Dyed vs. Undyed Polyglactin Sutures in Cutaneous Surgery

NCT ID: NCT07078669

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2026-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Polyglactin 910 (Dyed)

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Polyglactin 910 (Undyed)

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Polyglactin 910 (Undyed)

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients who are scheduled for a standard of care surgical excision

Exclusion Criteria

• Patients who are unable to give informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West Virginia University

OTHER

Sponsor Role: lead

Responsible Party

Sarah Campbell

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah Camplbell, MD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University-Dermatology

Locations

WVU Medicine Waynesburg Dermatology

Waynesburg, Pennsylvania, United States

Countries

United States

Other Identifiers

2504138740

Identifier Type: -

Identifier Source: org_study_id