Evaluation of a novel wound closure device

A multicenter randomized controlled trial

Adam J. Singer, Stuart Chale, Phil Giardano, Michael Brian Hocker, Charles Cairns, Richard Hamilton, Milan Nadkarni, Angela M. Mills, Judd E. Hollander

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Objectives: A novel wound closure device combining a mesh tape and octylcyanoacrylate (OCA) topical skin adhesive (TSA) was developed to facilitate wound closure and enhance the adhesive's strength. The objective of this study was to determine whether the incidence of wound dehiscence after laceration repair with the new device was equivalent to that after use of a high-viscosity OCA. We hypothesized that the rate of complete wound edge apposition would be equivalent for the two closure devices. Methods: This was a multicenter, randomized clinical trial in nine academic and community emergency departments (EDs) and urgent care centers. Patients with simple traumatic lacerations were included. Lacerations were randomly closed with a high-viscosity OCA or mesh tape-OCA combination. The rate of complete wound edge apposition at 14 days, rates of wound infection at 14 and 30 days, and the percentage of optimally appearing scars at 30 days after closure were assessed. Assuming a maximal clinically acceptable difference for equivalence of 8% in the rate of completely apposed wound edges, a sample of at least 138 patients in the tape-OCA group and at least 69 in the OCA-only group would give 80% power and a one-sided significance level of 5%. Results: During the study period the investigators enrolled 216 subjects, of whom 143 were randomized to the tape-OCA combination and 73 to the OCA-only group. Most wounds were located on the face and the upper extremities. Mean laceration length was similar in patients in both groups (tape-OCA 2.1 cm vs. OCA-only 2.0 cm; difference 0.1 cm, 95% confidence interval [CI] = -0.45 to 0.58 cm). The rate of complete wound edge apposition at 14 days was higher in wounds treated with the tape-OCA combination than in wounds treated with OCA alone (86.0% vs. 78.1%). The upper bound of the one-sided CI was 1.0% for the intention-to-treat population, which was less than the predetermined acceptable difference of less than 8%. There were no between-group differences in rates of infection and optimally appearing scars. Conclusions: When compared with OCA alone, the novel tape-OCA combination is equivalent with regard to complete wound edge apposition and cosmetic appearance.

Original languageEnglish (US)
Pages (from-to)1060-1064
Number of pages5
JournalAcademic Emergency Medicine
Volume18
Issue number10
DOIs
StatePublished - Oct 1 2011
Externally publishedYes

Fingerprint

Randomized Controlled Trials
Equipment and Supplies
Wounds and Injuries
Lacerations
octylcyanoacrylate
Viscosity
Adhesives
Cicatrix
Confidence Intervals
Emergency Medical Services
Wound Infection
Ambulatory Care Facilities
Upper Extremity
Cosmetics
Hospital Emergency Service
Research Personnel
Skin
Incidence

ASJC Scopus subject areas

  • Emergency Medicine

Cite this

Singer, A. J., Chale, S., Giardano, P., Hocker, M. B., Cairns, C., Hamilton, R., ... Hollander, J. E. (2011). Evaluation of a novel wound closure device: A multicenter randomized controlled trial. Academic Emergency Medicine, 18(10), 1060-1064. https://doi.org/10.1111/j.1553-2712.2011.01177.x

Evaluation of a novel wound closure device : A multicenter randomized controlled trial. / Singer, Adam J.; Chale, Stuart; Giardano, Phil; Hocker, Michael Brian; Cairns, Charles; Hamilton, Richard; Nadkarni, Milan; Mills, Angela M.; Hollander, Judd E.

In: Academic Emergency Medicine, Vol. 18, No. 10, 01.10.2011, p. 1060-1064.

