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Enrolling by Invitation

NCT Number: NCT07078669

Dyed vs. Undyed Polyglactin Sutures in Cutaneous Surgery

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.

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Key information

Conditions

Wound Closure Suture Materials

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

WVU Medicine Waynesburg Dermatology

Waynesburg, Pennsylvania, 15370-7010, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients who are unable to give informed consent

Treatment and study plan

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

Primary outcomes

  1. Clinical Erythema Assessment scale

    Time frame: 2 weeks post-procedure

    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. Clinical Erythema Assessment scale

    Time frame: 4 weeks post-procedure

    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. Clinical Erythema Assessment scale

    Time frame: 3 months post-procedure

    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. Presence of Hypertrophic Scarring

    Time frame: 2 weeks post-procedure

    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.

  5. Presence of Hypertrophic Scarring

    Time frame: 4 weeks post-procedure

    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.

  6. Presence of Hypertrophic Scarring

    Time frame: 3 months post-procedure

    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.

  7. Presence of Suture Extrusion

    Time frame: 2 weeks post-procedure

    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.

  8. Presence of Suture Extrusion

    Time frame: 4 weeks post-procedure

    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.

  9. Presence of Suture Extrusion

    Time frame: 3 Months post-procedure

    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.

  10. Presence of Surgical Site Infection

    Time frame: 2 weeks post-procedure

    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.

  11. Presence of Surgical Site Infection

    Time frame: 4 weeks post-procedure

    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.

  12. Presence of Surgical Site Infection

    Time frame: 3 Months post-procedure

    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.

  13. Presence of Edema

    Time frame: 2 weeks post-procedure

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

  14. Presence of Edema

    Time frame: 4 weeks post-procedure

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

  15. Presence of Edema

    Time frame: 3 months post-procedure

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

  16. Presence of Wound Induration

    Time frame: 2 weeks post-procedure

    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.

  17. Presence of Wound Induration

    Time frame: 4 weeks post-procedure

    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.

  18. Presence of Wound Induration

    Time frame: 3 months post-procedure

    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.

  19. Presence of Hyperpigmentation

    Time frame: 2 weeks post-procedure

    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.

  20. Presence of Hyperpigmentation

    Time frame: 4 weeks post-procedure

    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.

  21. Presence of Hyperpigmentation

    Time frame: 3 months post-procedure

    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.

  22. Presence of Exudate

    Time frame: 2 weeks post-procedure

    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.

  23. Presence of Exudate

    Time frame: 4 weeks post-procedure

    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.

  24. Presence of Exudate

    Time frame: 3 months post-procedure

    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.

  25. Presence of Dehiscence

    Time frame: 2 weeks post-procedure

    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.

  26. Presence of Dehiscence

    Time frame: 4 weeks post-procedure

    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.

  27. Presence of Dehiscence

    Time frame: 3 months post-procedure

    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.

  28. Failure to Epithelialize

    Time frame: 2 weeks post-procedure

    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.

  29. Failure to Epithelialize

    Time frame: 4 weeks post-procedure

    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.

  30. Failure to Epithelialize

    Time frame: 3 months post-procedure

    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.

  31. Presence of Suture Granuloma

    Time frame: 2 weeks post-procedure

    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.

  32. Presence of Suture Granuloma

    Time frame: 4 weeks post-procedure

    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.

  33. Presence of Suture Granuloma

    Time frame: 3 months post-procedure

    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.

  34. Presence of Contact Dermatitis

    Time frame: 2 weeks post-procedure

    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.

  35. Presence of Contact Dermatitis

    Time frame: 4 weeks post-procedure

    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.

  36. Presence of Contact Dermatitis

    Time frame: 3 months post-procedure

    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.

  37. Patient-Rated Pruritus

    Time frame: 2 weeks post-procedure

    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.

  38. Patient-Rated Pruritus

    Time frame: 4 weeks post-procedure

    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.

  39. Patient-Rated Pruritus

    Time frame: 3 months post-procedure

    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.

  40. Patient-Rated Pain/Tenderness

    Time frame: 2 weeks post-procedure

    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.

  41. Patient-Rated Pain/Tenderness

    Time frame: 4 weeks post-procedure

    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.

  42. Patient-Rated Pain/Tenderness

    Time frame: 3 months post-procedure

    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.

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Registry information

Official study title

Comparison of Patient Outcomes With Dyed vs. Undyed Polyglactin Sutures in Cutaneous Surgery

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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