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Completed

NCT Number: NCT01049971

REDWIL: Reduction of Wound Infections in Laparoscopic Colon Resections by Wound Protectors

Surgical site infection is common in colorectal surgery leading to increased postoperative pain, longer hospital stay, delayed wound healing and increased re-operation rates. Hence, reducing the wound infection rate is a major aim in abdominal surgery.

Wound protectors were invented for retracting the abdominal wall and keeping the abdominal wall sterile in order to reduce bacterial colonialization of the wound and wound infections.

This is a prospective-randomized trial comparing use of wound protectors versus woven drapes in laparoscopic colon resections with minilaparotomy.

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Key information

Conditions

Colorectal Surgery Infections Wound Infection Wound Infections

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 laparoscopic colorectal resection with minilaparotomy

Exclusion criteria

  • emergency operation
  • patients under 18 years of age

Treatment and study plan

wound protector

Device

after minilaparotomy, the wound protector is applied

Other names: Vi-Drape (Trademark) wound protector

no wound protector

Device

use of woven drape instead of wound protector

Primary outcomes

  1. percentage of wound infections

    Time frame: 6 months postoperatively

    the total percentage of wound infections within 6 months postoperatively will be analyzed

Secondary outcomes

  1. colonialization of abdominal wall with bacteria

    Time frame: 6 months postoperatively

    a swab of the abdominal wall is taken before skin closure routinely in every participating patient and the bacteria found is analyzed

  2. postoperative costs

    Time frame: 6 months postoperatively

    the costs for the operation, for the hospital stay including re-admissions, and for the outpatient stay is analyzed

  3. length of hospital stay

    Time frame: 6 months postoperatively

    the total hospital stay including re-admissions is analyzed

  4. cosmetic result

    Time frame: 6 months postoperatively

    the satisfaction with the cosmeti result is analyzed in every patient by questionnaire 6 months postoperatively

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Reduction of Wound Infections in Laparoscopic Colon Resections by Wound Protectors

Acronym: REDWIL

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jan 15, 2010
Registry last updated
Jul 7, 2011

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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