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Completed

NCT Number: NCT01050686

Need for Subcutaneous Wound Drains in Ileostomy Reversal

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.

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Key information

Conditions

Presence of Ileostomy Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité Campus Benjamin Franklin; Hindenburgdamm 30

Berlin, State of Berlin, 12200, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • elective open reversal of an protective ileostomy

Exclusion criteria

  • age < 18 years
  • missing suitability to comprehend patient information

Treatment and study plan

insertion of subcutaneous wound drain

Procedure

after the abdominal fascia is closed and before skin closure, a subcutaneous wound drain is inserted

no insertion of subcutaneous wound drain

Procedure

closure of abdominal wall and skin without insertion of subcutaneous wound drain

Primary outcomes

  1. length of hospital stay (days)

    Time frame: 3 months postoperatively

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Acronym: DRASTAR

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Jan 15, 2010
Registry last updated
Feb 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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