Prospective Randomized Control Study of Stratafix Vs. Standard-of-care for Deep Tissue Closure in Orthopaedic Surgery

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004190

Enrollment

220

Registered

2019-08-12

Start date

2019-09-04

Completion date

Unknown

Last updated

2019-10-07

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

Conditions

None listed

Interventions

Medical Device : Conventional Interrupted Knotted Suture Technique is used in standard management of deep fascia sutures in orthopedic surgical windows using conventional sutures. The purpose of this

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All of the following selection criteria must be met. ? After the explanation of the study, the agreement sign signed by an adult male between 18 and 80 years old. ? A person who understands and agrees voluntarily about matters related to research. ? Subjects eligible to visit the medical facility in accordance with the study protocol. ? Those who can speak and understand Korean proficiently. ? If a woman is not pregnant and is not breastfeeding,. ? The subjects to whom the research institute would like to undergo orthopedic surgery ? Subjects with a BMI less than 40 kg / m2.

Exclusion criteria

Exclusion criteria: ? Subjects with a BMI greater than 40 kg / m2 ? Subjects with a history of bleeding-related disease ? After the explanation of the study, the person who is under 18 years old at the time of signing the agreement or who is over 80 years old ? Subject to inmate ? People with mental illness who are difficult to understand about research-related matters ? In the interpretation of the results of the study, Subjects who did not seem to be able to follow up for meaningful results ? Subjects diagnosed with significant infectious collagen disease (Scleroderma) or other diseases associated with wound healing ? Patients who underwent radiation therapy at the orthopedic surgical site for 6 months or who underwent systemic chemotherapy ? Patients with a history of keloid or hypertrophic wounds or family history

Design outcomes

Primary

Measure	Time frame
Deep Surgical Open wound Suture Time (minute);Deep Surgical Open wound length(centimeter);Number of Sutures used in Deep Surgical Open Wound;Supericial Surgical Site Infection;Deep Surgical Site Infection;Organ/Space Surgical Site Infection;Surgical Site redness, swelling, exudate, hematoma;Surgical Wound Dehiscence	—

Secondary

Measure	Time frame
Total Operation Time(minute)	—

Countries

Korea, Republic of

Contacts

Public ContactYongjin Cho

Chosun University Hospital

choisidoru@gmail.com+82-62-220-3147

Outcome results