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Intracutaneous suture versus transcutaneous skin stapling for closure of midline or horizontal skin incision in elective abdominal surgery and their outcome on superficial surgical site infections–INTRANS: study protocol for a randomized controlled trial

BACKGROUND: Surgical site infections are the third most frequent type of nosocomial infections. Evidence-based recommendations have been given regarding preoperative hospitalization, hygiene and air-conditioning, patient conditions, and wound dressing. However, no general recommendations concerning...

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Autores principales: Maschuw, Katja, Heinz, Christine, Maurer, Elisabeth, Reuss, Alexander, Schade-Brittinger, Carmen, Bartsch, Detlef Klaus
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3899381/
https://www.ncbi.nlm.nih.gov/pubmed/24433264
http://dx.doi.org/10.1186/1745-6215-15-25
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author Maschuw, Katja
Heinz, Christine
Maurer, Elisabeth
Reuss, Alexander
Schade-Brittinger, Carmen
Bartsch, Detlef Klaus
author_facet Maschuw, Katja
Heinz, Christine
Maurer, Elisabeth
Reuss, Alexander
Schade-Brittinger, Carmen
Bartsch, Detlef Klaus
author_sort Maschuw, Katja
collection PubMed
description BACKGROUND: Surgical site infections are the third most frequent type of nosocomial infections. Evidence-based recommendations have been given regarding preoperative hospitalization, hygiene and air-conditioning, patient conditions, and wound dressing. However, no general recommendations concerning wound closure exist. Systematic reviews and meta-analyses suppose a benefit of intracutaneous suture compared to skin staples in orthopedic and obstetric surgery. Literature data for skin closure in elective abdominal surgery are still deficient. METHODS/DESIGN: Patients scheduled for any elective abdominal surgery requiring midline or horizontal laparotomy are potentially eligible for the trial. Trial-specific exclusion criteria are date of admission exceeding four days prior to surgery, antibiotic treatment within the past 14 days, any previous midline or horizontal laparotomy in case the procedure requires the same skin incision as before, neurophysiological deficits or severe psychiatric or neurologic diseases that do not allow an informed consent or compliance, and participation in any other interventional trial with interference of intervention and outcome. The trial is created for process innovation within standardized surgical procedures. It is designed as a prospective randomized controlled single center trial in a parallel design including an active comparator and an intervention group. The intervention addresses the closure of skin after the main surgical procedure: intracutaneous suture in the intervention group and transcutaneous skin stapling in the control group. The rate of superficial surgical site infections is defined as the primary endpoint. Secondary endpoints are time for skin closure, satisfaction with the cosmetic outcome 30 days after surgery, prolongation of hospital stay, and duration of sick-leave due to surgical site infections. The primary efficacy analysis follows the intention-to-treat principle. A χ(2) test will be applied. DISCUSSION: The trial is expected to balance the shortcomings of the current evidence. It will help to define the gold standard for wound closure in elective abdominal surgery. Patients’ safety and quality of life are assumed to be enhanced. Therapy costs are likely to be reduced and health care optimized. TRIAL REGISTRATION: German Clinical Trials Register (DRKS) DRKS00004542.
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spelling pubmed-38993812014-01-24 Intracutaneous suture versus transcutaneous skin stapling for closure of midline or horizontal skin incision in elective abdominal surgery and their outcome on superficial surgical site infections–INTRANS: study protocol for a randomized controlled trial Maschuw, Katja Heinz, Christine Maurer, Elisabeth Reuss, Alexander Schade-Brittinger, Carmen Bartsch, Detlef Klaus Trials Study Protocol BACKGROUND: Surgical site infections are the third most frequent type of nosocomial infections. Evidence-based recommendations have been given regarding preoperative hospitalization, hygiene and air-conditioning, patient conditions, and wound dressing. However, no general recommendations concerning wound closure exist. Systematic reviews and meta-analyses suppose a benefit of intracutaneous suture compared to skin staples in orthopedic and obstetric surgery. Literature data for skin closure in elective abdominal surgery are still deficient. METHODS/DESIGN: Patients scheduled for any elective abdominal surgery requiring midline or horizontal laparotomy are potentially eligible for the trial. Trial-specific exclusion criteria are date of admission exceeding four days prior to surgery, antibiotic treatment within the past 14 days, any previous midline or horizontal laparotomy in case the procedure requires the same skin incision as before, neurophysiological deficits or severe psychiatric or neurologic diseases that do not allow an informed consent or compliance, and participation in any other interventional trial with interference of intervention and outcome. The trial is created for process innovation within standardized surgical procedures. It is designed as a prospective randomized controlled single center trial in a parallel design including an active comparator and an intervention group. The intervention addresses the closure of skin after the main surgical procedure: intracutaneous suture in the intervention group and transcutaneous skin stapling in the control group. The rate of superficial surgical site infections is defined as the primary endpoint. Secondary endpoints are time for skin closure, satisfaction with the cosmetic outcome 30 days after surgery, prolongation of hospital stay, and duration of sick-leave due to surgical site infections. The primary efficacy analysis follows the intention-to-treat principle. A χ(2) test will be applied. DISCUSSION: The trial is expected to balance the shortcomings of the current evidence. It will help to define the gold standard for wound closure in elective abdominal surgery. Patients’ safety and quality of life are assumed to be enhanced. Therapy costs are likely to be reduced and health care optimized. TRIAL REGISTRATION: German Clinical Trials Register (DRKS) DRKS00004542. BioMed Central 2014-01-16 /pmc/articles/PMC3899381/ /pubmed/24433264 http://dx.doi.org/10.1186/1745-6215-15-25 Text en Copyright © 2014 Maschuw et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Maschuw, Katja
Heinz, Christine
Maurer, Elisabeth
Reuss, Alexander
Schade-Brittinger, Carmen
Bartsch, Detlef Klaus
Intracutaneous suture versus transcutaneous skin stapling for closure of midline or horizontal skin incision in elective abdominal surgery and their outcome on superficial surgical site infections–INTRANS: study protocol for a randomized controlled trial
title Intracutaneous suture versus transcutaneous skin stapling for closure of midline or horizontal skin incision in elective abdominal surgery and their outcome on superficial surgical site infections–INTRANS: study protocol for a randomized controlled trial
title_full Intracutaneous suture versus transcutaneous skin stapling for closure of midline or horizontal skin incision in elective abdominal surgery and their outcome on superficial surgical site infections–INTRANS: study protocol for a randomized controlled trial
title_fullStr Intracutaneous suture versus transcutaneous skin stapling for closure of midline or horizontal skin incision in elective abdominal surgery and their outcome on superficial surgical site infections–INTRANS: study protocol for a randomized controlled trial
title_full_unstemmed Intracutaneous suture versus transcutaneous skin stapling for closure of midline or horizontal skin incision in elective abdominal surgery and their outcome on superficial surgical site infections–INTRANS: study protocol for a randomized controlled trial
title_short Intracutaneous suture versus transcutaneous skin stapling for closure of midline or horizontal skin incision in elective abdominal surgery and their outcome on superficial surgical site infections–INTRANS: study protocol for a randomized controlled trial
title_sort intracutaneous suture versus transcutaneous skin stapling for closure of midline or horizontal skin incision in elective abdominal surgery and their outcome on superficial surgical site infections–intrans: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3899381/
https://www.ncbi.nlm.nih.gov/pubmed/24433264
http://dx.doi.org/10.1186/1745-6215-15-25
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