Dyed vs. Undyed Polyglactin Sutures in Cutaneous Surgery

NCT07078669 | Enrolling By Invitation FDA Device

• 1 other identifier: 2504138740
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (42)

• Clinical Erythema Assessment scale

  Erythema will be assessed on both sides of the surgical wound using a 0-4 Clinical Erythema Assessment scale: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe with 0 being the better outcome and 4 the worst.

  2 weeks post-procedure

• Clinical Erythema Assessment scale

  Erythema will be assessed on both sides of the surgical wound using a 0-4 Clinical Erythema Assessment scale: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe with 0 being the better outcome and 4 the worst.

  4 weeks post-procedure

• Clinical Erythema Assessment scale

  Erythema will be assessed on both sides of the surgical wound using a 0-4 Clinical Erythema Assessment scale: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe with 0 being the better outcome and 4 the worst.

  3 months post-procedure

• Presence of Hypertrophic Scarring

  Percentage of the presence of hypertrophic scarring. Visual clinical assessment of each side of the wound will document the presence or absence of hypertrophic scarring (yes/no). A lower percentage of presence of hypertrophic scarring is better than higher.

  2 weeks post-procedure

• Presence of Hypertrophic Scarring

  Percentage of the presence of hypertrophic scarring. Visual clinical assessment of each side of the wound will document the presence or absence of hypertrophic scarring (yes/no). A lower percentage of presence of hypertrophic scarring is better than higher.

  4 weeks post-procedure

• Presence of Hypertrophic Scarring

  Percentage of the presence of hypertrophic scarring. Visual clinical assessment of each side of the wound will document the presence or absence of hypertrophic scarring (yes/no). A lower percentage of presence of hypertrophic scarring is better than higher.

  3 months post-procedure

• Presence of Suture Extrusion

  Presence of Suture Extrusion: Wound evaluation will record whether sutures are visibly extruding from the skin (yes/no) on each side of the wound, to compare extrusion frequency (percentage of suture extrusion being present) between suture types.

  2 weeks post-procedure

• Presence of Suture Extrusion

  Presence of Suture Extrusion: Wound evaluation will record whether sutures are visibly extruding from the skin (yes/no) on each side of the wound, to compare extrusion frequency (percentage of suture extrusion being present) between suture types.

  4 weeks post-procedure

• Presence of Suture Extrusion

  Presence of Suture Extrusion: Wound evaluation will record whether sutures are visibly extruding from the skin (yes/no) on each side of the wound, to compare extrusion frequency (percentage of suture extrusion being present) between suture types.

  3 Months post-procedure

• Presence of Surgical Site Infection

  Presence of Surgical Site Infection: Wound will be evaluated for signs of infection (e.g. erythema, exudate, tenderness) and recorded as yes/no to compare infection frequency (percentage of infection being present) between suture types.

  2 weeks post-procedure

• Presence of Surgical Site Infection

  Presence of Surgical Site Infection: Wound will be evaluated for signs of infection (e.g. erythema, exudate, tenderness) and recorded as yes/no to compare infection frequency (percentage of infection being present) between suture types.

  4 weeks post-procedure

• Presence of Surgical Site Infection

  Presence of Surgical Site Infection: Wound will be evaluated for signs of infection (e.g. erythema, exudate, tenderness) and recorded as yes/no to compare infection frequency (percentage of infection being present) between suture types.

  3 Months post-procedure

• Presence of Edema

  Presence of Edema: Wound will be evaluated for signs of edema and recorded as yes/no to compare frequency of presence between suture types.

  2 weeks post-procedure

• Presence of Edema

  Presence of Edema: Wound will be evaluated for signs of edema and recorded as yes/no to compare frequency of presence between suture types.

  4 weeks post-procedure

• Presence of Edema

  Presence of Edema: Wound will be evaluated for signs of edema and recorded as yes/no to compare frequency of presence between suture types.

  3 months post-procedure

• Presence of Wound Induration

  Presence of Wound Induration: Wound will be evaluated for signs of edema and recorded as yes/no to compare frequency of presence between suture types.

  2 weeks post-procedure

• Presence of Wound Induration

  Presence of Wound Induration: Wound will be evaluated for signs of edema and recorded as yes/no to compare frequency of presence between suture types.

  4 weeks post-procedure

• Presence of Wound Induration

  Presence of Wound Induration: Wound will be evaluated for signs of edema and recorded as yes/no to compare frequency of presence between suture types.

  3 months post-procedure

• Presence of Hyperpigmentation

  Presence of Hyperpigmentation: Visual observation will determine whether increased pigmentation is present at the wound site and recorded as yes/no to compare frequency of presence between suture types.

  2 weeks post-procedure

• Presence of Hyperpigmentation

  Presence of Hyperpigmentation: Visual observation will determine whether increased pigmentation is present at the wound site and recorded as yes/no to compare frequency of presence between suture types.

  4 weeks post-procedure

• Presence of Hyperpigmentation

  Presence of Hyperpigmentation: Visual observation will determine whether increased pigmentation is present at the wound site and recorded as yes/no to compare frequency of presence between suture types.

  3 months post-procedure

• Presence of Exudate

  Presence of Exudate: Each side of the wound (dyed and undyed) will be checked for exudate (fluid drainage) and recorded as yes/no to assess differences in wound response.

  2 weeks post-procedure

• Presence of Exudate

  Presence of Exudate: Each side of the wound (dyed and undyed) will be checked for exudate (fluid drainage) and recorded as yes/no to assess differences in wound response.

