Author(s): Lance L. Swick, Debbie Mencke, Michael J. Suah
Purpose: A small clinical study was performed to assess the use of a novel poly (urea-urethane) liquid bandage (Nuvaderm, Chesson Labs, Durham, NC) as a post-surgical wound care treatment in patients that underwent skin cancer excision surgery. Nuvaderm is a topical medical device that has been cleared by the United States Food and Drug Administration (FDA). Nuvaderm was evaluated for wound healing, moisture vapor permeability, microbial barrier effectiveness, and ease of use.
Methods: A prospective, single-arm clinical evaluation was performed with adult subjects with skin cancer on the head or body. Excision surgery was performed to remove the cancer and the lesion was subsequently closed with sutures. Nuvaderm was applied to the surgical site and a pressure dressing was applied on top to control any bleeding. After 24 h, patients removed the pressure dressing and self-treated with Nuvaderm liquid bandage daily for approximately 7-14 days. Clinical assessments were performed at roughly 7 or 14 days after surgery for head and body wounds, respectively. The primary effectiveness endpoints were to assess wound healing and infection rate after daily treatment with Nuvaderm. The primary safety endpoint was free from product-related adverse events for the duration of treatment term. In vitro testing was performed for antimicrobial and microbial barrier properties and moisture vapor permeability. These tests were carried out using ASTM E2315 (Standard Guide for Assessment of Antimicrobial Activity Using a Time-Kill Procedure), ASTM F1608 (Standard Test Method for Microbial Ranking of Porous Packaging Materials), and ASTM E96 (Standard Test Methods for Water Vapor Transmission of Materials), respectively.
Results: Initial in vitro studies demonstrated that Nuvaderm is a biocompatible, durable liquid bandage that functions as a microbial barrier with antimicrobial properties and water vapor permeability. 43 patients (61% males), aged 44 to 85 yrs, with skin cancer on the head or body underwent excision surgery to remove the growth or lesion. All patients applied Nuvaderm daily with no infection or serious adverse events. 17 (39%) patients reported a mild stinging sensation at least once when Nuvaderm was applied to the wound site. Of the 42 respondents, 95% were satisfied with how Nuvaderm aftercare treatment relieved symptoms of their surgery. One patient reported erythema around the wound and two reported the wound felt dry and itchy.
Conclusion: This study describes a topical medical device with antimicrobial properties that protects wounds from infection and complements wound healing in patients after skin cancer excision surgery. Nuvaderm liquid bandage compares favorably with current standards of care for post-surgical wound treatments and provides an easy to use wound care system for patients.