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Short Stitch Monomax® (Short-Stitch)

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ClinicalTrials.gov Identifier: NCT01938222
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : February 8, 2019
Sponsor:
Collaborator:
Aesculap AG
Information provided by (Responsible Party):
Diakonie-Klinikum Schwäbisch Hall gGmbH

Tracking Information
First Submitted Date August 26, 2013
First Posted Date September 10, 2013
Last Update Posted Date February 8, 2019
Actual Study Start Date January 2013
Actual Primary Completion Date November 10, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 4, 2013)
Wound-infection rate until day of discharge according to CDC (Centre of Disease Control) Classification [ Time Frame: until discharge (ca. 10 days after operation) ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01938222 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 4, 2013)
  • Reoperation rate due to burst abdomen until discharge [ Time Frame: until discharge (ca. 10 days after operation) ]
  • Wound healing complications until discharge [ Time Frame: until discharge (ca. 10 days after operation) ]
  • Length of postoperative hospital stay [ Time Frame: until discharge (ca. 10 days after operation) ]
  • Use of the suture material (tissue drag, elasticity, knot security, knot pull tensile strength, knot run-down) [ Time Frame: intraoperative ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Short Stitch Monomax®
Official Title A Prospective, Controlled Monocentric Study Evaluating the 6:1 Suture Technique Using Suture Material Monomax® for Abdominal Wall Closure After Primary Abdominal Incision
Brief Summary A number of studies identifies abdominal hernia as the most frequent postoperative complication following laparotomy with percentages of 9-20% - depending on duration of follow-up. It is based on a multifactorial basis, including factors concerning individual, patient-specific factors, factors related to the operational technique as well as particular surgical factors. Wound complications have been reported by 7-12%, burst abdomen rate (dehiscence) < 5 days being 2-4%, wound infection rate (+/- wound dehiscence) ≥ 5 days being 6-10%. In emergency procedures (e.g. ileus, perforation of hollow organ) a wound complication rate of up to 50 % has to be expected. According to new, first findings from recent studies the rates of wound healing complication and burst abdomen can be reduced significantly. Depending on the study, to almost 50%. The principle is based on the reduction of the stitch length and type of the inserted suture. The stitches are closer and with less distance to the edge of fascia. Due to the much thinner suture it still comes here to a quantitative reduction of the inserted suture. The data collected using the MonoMax® suture in the short stitch technique will be compared to the results of the ISSAAC trial, in which the MonoMax® suture was used in the long stitch suture technique. The generated data are thus subject of retrospective comparison with a historical control group (ISSAAC study).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population adult patients
Condition
  • Dehiscence of Laparotomy Wound
  • Surgical Wound Infection
Intervention Procedure: Short Stitch
MonoMax® suture material USP (United States Pharmacopeia) 2/0, 150 cm, HR (half-round) 26 mm needle, will be applied in the short stitch technique (6:1) for abdominal wall closure.
Other Name: MonoMax®
Study Groups/Cohorts Short Stitch
Short stitch suture technique (6:1) for abdominal all closure stitch interval < 0,5 cm and lateral 0,5-0,8 cm
Intervention: Procedure: Short Stitch
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 4, 2013)
351
Original Estimated Enrollment Same as current
Actual Study Completion Date December 7, 2017
Actual Primary Completion Date November 10, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age 18 years and older
  • Primary elective and primary emergency laparotomy
  • Written informed consent

Exclusion Criteria:

- Pregnant women

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01938222
Other Study ID Numbers AAG-I-H-1203
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Diakonie-Klinikum Schwäbisch Hall gGmbH
Study Sponsor Diakonie-Klinikum Schwäbisch Hall gGmbH
Collaborators Aesculap AG
Investigators
Principal Investigator: Markus Golling, Prof. Diakonie-Klinikum Schwäbisch Hall gGmbH
PRS Account Diakonie-Klinikum Schwäbisch Hall gGmbH
Verification Date February 2019