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Dyed vs. Undyed Polyglactin Sutures in Cutaneous Surgery

NCT07078669 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-07-22

No results posted yet for this study

Summary

Purpose - This exploratory, split-wound study aims to evaluate the potential difference in skin reactions to two different types of sutures, dyed and undyed, used to close wounds after surgery. The study will assess whether dyed sutures to elicit increased tissue reactivity like redness, itching, and scarring and whether undyed sutures may be more optimal for wound healing and cosmetic response. Enrollment into the study and data collection is expected to take approximately 3-6 months. Follow-up visits will be chosen at 2 weeks, 4 weeks, and 3 months post-surgery, which is standard practice for monitoring healing and checking for complications such as infection or abnormal scarring.

Primary Objective - The primary objective is to assess the response of wounds closed with both dyed and undyed sutures after cutaneous surgery to determine if there is a difference in wound healing and tissue reactivity with one compared to the other.

Enrollment into the study and data collection is expected to take approximately 3-6 months. Follow-up visits will be chosen at 2 weeks, 4 weeks, and 3 months post-surgery, which is standard practice for monitoring healing and checking for complications such as infection or abnormal scarring.

Conditions

  • Wound Closure
  • Suture Materials

Interventions

DEVICE

Polyglactin 910 (Dyed)

Half the wound for each participant will be sutured using Polyglactin 910 suture dyed (violet) with colorants such as D\&C Violet No. 2 present.

DEVICE

Polyglactin 910 (Undyed)

Half the wound for each participant will be sutured using Polyglactin 910 suture Undyed

Sponsors & Collaborators

  • West Virginia University

    lead OTHER

Principal Investigators

  • Sarah Camplbell, MD · West Virginia University-Dermatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2026-01-31
Completion
2026-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07078669 on ClinicalTrials.gov