The Application of Photosensitive Hydrogel in Intranasal Endoscopic Dacryocystorhinostomy

NCT ID: NCT06551766

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2024-12-31

Brief Summary

To study the effect of Photosensitive hydrogel used for suture free anastomosis of lacrimal cyst and nasal mucoperiosteal flap in endoscopic nasal dacryocystostomy, and evaluate its adhesion to lacrimal cyst and nasal mucoperiosteal flap, promoting wound healing, forming a good anastomosis, preventing postoperative anastomosis and shortening operation time. Twenty patients with chronic dacryocystitis were randomly divided into photosensitive hydrogel group and suture group.Symptoms and nasal endoscopy were followed up 2, 6, and 12 weeks after surgery for both groups. And also adverse events were recorded at each follow-up.

Detailed Description

After endoscopic dacryocystonasal anastomosis, granulation and/or cicatricial adhesion are the main reasons for surgical failure. How to achieve the ideal fit between the lacrimal sac flap and the nasal mucoperiosteal flap and avoid the proliferation of granulation and cicatricial adhesion is very important for the success of the operation. In this study, "photocoupling reaction" technology was used to achieve seamless integration and strong adhesion of photosensitive hydrogel materials to the wound, and the photohydrogel was applied to suture free adhesion and wound repair of the lacrimal cyst mucosal flap and nasal mucosal flap in endoscopic nasal Dacryocystostomy (En-DCR), and its feasibility, safety and effectiveness were evaluated.

Conditions

Chronic Dacryocystitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Photosensitive hydrogel

The photosensitive hydrogel is composed of tetra-armed poly(ethylene glycol) (4aPEGNB)and methacrylate-modified hyaluronic acid (HAMA).The hydrogel can be rapidly photocured under light induction at 395nm.

Group Type: EXPERIMENTAL

Photosensitive hydrogel

Intervention Type: DEVICE

In the photosensitive hydrogel group, the anastomosis of the lacrimal cyst mucosal flap and the nasal mucoperiosteal flap was achieved by photosensitive hydrogel.

Suture fixation

The suture is fixed with 6-0 absorbable thread.

Group Type: ACTIVE_COMPARATOR

6-0 absorbable stitches

Intervention Type: DEVICE

In the suture fixation group, the anastomosis of the lacrimal cyst mucosal flap and the nasal mucoperiosteal flap was achieved by two stitches using 6-0 absorbable wire.

Interventions

Photosensitive hydrogel

In the photosensitive hydrogel group, the anastomosis of the lacrimal cyst mucosal flap and the nasal mucoperiosteal flap was achieved by photosensitive hydrogel.

Intervention Type: DEVICE

6-0 absorbable stitches

In the suture fixation group, the anastomosis of the lacrimal cyst mucosal flap and the nasal mucoperiosteal flap was achieved by two stitches using 6-0 absorbable wire.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Voluntarily participate in this clinical study and sign the informed consent;

2. Gender is not limited, age 18-75 years old;

3. The patient had symptoms and signs of chronic dacryocystitis, and the results of lacrimal passage irrigation suggested that the lower rush and return or upper rush and lower return, accompanied by mucous or purulent discharge reflux;

4. Lacrimal duct angiography suggests nasolacrimal duct obstruction without lacrimal canaliculi and/or duct obstruction.

Exclusion Criteria

1. Age < 18 or > 75 years old;

2. Previous history of dacryocystonasal anastomosis;

3. Abnormal coagulation function;

4. Tumors of lacrimal passage, especially in patients with papilloma or malignant tumors;

5. in the acute dacryocystitis attack stage;

6. obvious scar constitution;

7. Complicated with serious nasal diseases, such as severe allergic rhinitis, chronic rhinosinusitis and nasal polyps, acute suppurative rhinosinusitis, severe atrophic rhinitis, and severe deviation of nasal septum;

8. Have serious heart, liver, kidney, lung and other basic diseases, can not tolerate general anesthesia;

9. Distance from the hospital, postoperative review is not convenient;

10. Participated in other clinical trials within the last 3 months;

11. Any medical history that the investigator determines may interfere with the test results or increase the patient's risk.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eye & ENT Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eye & ENT Hospital of Fudan University

Shanghai, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Tong Lin, MD

Role: primary

lintongwzmc@163.com

13585764906

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2023017

Identifier Type: -

Identifier Source: org_study_id