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Need for Subcutaneous Wound Drains in Ileostomy Reversal (DRASTAR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01050686
First Posted: January 15, 2010
Last Update Posted: February 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johannes Lauscher, Charite University, Berlin, Germany
  Purpose
The purpose of this study is to find out whether the insertion of subcutaneous wound drains has an influence on postoperative hospital stay in ileostomy reversal.

Condition Intervention
Presence of Ileostomy Procedure: insertion of subcutaneous wound drain Procedure: no insertion of subcutaneous wound drain

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Need for Subcutaneous Wound Drains in Ileostomy Reversal

Resource links provided by NLM:


Further study details as provided by Johannes Lauscher, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • length of hospital stay (days) [ Time Frame: 3 months postoperatively ]

Secondary Outcome Measures:
  • surgical site infections [ Time Frame: 3 months postoperatively ]
  • colonization of abdominal wall with bacteria [ Time Frame: 3 months postoperativly ]
  • hematomas/ seromas [ Time Frame: 3 months postoperatively ]
  • postoperative complications [ Time Frame: 3 months postoperatively ]
  • postoperative pain/ dysaesthesia [ Time Frame: 3 months postoperatively ]
  • cosmetic result [ Time Frame: 3 months postoperatively ]
  • postoperative costs [ Time Frame: 3 months postoperatively ]

Enrollment: 102
Study Start Date: March 2010
Study Completion Date: February 2015
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: subcutaneous wound drain
subcutaneous wound drain inserted
Procedure: insertion of subcutaneous wound drain
after the abdominal fascia is closed and before skin closure, a subcutaneous wound drain is inserted
Experimental: no subcutaneous wound drain
no subcutaneous wound drain inserted
Procedure: no insertion of subcutaneous wound drain
closure of abdominal wall and skin without insertion of subcutaneous wound drain

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective open reversal of an protective ileostomy

Exclusion Criteria:

  • age < 18 years
  • missing suitability to comprehend patient information
  Contacts and Locations
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): NCT01050686


Locations
Germany
Charité Campus Benjamin Franklin; Hindenburgdamm 30
Berlin, Germany, 12200
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Johannes C Lauscher, MD Charite University, Berlin, Germany
  More Information

Responsible Party: Johannes Lauscher, PD Dr. Johannes Lauscher, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01050686     History of Changes
Other Study ID Numbers: EA4/120/09
First Submitted: January 14, 2010
First Posted: January 15, 2010
Last Update Posted: February 12, 2015
Last Verified: February 2015

Keywords provided by Johannes Lauscher, Charite University, Berlin, Germany:
ileostomy reversal
subcutaneous drain
hospital stay
postoperative wound infection
patients with elective ileostomy reversal