Prospective, Randomized, Blinded Study of a New Wound Closure Film Versus Cutaneous Suture for Surgical Wound Closure

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Abstract

BACKGROUND

Wound closure devices include sutures, tissue adhesives, adhesive strips, and staples. Recent studies suggest no differences between various tissue adhesives and sutures for dehiscence, infection, and satisfaction when assessed by patients or surgeons. To date, no studies have investigated ClozeX (Clozex Medical LLC, Wellesley, MA, USA), a novel adhesive strip, for closure of surgical incisions.

OBJECTIVE

To compare surgical wounds repaired with ClozeX versus suture.

METHODS

A prospective, randomized study was conducted, in which 15 patients with surgical incisions were allocated to closure with ClozeX on half of the wound and monofilament suture on the other half. Physician satisfaction with blinded assessment, patient satisfaction, complication rates, and closure times were recorded.

RESULTS

Application with ClozeX was faster than with suture (p=.007). There were no complications in either group. Sixty-nine percent of the patients gave ClozeX a higher satisfaction score (p=.02). More physicians were satisfied with the ClozeX half than with the suture half (p=.007).

CONCLUSIONS

This pilot study demonstrates ClozeX to be a safe and effective closure device. The cosmetic outcome seems to be at least as good as simple running suture. Physicians and patients were generally more satisfied with ClozeX. No difference was found in the rate of dehiscence or infection between the groups.

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