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Need for Subcutaneous Wound Drains in Ileostomy Reversal (DRASTAR)

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ClinicalTrials.gov Identifier: NCT01050686
Recruitment Status : Completed
First Posted : January 15, 2010
Last Update Posted : February 12, 2015
Sponsor:
Information provided by (Responsible Party):
Johannes Lauscher, Charite University, Berlin, Germany

Brief Summary:
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 or disease Intervention/treatment Phase
Presence of Ileostomy Procedure: insertion of subcutaneous wound drain Procedure: no insertion of subcutaneous wound drain Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Need for Subcutaneous Wound Drains in Ileostomy Reversal
Study Start Date : March 2010
Actual Primary Completion Date : November 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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

Secondary Outcome Measures :
  1. surgical site infections [ Time Frame: 3 months postoperatively ]
  2. colonization of abdominal wall with bacteria [ Time Frame: 3 months postoperativly ]
  3. hematomas/ seromas [ Time Frame: 3 months postoperatively ]
  4. postoperative complications [ Time Frame: 3 months postoperatively ]
  5. postoperative pain/ dysaesthesia [ Time Frame: 3 months postoperatively ]
  6. cosmetic result [ Time Frame: 3 months postoperatively ]
  7. postoperative costs [ Time Frame: 3 months postoperatively ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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 Posted: January 15, 2010    Key Record Dates
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