Cicatrix
Conditions
Keywords
Suture Comparison
Brief summary
This study is being carried out to assess equivalence of scar outcome for two absorbable sutures used for wound closure on the face in dermatologic surgery: rapidly absorbable polyglactin 910 (VicrylRapide™) and fast-absorbing plain gut (5-0 fast). This is important because absorbable sutures are commonly used in Mohs surgery for epidermal closure, yet there is no evidence indicating if any of the sutures above allow for a better cosmetic outcome (less erythema, edema, and scarring).
Detailed description
Prospective randomized controlled split-scar observer-blinded study. After dermatologic surgery on the face, surgeons have a choice between using non-absorbable or absorbable sutures for skin closure. A dermatologic surgeon favoring absorbable sutures for wound closure will consider many factors in material selection, including ease of manipulation, cost, and absorption time. However, there have been no randomized trials comparing the most important measure: aesthetic/cosmetic outcome. Study endpoint/outcome: use three validated scar assessment tools.
Interventions
PROCEDURESurgical wound closure with superficial absorbable sutures
Different superficial absorbable sutures will be used in the closure of skin wounds after Mohs surgery. No drugs or devices are being compared, only the two different absorbable sutures (Vicryl Rapide and Fast Absorbing Gut).
Sponsors
University of British Columbia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients who are over 18 years and are having Mohs surgery on the face.
Exclusion criteria
* Patients with surgical wounds less than 4cm in length * Patients requiring full thickness skin grafts for reconstruction * Patients who are unable to attend routine postoperative follow-up appointments * Patients who are receiving radiation therapy after surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Stony Brook Scar Evaluation Scale (SBSES) score (cosmetic outcome) | 6 months | In this study we will use three validated scar assessment tools (the Stony Brook Scar Evaluation Scale (SBSES) to assess scar width, height, color, cross-hatching and overall appearance, the Wound Evaluation Scale (WES) to rate scar stepoff, contour irregularity, scar width, edge inversion, and inflammation , and the Visual Analogue Scale (VAS)) to assess overall scar appearance. This will be done at the one-week, two-month and six-month post-operative follow-ups. |
| The Wound Evaluation Scale (WES) score (cosmetic outcome) | 6 months | In this study we will use three validated scar assessment tools (the Stony Brook Scar Evaluation Scale (SBSES) to assess scar width, height, color, cross-hatching and overall appearance, the Wound Evaluation Scale (WES) to rate scar stepoff, contour irregularity, scar width, edge inversion, and inflammation , and the Visual Analogue Scale (VAS)) to assess overall scar appearance. This will be done at the one-week, two-month and six-month post-operative follow-ups. |
| The Visual Analogue Scale (VAS) score (cosmetic outcome) | 6 months | In this study we will use three validated scar assessment tools (the Stony Brook Scar Evaluation Scale (SBSES) to assess scar width, height, color, cross-hatching and overall appearance, the Wound Evaluation Scale (WES) to rate scar stepoff, contour irregularity, scar width, edge inversion, and inflammation , and the Visual Analogue Scale (VAS)) to assess overall scar appearance. This will be done at the one-week, two-month and six-month post-operative follow-ups. |
Contacts
Primary ContactDavid M Zloty, MD
Backup ContactLuiz C Pantalena, MD, PhD
Outcome results
None listed