Research output: Contribution to journalArticle

Singer, AJ, Chale, S, Giardano, P, Hocker, MB, Cairns, C, Hamilton, R, Nadkarni, M, Mills, AM & Hollander, JE 2011, 'Evaluation of a novel wound closure device: A multicenter randomized controlled trial', Academic Emergency Medicine, vol. 18, no. 10, pp. 1060-1064. https://doi.org/10.1111/j.1553-2712.2011.01177.x
Singer, Adam J. ; Chale, Stuart ; Giardano, Phil ; Hocker, Michael Brian ; Cairns, Charles ; Hamilton, Richard ; Nadkarni, Milan ; Mills, Angela M. ; Hollander, Judd E. / Evaluation of a novel wound closure device : A multicenter randomized controlled trial. In: Academic Emergency Medicine. 2011 ; Vol. 18, No. 10. pp. 1060-1064.
@article{a33577d6f16a42f3bcbdb954e118c06f,
title = "Evaluation of a novel wound closure device: A multicenter randomized controlled trial",
abstract = "Objectives: A novel wound closure device combining a mesh tape and octylcyanoacrylate (OCA) topical skin adhesive (TSA) was developed to facilitate wound closure and enhance the adhesive's strength. The objective of this study was to determine whether the incidence of wound dehiscence after laceration repair with the new device was equivalent to that after use of a high-viscosity OCA. We hypothesized that the rate of complete wound edge apposition would be equivalent for the two closure devices. Methods: This was a multicenter, randomized clinical trial in nine academic and community emergency departments (EDs) and urgent care centers. Patients with simple traumatic lacerations were included. Lacerations were randomly closed with a high-viscosity OCA or mesh tape-OCA combination. The rate of complete wound edge apposition at 14 days, rates of wound infection at 14 and 30 days, and the percentage of optimally appearing scars at 30 days after closure were assessed. Assuming a maximal clinically acceptable difference for equivalence of 8{\%} in the rate of completely apposed wound edges, a sample of at least 138 patients in the tape-OCA group and at least 69 in the OCA-only group would give 80{\%} power and a one-sided significance level of 5{\%}. Results: During the study period the investigators enrolled 216 subjects, of whom 143 were randomized to the tape-OCA combination and 73 to the OCA-only group. Most wounds were located on the face and the upper extremities. Mean laceration length was similar in patients in both groups (tape-OCA 2.1 cm vs. OCA-only 2.0 cm; difference 0.1 cm, 95{\%} confidence interval [CI] = -0.45 to 0.58 cm). The rate of complete wound edge apposition at 14 days was higher in wounds treated with the tape-OCA combination than in wounds treated with OCA alone (86.0{\%} vs. 78.1{\%}). The upper bound of the one-sided CI was 1.0{\%} for the intention-to-treat population, which was less than the predetermined acceptable difference of less than 8{\%}. There were no between-group differences in rates of infection and optimally appearing scars. Conclusions: When compared with OCA alone, the novel tape-OCA combination is equivalent with regard to complete wound edge apposition and cosmetic appearance.",
author = "Singer, {Adam J.} and Stuart Chale and Phil Giardano and Hocker, {Michael Brian} and Charles Cairns and Richard Hamilton and Milan Nadkarni and Mills, {Angela M.} and Hollander, {Judd E.}",
year = "2011",
month = "10",
day = "1",
doi = "10.1111/j.1553-2712.2011.01177.x",
language = "English (US)",
volume = "18",
pages = "1060--1064",
journal = "Academic Emergency Medicine",
issn = "1069-6563",
publisher = "Wiley-Blackwell",
number = "10",

}

TY - JOUR

T1 - Evaluation of a novel wound closure device

T2 - A multicenter randomized controlled trial

AU - Singer, Adam J.

AU - Chale, Stuart

AU - Giardano, Phil

AU - Hocker, Michael Brian

AU - Cairns, Charles

AU - Hamilton, Richard

AU - Nadkarni, Milan

AU - Mills, Angela M.

AU - Hollander, Judd E.