  4 weeks post-procedure

• Presence of Exudate

  Presence of Exudate: Each side of the wound (dyed and undyed) will be checked for exudate (fluid drainage) and recorded as yes/no to assess differences in wound response.

  3 months post-procedure

• Presence of Dehiscence

  Presence of Dehiscence: Each side of the wound (dyed and undyed) will be checked for dehiscence (any separation or opening) at the site of closure and recorded as yes/no to compare frequency of presence between suture types.

  2 weeks post-procedure

• Presence of Dehiscence

  Presence of Dehiscence: Each side of the wound (dyed and undyed) will be checked for dehiscence (any separation or opening) at the site of closure and recorded as yes/no to compare frequency of presence between suture types.

  4 weeks post-procedure

• Presence of Dehiscence

  Presence of Dehiscence: Each side of the wound (dyed and undyed) will be checked for dehiscence (any separation or opening) at the site of closure and recorded as yes/no to compare frequency of presence between suture types.

  3 months post-procedure

• Failure to Epithelialize

  Failure to Epithelialize: Each side of the wound (dyed and undyed) will be evaluated for failure to epithelialize (incomplete skin coverage) and recorded as yes/no to compare differences between suture types.

  2 weeks post-procedure

• Failure to Epithelialize

  Failure to Epithelialize: Each side of the wound (dyed and undyed) will be evaluated for failure to epithelialize (incomplete skin coverage) and recorded as yes/no to compare differences between suture types.

  4 weeks post-procedure

• Failure to Epithelialize

  Failure to Epithelialize: Each side of the wound (dyed and undyed) will be evaluated for failure to epithelialize (incomplete skin coverage) and recorded as yes/no to compare differences between suture types.

  3 months post-procedure

• Presence of Suture Granuloma

  Presence of Suture Granuloma: Granuloma formation at the suture site will be visually identified and recorded as yes/no. Comparison will be made between dyed and undyed sides.

  2 weeks post-procedure

• Presence of Suture Granuloma

  Presence of Suture Granuloma: Granuloma formation at the suture site will be visually identified and recorded as yes/no. Comparison will be made between dyed and undyed sides.

  4 weeks post-procedure

• Presence of Suture Granuloma

  Presence of Suture Granuloma: Granuloma formation at the suture site will be visually identified and recorded as yes/no. Comparison will be made between dyed and undyed sides.

  3 months post-procedure

• Presence of Contact Dermatitis

  Presence of Contact Dermatitis: Contact dermatitis will be assessed and graded on a standardized International Contact Dermatitis Research Group (ICDRG) grading scale: - (none), + (weak), ++ (strong), +++ (extreme), IR (irritant) with none being the best outcome. The grading will be used to compare reactions between the two suture types.

  2 weeks post-procedure

• Presence of Contact Dermatitis

  Presence of Contact Dermatitis: Contact dermatitis will be assessed and graded on a standardized International Contact Dermatitis Research Group (ICDRG) grading scale: - (none), + (weak), ++ (strong), +++ (extreme), IR (irritant) with none being the best outcome. The grading will be used to compare reactions between the two suture types.

  4 weeks post-procedure

• Presence of Contact Dermatitis

  Presence of Contact Dermatitis: Contact dermatitis will be assessed and graded on a standardized International Contact Dermatitis Research Group (ICDRG) grading scale: - (none), + (weak), ++ (strong), +++ (extreme), IR (irritant) with none being the best outcome. The grading will be used to compare reactions between the two suture types.

  3 months post-procedure

• Patient-Rated Pruritus

  Patient-Rated Pruritus: Patient will rate itch severity on each side of the wound using a 0-3 scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe with 0=none being the better outcome.

  2 weeks post-procedure

• Patient-Rated Pruritus

  Patient-Rated Pruritus: Patient will rate itch severity on each side of the wound using a 0-3 scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe with 0=none being the better outcome.

  4 weeks post-procedure

• Patient-Rated Pruritus

  Patient-Rated Pruritus: Patient will rate itch severity on each side of the wound using a 0-3 scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe with 0=none being the better outcome.

  3 months post-procedure

• Patient-Rated Pain/Tenderness

  Patient-Rated Pruritus: Patients will rate pain/tenderness on each side of the wound using a 0-3 scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe with 0=none being the better outcome.

  2 weeks post-procedure

• Patient-Rated Pain/Tenderness

  Patient-Rated Pruritus: Patients will rate pain/tenderness on each side of the wound using a 0-3 scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe with 0=none being the better outcome.

  4 weeks post-procedure

• Patient-Rated Pain/Tenderness

  Patient-Rated Pruritus: Patients will rate pain/tenderness on each side of the wound using a 0-3 scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe with 0=none being the better outcome.

  3 months post-procedure

Study Arms (2)

Dyed Sutures

ACTIVE COMPARATOR

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.

Device: Polyglactin 910 (Dyed)

Undyed Sutures

ACTIVE COMPARATOR

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.

Device: Polyglactin 910 (Undyed)

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.

Dyed Sutures

Polyglactin 910 (Undyed) DEVICE

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

Undyed Sutures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients who are unable to give informed consent

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

WVU Medicine Waynesburg Dermatology

Waynesburg, Pennsylvania, 15370-7010, United States

Location

Study Officials

• Sarah Camplbell, MD

  West Virginia University-Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 22, 2025
• Study Start: August 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)