Cutaneous Use of Tisuacryl®

Phase 3

• Conditions: Wounds and Injuries; Surgical and traumatic wonds

• Registration Number: RPCEC00000046
• Lead Sponsor: Center of Biomaterials of Havana University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 674

Inclusion Criteria

Patients of both genders, between 1 and 80 years old. Adult patients who gave the informed consent. Children whose parents or tutors signed the informed consent. Patients who fulfill the established diagnostic criteria:: 1)Surgical incisions less than 6 cm long which had subcutaneous sutures. Longer incisions could be considered using anchor sutures every 3-4 cm. 2)Recent (under 6 hours) non deep cutaneous lacerations (that do not require internal suture) less than 4 cm long and 0.5 cm in width.

Exclusion Criteria

Patients with wounds contaminated by any foreign body Patients with wounds produced by bites or scratch of animals or humans, puncture or crushing Patients with wounds located in an area of high skin tension Patients with mental incapacity and/or severe psychological disorders Pregnant and breastfeeding women Patients that do not consent to participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dehiscence, immediately and 7-11 days

Secondary Outcome Measures

Name	Time	Method
Infection, 7-11 days Patient Satisfaction, 7-11 days Physician Satisfaction, 7-11 days Cosmetic appearance of the scar, 30 days