Dyed vs. Undyed Polyglactin Sutures in Cutaneous Surgery

Part of paid clinical trials in Waynesburg, Pennsylvania.

Sponsor
West Virginia University
Study ID
NCT07078669
Status
Enrolling By Invitation

Conditions

  • Suture Materials
  • Wound Closure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Polyglactin 910 (Dyed) — DEVICE
    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.
  • Polyglactin 910 (Undyed) — DEVICE
    Half the wound for each participant will be sutured using Polyglactin 910 suture Undyed

Study Details

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.

Key Dates

Start date
Aug 31, 2025
Status verified
Jul 2025
Primary completion
Jan 31, 2026
Completion
Jan 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dyed Sutures
    Polyglactin 910 (Vicryl) is an absorbable suture commonly utilized for cutaneous surgery; it is available in both dyed (violet) and undyed forms. This arm designates the Dyed Sutures.
  • Active Comparator: Undyed Sutures
    Polyglactin 910 (Vicryl) is an absorbable suture commonly utilized for cutaneous surgery; it is available in both dyed (violet) and undyed forms. This arm designates the Undyed Sutures.

Primary Outcome Measure

Clinical Erythema Assessment scale [ Time Frame: 2 weeks post-procedure ]

Locations (1)

FacilityCityStateZIPSite coordinators
WVU Medicine Waynesburg DermatologyWaynesburgPennsylvania15370-7010-

Find similar trials in Waynesburg, PA

By research site
WVU Medicine Waynesburg Dermatology· Waynesburg, PA

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