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

Colorectal Surgery Clinical Trial

— REDWIL  

Official title:

Reduction of Wound Infections in Laparoscopic Colon Resections by Wound Protectors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01049971
• Other study ID #: EA4/089/07
• Status: Completed
• Phase: N/A
• First received: January 14, 2010
• Last updated: July 6, 2011
• Start date: December 2007
• Est. completion date: January 2011

Study information

• Verified date: December 2007
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• elective laparoscopic colorectal resection with minilaparotomy

Exclusion Criteria:

• emergency operation

• patients under 18 years of age

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Surgery
• Communicable Diseases
• Infection
• Wound Infection
• Wound Infections

Intervention

Device:
• wound protector
after minilaparotomy, the wound protector is applied
• no wound protector
use of woven drape instead of wound protector

Locations

Country	Name	City	State
Germany	Charité Campus Benjamin Franklin; Hindenburgdamm 30	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of wound infections	the total percentage of wound infections within 6 months postoperatively will be analyzed	6 months postoperatively	No
Secondary	colonialization of abdominal wall with bacteria	a swab of the abdominal wall is taken before skin closure routinely in every participating patient and the bacteria found is analyzed	6 months postoperatively	No
Secondary	postoperative costs	the costs for the operation, for the hospital stay including re-admissions, and for the outpatient stay is analyzed	6 months postoperatively	No
Secondary	length of hospital stay	the total hospital stay including re-admissions is analyzed	6 months postoperatively	No
Secondary	cosmetic result	the satisfaction with the cosmeti result is analyzed in every patient by questionnaire 6 months postoperatively	6 months postoperatively	No