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A comparison of a new skin closure device and intradermal sutures in the closure of full-thickness surgical incisions

Dirk Richter, Alexander Stoff, Venkat Ramakrishnan, Klaus Exner, Jan Jernbeck and Phillip Blondeel UGent (2012) PLASTIC AND RECONSTRUCTIVE SURGERY. 130(4). p.843-850
abstract
Background: A novel topical skin adhesive system was developed to close the outermost layer of skin in an expeditious manner. To determine its clinical utility, a clinical investigation was undertaken to demonstrate equivalence of a new adhesive skin closure system (Prineo Skin Closure System) to intradermal sutures in wound closure. Methods: The investigation included 83 patients who underwent elective abdominoplasty, circumferential body lift procedures, and breast reconstruction with deep inferior epigastric perforator flaps. Incisions were divided in half, and each half was randomized to wound closure with the new skin closure system, including a pressure-sensitive adhesive mesh tape for wound edge approximation and next-generation cyanoacrylate or intradermal sutures. Postoperative evaluations took place at 24 hours, 7 days, 12 to 25 days, 90 days, 6 months, and 12 months. Results: The new skin closure system was found to be equivalent to intradermal sutures for the continuous approximation of wounds. The upper limit of the two-sided 90 percent confidence interval for difference in proportions was 10.9 percent. The mean time to closure for the new skin closure system was 1.46 minutes, approximately 5 minutes faster than that for intradermal sutures (p < 0.0001). Both treatments had similar incision healing and cosmetic outcomes. No quantitative or qualitative differences of clinical significance were evident between the treatment groups. Conclusions: The Prineo Skin Closure System can be considered equivalent to intradermal sutures for full-thickness surgical incisions with regard to safety and effectiveness. The ease and speed of application contribute to shortened operative times (4.5 times faster than intradermal sutures).
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
keyword
OCTYL-2-CYANOACRYLATE, 2-OCTYLCYANOACRYLATE, SCAR ASSESSMENT, OCTYLCYANOACRYLATE TISSUE ADHESIVE, HEAD, LACERATIONS
journal title
PLASTIC AND RECONSTRUCTIVE SURGERY
Plast. Reconstr. Surg.
volume
130
issue
4
pages
843 - 850
Web of Science type
Article
Web of Science id
000309544300050
JCR category
SURGERY
JCR impact factor
3.535 (2012)
JCR rank
13/195 (2012)
JCR quartile
1 (2012)
ISSN
0032-1052
DOI
10.1097/PRS.0b013e318262f237
language
English
UGent publication?
yes
classification
A1
copyright statement
I have transferred the copyright for this publication to the publisher
id
3053474
handle
http://hdl.handle.net/1854/LU-3053474
date created
2012-11-14 16:38:39
date last changed
2012-11-19 12:03:30
@article{3053474,
  abstract     = {Background: A novel topical skin adhesive system was developed to close the outermost layer of skin in an expeditious manner. To determine its clinical utility, a clinical investigation was undertaken to demonstrate equivalence of a new adhesive skin closure system (Prineo Skin Closure System) to intradermal sutures in wound closure. 
Methods: The investigation included 83 patients who underwent elective abdominoplasty, circumferential body lift procedures, and breast reconstruction with deep inferior epigastric perforator flaps. Incisions were divided in half, and each half was randomized to wound closure with the new skin closure system, including a pressure-sensitive adhesive mesh tape for wound edge approximation and next-generation cyanoacrylate or intradermal sutures. Postoperative evaluations took place at 24 hours, 7 days, 12 to 25 days, 90 days, 6 months, and 12 months. 
Results: The new skin closure system was found to be equivalent to intradermal sutures for the continuous approximation of wounds. The upper limit of the two-sided 90 percent confidence interval for difference in proportions was 10.9 percent. The mean time to closure for the new skin closure system was 1.46 minutes, approximately 5 minutes faster than that for intradermal sutures (p {\textlangle} 0.0001). Both treatments had similar incision healing and cosmetic outcomes. No quantitative or qualitative differences of clinical significance were evident between the treatment groups. 
Conclusions: The Prineo Skin Closure System can be considered equivalent to intradermal sutures for full-thickness surgical incisions with regard to safety and effectiveness. The ease and speed of application contribute to shortened operative times (4.5 times faster than intradermal sutures).},
  author       = {Richter, Dirk and Stoff, Alexander and Ramakrishnan, Venkat and Exner, Klaus and Jernbeck, Jan and Blondeel, Phillip},
  issn         = {0032-1052},
  journal      = {PLASTIC AND RECONSTRUCTIVE SURGERY},
  keyword      = {OCTYL-2-CYANOACRYLATE,2-OCTYLCYANOACRYLATE,SCAR ASSESSMENT,OCTYLCYANOACRYLATE TISSUE ADHESIVE,HEAD,LACERATIONS},
  language     = {eng},
  number       = {4},
  pages        = {843--850},
  title        = {A comparison of a new skin closure device and intradermal sutures in the closure of full-thickness surgical incisions},
  url          = {http://dx.doi.org/10.1097/PRS.0b013e318262f237},
  volume       = {130},
  year         = {2012},
}

Chicago
Richter, Dirk, Alexander Stoff, Venkat Ramakrishnan, Klaus Exner, Jan Jernbeck, and Phillip Blondeel. 2012. “A Comparison of a New Skin Closure Device and Intradermal Sutures in the Closure of Full-thickness Surgical Incisions.” Plastic and Reconstructive Surgery 130 (4): 843–850.
APA
Richter, D., Stoff, A., Ramakrishnan, V., Exner, K., Jernbeck, J., & Blondeel, P. (2012). A comparison of a new skin closure device and intradermal sutures in the closure of full-thickness surgical incisions. PLASTIC AND RECONSTRUCTIVE SURGERY, 130(4), 843–850.
Vancouver
1.
Richter D, Stoff A, Ramakrishnan V, Exner K, Jernbeck J, Blondeel P. A comparison of a new skin closure device and intradermal sutures in the closure of full-thickness surgical incisions. PLASTIC AND RECONSTRUCTIVE SURGERY. 2012;130(4):843–50.
MLA
Richter, Dirk, Alexander Stoff, Venkat Ramakrishnan, et al. “A Comparison of a New Skin Closure Device and Intradermal Sutures in the Closure of Full-thickness Surgical Incisions.” PLASTIC AND RECONSTRUCTIVE SURGERY 130.4 (2012): 843–850. Print.