Suture Materials, Wound Closure
Conditions
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.
Interventions
DEVICEPolyglactin 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.
DEVICEPolyglactin 910 (Undyed)
Half the wound for each participant will be sutured using Polyglactin 910 suture Undyed
Sponsors
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are scheduled for a standard of care surgical excision
Exclusion criteria
* Patients who are unable to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Erythema Assessment scale | 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. |
| Presence of Surgical Site Infection | 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. |
| Presence of Hypertrophic Scarring | 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. |
| Presence of Suture Extrusion | 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. |
| Presence of Edema | 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. |
| Presence of Wound Induration | 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. |
| Presence of Hyperpigmentation | 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. |
| Presence of Exudate | 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. |
| Presence of Dehiscence | 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. |
| Failure to Epithelialize | 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. |
| Presence of Suture Granuloma | 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. |
| Presence of Contact Dermatitis | 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. |
| Patient-Rated Pruritus | 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. |
| Patient-Rated Pain/Tenderness | 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. |
Countries
United States
Outcome results
None listed