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

Impact of Topical Antiadhesion Therapy on Wound Healing and Postoperative Pain After Anal Surgery: A Randomized Double-blinded Controlled Study

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04275596

Enrollment

Registered

2020-02-19

Start date

2020-02-10

Completion date

2021-05-30

Last updated

2020-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Wound

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.

Interventions

DRUG2QR complex

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Time to complete anal Wound healing	Six weeks after surgery	The time required to achieve complete Complete epithelization of the anal wound postoperatively

Secondary

Measure	Time frame	Description
Anal pain	one week, one month, two months after surgery	pain assessed using visual analogue scale from 0-10

Countries

Egypt

Contacts

Primary ContactSameh H Emile, M.D.

sameh200@hotmail.com+201006267150

Backup ContactSameh H Emile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026