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Tie-Over Bolster Dressing for Surgical Scars

N/A

Recruiting

Led By Daniel Eisen, MD

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial is testing a new way to close wounds to reduce scarring: using a special gauze to reduce tension around the wound.

Who is the study for?

This trial is for adults over 18 who are having surgery on their head or neck and can close the wound right away. They must be able to consent and come back for a check-up. It's not for those with small wounds, under 18s, prisoners, pregnant women, or those who don't understand English.Check my eligibility

What is being tested?

The study tests if adding a 'tie-over bolster dressing'—a special gauze stitched over regular stitches—on half of the surgical wound reduces scarring compared to just stitches alone.See study design

What are the potential side effects?

Potential side effects may include discomfort from the extra dressing, possible skin irritation at the bolster site, and rare chances of infection due to additional material on the wound.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Observer Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)

Secondary outcome measures

Complications or Adverse Events from Treatment

Patient Scar Assessment as measured by Patient Observer Scar Assessment Score (POSAS)

Width of Scar as measured using Trace-to-Tape Method

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Layered Closure with Tie-Over Bolster DressingExperimental Treatment1 Intervention

The other side of wound will have a cutaneous layer of sutures with the addition of a bolster dressing.

Group II: Layered ClosureActive Control1 Intervention

A cutaneous layer of sutures will be placed on one side of wound, as is standard of care.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor

911 Previous Clinical Trials

4,709,533 Total Patients Enrolled

8 Trials studying Scarring

383 Patients Enrolled for Scarring

Daniel Eisen, MDPrincipal InvestigatorUniversity of California, Davis - Dermatology

8 Previous Clinical Trials

431 Total Patients Enrolled

4 Trials studying Scarring

200 Patients Enrolled for Scarring

Media Library

Layered Closure with Tie-Over Bolster Dressing Clinical Trial Eligibility Overview. Trial Name: NCT05758168 — N/A

Scarring Research Study Groups: Layered Closure, Layered Closure with Tie-Over Bolster Dressing

Scarring Clinical Trial 2023: Layered Closure with Tie-Over Bolster Dressing Highlights & Side Effects. Trial Name: NCT05758168 — N/A

Layered Closure with Tie-Over Bolster Dressing 2023 Treatment Timeline for Medical Study. Trial Name: NCT05758168 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any capacity for individuals to be included in the experiment?

"Data hosted on clinicaltrials.gov reveals that this particular medical trial is currently not accepting participants, having last been amended on February 24th 2023. Despite this, there are still 102 trials looking for volunteers at present."

Answered by AI

Recent research and studies

Plastic and Reconstructive SurgeryJournal

A Randomized Controlled Trial of the Embrace Advanced Scar Therapy Device to Reduce Incisional Scar Formation

Longaker, Michael T., Rod J. Rohrich, Lauren Greenberg, Heather Furnas, Robert Wald, Vivek Bansal, Hisham Seify, et al.. 2014. “A Randomized Controlled Trial of the Embrace Advanced Scar Therapy Device to Reduce Incisional Scar Formation”. Plastic and Reconstructive Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/prs.0000000000000417.

clinicaltrials.govStudy

Aesthetic Outcome of Tie-over Bolster Application in Surgical Wounds

Daniel Eisen, MD 2023. "Aesthetic Outcome of Tie-over Bolster Application in Surgical Wounds". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05758168.