Dyed vs. Undyed Polyglactin Sutures in Cutaneous Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Polyglactin 910 (Dyed), Polyglactin 910 (Undyed).
- Who it may be relevant to
- Registry conditions: Wound Closure, Suture Materials. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Patient Outcomes With Dyed vs. Undyed Polyglactin Sutures in Cutaneous Surgery
Overview
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.
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
Primary outcome measures
- Clinical Erythema Assessment scale [Time frame: 2 weeks post-procedure]
- Clinical Erythema Assessment scale [Time frame: 4 weeks post-procedure]
- Clinical Erythema Assessment scale [Time frame: 3 months post-procedure]
- Presence of Hypertrophic Scarring [Time frame: 2 weeks post-procedure]
- Presence of Hypertrophic Scarring [Time frame: 4 weeks post-procedure]
- Presence of Hypertrophic Scarring [Time frame: 3 months post-procedure]
- Presence of Suture Extrusion [Time frame: 2 weeks post-procedure]
- Presence of Suture Extrusion [Time frame: 4 weeks post-procedure]
- Presence of Suture Extrusion [Time frame: 3 Months post-procedure]
- Presence of Surgical Site Infection [Time frame: 2 weeks post-procedure]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- WVU Medicine Waynesburg Dermatology — Waynesburg
Identifiers
NCT: NCT07078669 · 2504138740