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Comparator was not available in the planned setting
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| Name | Class |
|---|---|
| B.Braun Surgical SA | INDUSTRY |
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The aim of this study is to show that the performance of Novosyn® Quick suture material is comparable with standard suture material used in Ophthalmic surgery. In order to show that, various safety and efficacy parameters have been selected. The outcome regarding these parameters will be compared in 2 treatment groups. Active control group will receive Vicryl® Rapide and the treatment group Novosyn® Quick for ophthalmic surgery. It was decided to design this study as a randomized trial, because limited clinical evidence is available in the literature for the active control group (Vicryl® Rapide) which can be used for comparison. Eye operation will be randomly allocated on the left and right side (1:1) to both treatment groups.
Patients undergoing elective, primary ophthalmic surgery (dacryocystorhinostomy, ectropion, entropion, ptosis, eyelid tumor resection, blepharoplasty)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novosyn® Quick | Experimental | Eye surgery using suture material |
|
| Vicryl® Rapid | Active Comparator | Eye surgery using suture material |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novosyn® Quick | Device | Eye surgery |
| |
| Vicryl® Rapid |
| Measure | Description | Time Frame |
|---|---|---|
| Wound infection rate | Wound infection (Surgical site infection, SSI) is defined according to the definition of the US Centres for Disease Control and Prevention (CDC). | 3 months |
| Incidence of Wound dehiscence | A dehiscence of the skin which needs surgical treatment with re-closure | until 3 months post-operatively |
| Incidence of Tissue reaction (inflammation) | A tissue reaction (inflammation) due to the suture material | until 3 months after surgery |
| Incidence of Suture removal due to adverse events | until 3 months post-operatively | |
| Incidence of Re-suturing due to dehiscence | until 3 months post-operatively | |
| Cumulated frequency of adverse events | (edema, allergic reaction, ulceration, bleeding, granuloma, swelling, recurrence, reoperation, dry eyes) | until 3 months postoperatively |
| Pain (VAS) | until 3 months postoperatively | |
| Discomfort (VAS) | until 3 months postoperatively | |
| Scar formation (VAS) | until 3 months postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Can Misses | Ibiza Town | Balearic Islands | 07800 | Spain |
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| ID | Term |
|---|---|
| D004483 | Ectropion |
| D004774 | Entropion |
| D001763 | Blepharoptosis |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
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| Device |
Eye surgery |
|
| Patient satisfaction (VAS) | until 3 months postoperatively |
| Patient satisfaction (EQ-5D-5L) | until 3 months postoperatively |
| Cosmetic Result (VAS) | until 3 months postoperatively |
| Handling of the suture | Assessment of the handling of the suture material intra-operatively using a questionnaire including different dimensions (knot security, tensile strength, knot run down, tissue drag etc.) with 5 evaluations levels (excellent, very good, good, satisfied, poor). | Intraoperative |