Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06550999
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Patient Satisfaction and Cosmetic Outcomes in Adhesive Strip Versus Suture Repair for Simple Facial Lacerations
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Patient Satisfaction and Cosmetic Outcomes in Adhesive Strip Versus Suture Repair for Simple Facial Lacerations A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There are a variety of techniques utilized to close lacerations including but not limited to traditional sutures staples adhesive strips and skin glue While closing open wounds and preventing infection are the primary goals of laceration repair physicians are also concerned with minimizing scar formation and providing the best cosmetic outcomes for the patient Specifically the skin on the face is a sensitive area where cosmetic outcome is of high importance and several laceration repair techniques have been devised for closing facial wounds
Sutures have traditionally been used to close wounds in various types of tissue and it is still very commonly used in the clinical setting Adhesive strips also known under the brand names of Steri-Strips Curi-strips Nichi-Strips and Suture Strips are another method to repair lacerations superficially Due to their superficial application and ease of use adhesive strips may help minimize scar formation and may result in less pain and complications for the patient when compared to conventional sutures
Therefore the aim of this study is to determine whether repair of small simple facial lacerations with adhesive strips results in better patient experiences and better cosmetic outcomes than sutures The investigators hypothesize that wounds repaired with adhesive strip will have higher patient satisfaction scores and better cosmetic outcomes
Sutures have traditionally been used to close wounds in various types of tissue and it is still very commonly used in the clinical setting Adhesive strips also known under the brand names of Steri-Strips Curi-strips Nichi-Strips and Suture Strips are another method to repair lacerations superficially Due to their superficial application and ease of use adhesive strips may help minimize scar formation and may result in less pain and complications for the patient when compared to conventional sutures
Therefore the aim of this study is to determine whether repair of small simple facial lacerations with adhesive strips results in better patient experiences and better cosmetic outcomes than sutures The investigators hypothesize that wounds repaired with adhesive strip will have higher patient satisfaction scores and better cosmetic outcomes
Detailed Description:
This is a prospective single-blinded randomized controlled trial taking place in a single center Patients will be identified in the emergency room as they present to the hospital and meet eligibility criteria Following informed consent patients will be randomized in a 11 ratio to either the adhesive strip repair or the suture repair group Randomization will be dictated by a validated online software utilizing the Wichmann-Hill random number generator A password-protected randomization database that is only accessible to the study team will be utilized
After randomization to their respective laceration repair group patients will be surveyed by the study team to assess their experience satisfaction and pain scores during the laceration repair Approximately two months after their initial laceration repair the patients will be contacted securely via phone call or email to assess if they had any complications and to assess their satisfaction and cosmetic rating of their laceration scar Additionally the subjects will be instructed to take pictures andor videos of their scar and send it securely to the study team via UCI Epic MyChart or a HIPAA-compliant encrypted email if MyChart is unavailable These photos and videos will be de-identified and stored securely on a password-encrypted folder where a blinded evaluator will score the scars with a validated scar assessment tool Patients will be instructed to only take photosvideos of their scar area and not any other major areas of their face that can be identified Following the conclusion of the study all patient identifiers and photosvideos will be destroyed to preserve patient privacy
All survey data will be collected and entered into a REDCap database Data collection will include demographics phoneemail contact information patient satisfaction scores with the laceration repair patient pain scores patient scar cosmetic rating presence of complications and patient responses to questions about their general experience during the laceration repair and healing time period
After randomization to their respective laceration repair group patients will be surveyed by the study team to assess their experience satisfaction and pain scores during the laceration repair Approximately two months after their initial laceration repair the patients will be contacted securely via phone call or email to assess if they had any complications and to assess their satisfaction and cosmetic rating of their laceration scar Additionally the subjects will be instructed to take pictures andor videos of their scar and send it securely to the study team via UCI Epic MyChart or a HIPAA-compliant encrypted email if MyChart is unavailable These photos and videos will be de-identified and stored securely on a password-encrypted folder where a blinded evaluator will score the scars with a validated scar assessment tool Patients will be instructed to only take photosvideos of their scar area and not any other major areas of their face that can be identified Following the conclusion of the study all patient identifiers and photosvideos will be destroyed to preserve patient privacy
All survey data will be collected and entered into a REDCap database Data collection will include demographics phoneemail contact information patient satisfaction scores with the laceration repair patient pain scores patient scar cosmetic rating presence of complications and patient responses to questions about their general experience during the laceration repair and healing time period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None