Need for Subcutaneous Wound Drains in Ileostomy Reversal (DRASTAR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johannes Lauscher, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01050686
First received: January 14, 2010
Last updated: February 11, 2015
Last verified: February 2015
  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: 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 Charite University, Berlin, Germany:

Primary Outcome Measures:
  • length of hospital stay (days) [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • surgical site infections [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
  • colonization of abdominal wall with bacteria [ Time Frame: 3 months postoperativly ] [ Designated as safety issue: No ]
  • hematomas/ seromas [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
  • postoperative complications [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
  • postoperative pain/ dysaesthesia [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
  • cosmetic result [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]
  • postoperative costs [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Charité Campus Benjamin Franklin
  More Information

No publications provided

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
Study First Received: January 14, 2010
Last Updated: February 11, 2015
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on August 27, 2015