WithdrawnNot Applicable

A Randomized Controlled Trial Comparing Sutures vs Staples for High Tension Closures

Stopped: Administrative withdrawal, study was never approved by IRB

United States0Started 2020-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Scored cosmetic appearance by blinded physician

Timeframe: 2 weeks post procedure

Scored cosmetic appearance by blinded physician

Timeframe: 6 months post procedure

Scored cosmetic appearance by patient

Timeframe: 2 weeks post procedure

Scored cosmetic appearance by patient

Timeframe: 6 months post procedure

Patient self reported comfort with placement of either sutures or staples

Timeframe: at time of surgery

Patient self reported comfort with removal of either sutures or staples

Timeframe: 2 weeks after placement

Trial details

NCT IDNCT06638736

SponsorUniversity of Kansas Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-06

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