NCT01049971

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 15, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

July 7, 2011

Status Verified

December 1, 2007

Enrollment Period

3.1 years

First QC Date

January 14, 2010

Last Update Submit

July 6, 2011

Conditions

Colorectal SurgeryWound Infections

Keywords

colorectal surgerywound infectionwound protectorlaparoscopysurgical site infection after laparoscopic colorectal surgery with minilaparotomy

Outcome Measures

Primary Outcomes (1)

  • percentage of wound infections

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

    6 months postoperatively

Secondary Outcomes (4)

  • colonialization of abdominal wall with bacteria

    6 months postoperatively

  • postoperative costs

    6 months postoperatively

  • length of hospital stay

    6 months postoperatively

  • cosmetic result

    6 months postoperatively

Study Arms (2)

no wound protector

ACTIVE COMPARATOR

instead of wound protector, a woven drape is applied

Device: no wound protector

wound protector

EXPERIMENTAL

after minilaparotomy, wound protector is applied

Device: wound protector

Interventions

wound protectorDEVICE

after minilaparotomy, the wound protector is applied

Also known as: Vi-Drape (Trademark) wound protector
wound protector
no wound protectorDEVICE

use of woven drape instead of wound protector

no wound protector

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective laparoscopic colorectal resection with minilaparotomy

You may not qualify if:

  • emergency operation
  • patients under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Campus Benjamin Franklin; Hindenburgdamm 30

Berlin, State of Berlin, 12200, Germany

Location

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 14, 2010

First Posted

January 15, 2010

Study Start

December 1, 2007

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

July 7, 2011

Record last verified: 2007-12

Locations

DE(1)