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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

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).

Condition or disease Intervention/treatment
Dehiscence of Laparotomy Wound Surgical Wound Infection Procedure: Short Stitch

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Study Type : Observational
Actual Enrollment : 351 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : January 2013
Actual Primary Completion Date : November 10, 2017
Actual Study Completion Date : December 7, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Short Stitch
Short stitch suture technique (6:1) for abdominal all closure stitch interval < 0,5 cm and lateral 0,5-0,8 cm
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®




Primary Outcome Measures :
  1. Wound-infection rate until day of discharge according to CDC (Centre of Disease Control) Classification [ Time Frame: until discharge (ca. 10 days after operation) ]

Secondary Outcome Measures :
  1. Reoperation rate due to burst abdomen until discharge [ Time Frame: until discharge (ca. 10 days after operation) ]
  2. Wound healing complications until discharge [ Time Frame: until discharge (ca. 10 days after operation) ]
  3. Length of postoperative hospital stay [ Time Frame: until discharge (ca. 10 days after operation) ]
  4. Use of the suture material (tissue drag, elasticity, knot security, knot pull tensile strength, knot run-down) [ Time Frame: intraoperative ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
adult patients
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Pregnant women


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938222


Locations
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Germany
Diakonie Klinikum Schwäbisch Hall gGmbH
Schwäbisch Hall, Germany, 74523
Sponsors and Collaborators
Diakonie-Klinikum Schwäbisch Hall gGmbH
Aesculap AG
Investigators
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Principal Investigator: Markus Golling, Prof. Diakonie-Klinikum Schwäbisch Hall gGmbH

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Responsible Party: Diakonie-Klinikum Schwäbisch Hall gGmbH
ClinicalTrials.gov Identifier: NCT01938222     History of Changes
Other Study ID Numbers: AAG-I-H-1203
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019

Keywords provided by Diakonie-Klinikum Schwäbisch Hall gGmbH:
abdominal wall closure
short stitch technique

Additional relevant MeSH terms:
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Wound Infection
Surgical Wound Infection
Surgical Wound
Wounds and Injuries
Infection
Postoperative Complications
Pathologic Processes