interventions

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2QR complex

Application of topical gel containing 2QR complex on the anal wound until complete wound healing

Intervention Type DRUG

Placebo

Application of topical placebo on the anal wound until complete wound healing

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Sameh Emile

lecturer of surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sameh H Emile, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

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Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sameh H Emile, M.D.

Role: CONTACT

+201006267150

Sameh H Emile

Role: CONTACT

Facility Contacts

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Sameh Emile, M.D

Role: primary

01006267150

Sameh H Emile, M.D.

Role: backup

Other Identifiers

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Mansoura 123

Identifier Type: -

Identifier Source: org_study_id

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