A Randomized Controlled Trial Comparing Sutures vs Staples for High Tension Closures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Locations
- 2
- Primary Endpoint
- Scored cosmetic appearance by blinded physician
Study Overview
Brief Summary
The study aims to compare outcomes in patient comfort, cosmetic appearance, and complication rates between sutures and staples in high tension areas for closures of skin cancers excised in a dermatology clinic.
Detailed Description
I. Purpose, Background and Rationale A. Aim and Hypotheses
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Standard of care for epidermal wound closure in dermatology is generally considered to be sutures, however many specialties utilize staples due to their increased speed of closure. In particular, high tension wound areas within dermatology may be more suitable for closure with staples given their higher tensile strength when compared to sutures.
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The hypothesis is that for high tension areas:
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Staples will provide improved cosmetic outcomes compared with sutures along with a reduction in closure times.
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Patient comfort during the placement of staples, as well as the healing and removal process, will be no different than what patients with sutures experience.
B. Background and Significance
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Physician evaluating scars post closure will be blinded
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 and over
- •Willing to return to KU for follow up clinic visits on at least 2 occasions
- •Lesion location on high tension area as defined by: back, shoulder, scapula, elbow, scalp
- •Incisions between the lengths of 3cm to 12 cm
- •Skin pathology as defined by BCC, SCC, Melanoma
- •No known history of keloid or excessive scar formation
- •No known contraindication or skin sensitivity to suture or staple material
- •No contraindication to lidocaine with epinephrine
Exclusion Criteria
- •<18 years old
- •Non english speaking
- •Needs surrogate decision maker
Outcomes
Primary Outcomes
Scored cosmetic appearance by blinded physician
Time Frame: 6 months post procedure
A blinded physician will grade the cosmetic appearance of the scar using a visual analog scale and Vancouver scar scale
Scored cosmetic appearance by patient
Time Frame: 6 months post procedure
The patient will grade the cosmetic appearance of the scar using a visual analog scale
Patient self reported comfort with placement of either sutures or staples
Time Frame: at time of surgery
Patients will fill out a survey after either suture or staple placement to assess how comfortable placement of the sutures or staples was. They will be asked to rate questions related to their comfort on a scale of 1-10.
Patient self reported comfort with removal of either sutures or staples
Time Frame: 2 weeks after placement
Patients will fill out a survey after either suture or staple removal to assess how comfortable the removal of the sutures or staples was. They will be asked to rate questions related to their comfort on a scale of 1-10.
Secondary Outcomes
- Number and types of complications reported(procedure until 6 month follow up)