PY - 2011/10/1

Y1 - 2011/10/1

N2 - Objectives: A novel wound closure device combining a mesh tape and octylcyanoacrylate (OCA) topical skin adhesive (TSA) was developed to facilitate wound closure and enhance the adhesive's strength. The objective of this study was to determine whether the incidence of wound dehiscence after laceration repair with the new device was equivalent to that after use of a high-viscosity OCA. We hypothesized that the rate of complete wound edge apposition would be equivalent for the two closure devices. Methods: This was a multicenter, randomized clinical trial in nine academic and community emergency departments (EDs) and urgent care centers. Patients with simple traumatic lacerations were included. Lacerations were randomly closed with a high-viscosity OCA or mesh tape-OCA combination. The rate of complete wound edge apposition at 14 days, rates of wound infection at 14 and 30 days, and the percentage of optimally appearing scars at 30 days after closure were assessed. Assuming a maximal clinically acceptable difference for equivalence of 8% in the rate of completely apposed wound edges, a sample of at least 138 patients in the tape-OCA group and at least 69 in the OCA-only group would give 80% power and a one-sided significance level of 5%. Results: During the study period the investigators enrolled 216 subjects, of whom 143 were randomized to the tape-OCA combination and 73 to the OCA-only group. Most wounds were located on the face and the upper extremities. Mean laceration length was similar in patients in both groups (tape-OCA 2.1 cm vs. OCA-only 2.0 cm; difference 0.1 cm, 95% confidence interval [CI] = -0.45 to 0.58 cm). The rate of complete wound edge apposition at 14 days was higher in wounds treated with the tape-OCA combination than in wounds treated with OCA alone (86.0% vs. 78.1%). The upper bound of the one-sided CI was 1.0% for the intention-to-treat population, which was less than the predetermined acceptable difference of less than 8%. There were no between-group differences in rates of infection and optimally appearing scars. Conclusions: When compared with OCA alone, the novel tape-OCA combination is equivalent with regard to complete wound edge apposition and cosmetic appearance.

AB - Objectives: A novel wound closure device combining a mesh tape and octylcyanoacrylate (OCA) topical skin adhesive (TSA) was developed to facilitate wound closure and enhance the adhesive's strength. The objective of this study was to determine whether the incidence of wound dehiscence after laceration repair with the new device was equivalent to that after use of a high-viscosity OCA. We hypothesized that the rate of complete wound edge apposition would be equivalent for the two closure devices. Methods: This was a multicenter, randomized clinical trial in nine academic and community emergency departments (EDs) and urgent care centers. Patients with simple traumatic lacerations were included. Lacerations were randomly closed with a high-viscosity OCA or mesh tape-OCA combination. The rate of complete wound edge apposition at 14 days, rates of wound infection at 14 and 30 days, and the percentage of optimally appearing scars at 30 days after closure were assessed. Assuming a maximal clinically acceptable difference for equivalence of 8% in the rate of completely apposed wound edges, a sample of at least 138 patients in the tape-OCA group and at least 69 in the OCA-only group would give 80% power and a one-sided significance level of 5%. Results: During the study period the investigators enrolled 216 subjects, of whom 143 were randomized to the tape-OCA combination and 73 to the OCA-only group. Most wounds were located on the face and the upper extremities. Mean laceration length was similar in patients in both groups (tape-OCA 2.1 cm vs. OCA-only 2.0 cm; difference 0.1 cm, 95% confidence interval [CI] = -0.45 to 0.58 cm). The rate of complete wound edge apposition at 14 days was higher in wounds treated with the tape-OCA combination than in wounds treated with OCA alone (86.0% vs. 78.1%). The upper bound of the one-sided CI was 1.0% for the intention-to-treat population, which was less than the predetermined acceptable difference of less than 8%. There were no between-group differences in rates of infection and optimally appearing scars. Conclusions: When compared with OCA alone, the novel tape-OCA combination is equivalent with regard to complete wound edge apposition and cosmetic appearance.

UR - http://www.scopus.com/inward/record.url?scp=80054691733&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=80054691733&partnerID=8YFLogxK

U2 - 10.1111/j.1553-2712.2011.01177.x

DO - 10.1111/j.1553-2712.2011.01177.x

M3 - Article

VL - 18

SP - 1060

EP - 1064

JO - Academic Emergency Medicine

JF - Academic Emergency Medicine

SN - 1069-6563

IS - 10

ER -