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Dermabond Prineo Skin Closure System for Surgical Incisions (SSSID Trial)

Phase 1

Recruiting

Led By Mehrdad Mark Mofid, M.D.

Research Sponsored by Mehrdad Mark Mofid

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 days post operation, 7 days post operation, 14 days post operation, 28 days post operation, 42 days post operation

Awards & highlights

SSSID Trial Summary

This trial is testing a new surgical wound dressing made from two FDA-approved materials: SERI surgical silk scaffold and dermaFLEX medical adhesive. The new dressing will be compared to two current standard of care wound closure devices: Prineo Dermabond and 3M Steri-Strip. The study seeks to determine if the new silk dressing is more effective than the other two devices.

Eligible Conditions

Surgical Incisions

SSSID Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 days post operation, 7 days post operation, 14 days post operation, 28 days post operation, 42 days post operation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 days post operation, 7 days post operation, 14 days post operation, 28 days post operation, 42 days post operation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 days post operation, 7 days post operation, 14 days post operation, 28 days post operation, 42 days post operation for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Dermatitis

Secondary outcome measures

Wound Dressing Detachment

Other outcome measures

Presence of Infection

SSSID Trial Design

1Treatment groups

Experimental Treatment

Group I: Surgical IncisionExperimental Treatment3 Interventions

Abdominoplasty Surgical Incision, Breast Reduction Surgical Incision, Mastopexy Surgical Incision, or Belt Lipectomy Surgical Incision

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Mehrdad Mark MofidLead Sponsor

Mehrdad Mark Mofid, M.D.Principal InvestigatorSan Diego Skin

Frequently Asked Questions

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

Has the Dermabond Prineo Skin Closure System been approved by the FDA?

"Our team at Power has rated the safety of Dermabond Prineo Skin Closure System with a 1 on a scale from 1 to 3 due to its limited evidence of efficacy and security during Phase 1 trials."

Answered by AI

Does this research endeavor have room for additional participants?

"Based on information from clinicaltrials.gov, this research is still accepting participants. It was announced to the public on August 23rd 2022 and has gone through a few updates since then, with the latest being published on August 25th 2022."

Answered by AI

How many individuals are engaging in this research endeavor?

"Correct. The clinical trial's listings on the online database show that this research is still accepting participants, having first been posted on August 23rd 2022 and last updated two days later. One hundred individuals are being sought from a single site to participate in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Silk Scaffold Surgical Incision Dressing

Mehrdad Mark Mofid 2022. "Silk Scaffold Surgical Incision Dressing". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05508945.