body surface injury
Conditions
Interventions
Experimental group :light-curable adhesives
Control group :Tissue adhesive
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Gender is not limited, age 18-65 years old; 2. Subjects need to suture of surgical incision or emergency wound , and the longest diameter of the wound is less than or equal to 5cm; 3. The subjects can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to conduct follow-up evaluations in accordance with the requirements of the verification protocol.
Exclusion criteria
Exclusion criteria: 1. Skin trauma accompanied by skin defect, deep nerve injury, vascular injury and fracture; 2. Severe soft tissue contusion at the trauma site; 3. The wound site is infected, or the pollution is serious, and the possibility of infection is high; 4. If the trauma time exceeds 8 hours, the first-stage suture opportunity will be lost; 5. The length of the wound exceeds 5 cm, or the wound margin is irregular, or the skin wound with high tension such as the active large joint; 6. Serious condition is life-threatening; 7. Severe heart, liver, kidney, pulmonary insufficiency and other diseases; 8. Diabetes, malnutrition, uncontrolled hypertension, autoimmune diseases and other diseases that affect wound healing; 9. Mental illness, including severe hysteria, and lack of autonomy; 10. Pregnant or lactating women, or women planning to become pregnant; 11. Have stroke or diseases such as limb skin autonomic dysfunction; 12. During severe and difficult to control local or systemic acute or chronic infection; 13. Subjects allergic to product ingredients; 14. Subjects with bleeding constitution; 15. Subjects with chronic wounds at the site of product use, such as venous ulcers, arterial ulcers, diabetic ulcers, traumatic ulcers or pressure ulcers; 16. Use other hemostatic materials such as gelatin sponge, cellulose materials, and fibrin glue at the product use site; 17. Participated in other clinical trials in the last 3 months; 18. Drug or alcohol abusers within the past 3 months; 19. Subject with any medical history that, in the judgment of the investigator, may interfere with the results of the trial or increase the risk of the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The success rate of non-dehiscence of wound 7 days after operation;Photocuring effect of photocuring machine; | — |
Secondary
| Measure | Time frame |
|---|---|
| The success rate of non-dehiscence wounds and the quality of wound healing in other postoperative visits; | — |
Countries
China
Contacts
Public ContactZhaofan Xia
Outcome results
None listed