Wound Healing After Emergency Appendicectomy

This study has been completed.

Sponsor:

Information provided by:

Tampere University Hospital

ClinicalTrials.gov Identifier:

NCT00913445

First received: June 2, 2009

Last updated: June 10, 2010

Last verified: May 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	June 2, 2009
Last Updated Date	June 10, 2010
Start Date ^ICMJE	July 2009
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 20, 2009)	Wound heeling [ Time Frame: 14 days after operation ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: June 3, 2009)	Wound heeling [ Time Frame: 14 and 30 days after operation ] [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT00913445 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 3, 2009)	Cosmetic result [ Time Frame: 1 year after operation ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Wound Healing After Emergency Appendicectomy
Official Title ^ICMJE	Wound Healing and Cosmetic Result After Emergency Appendicectomy in Adult Patients: a Prospective, Randomised Trial Comparing Two Methods of Wound Closure
Brief Summary	The purpose of this trial is to compare two techniques of wound closure in open appendicectomies in adult patients: continuous, absorbable, intradermal suture and interrupted, non-absorbable sutures.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Appendicitis
Intervention ^ICMJE	Procedure: appendicectomy Wound healing after absorbable and nonabsorbable stitches are compared
Study Arm (s)	Active Comparator: surgery, absorbable stitches wound healing after absorbable and nonabsorbable stitches are compared Intervention: Procedure: appendicectomy Active Comparator: surgery, nonabsorbable stitches Intervention: Procedure: appendicectomy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	200
Completion Date	May 2010
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Adult patient with acute appendicitis Exclusion Criteria: Children
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Finland

Administrative Information
NCT Number ^ICMJE	NCT00913445
Other Study ID Numbers ^ICMJE	R09060
Has Data Monitoring Committee	No
Responsible Party	Tuomo Rantanen MD,PhD, Tampere University Hospital
Study Sponsor ^ICMJE	Tampere University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Tampere University Hospital
Verification Date	May 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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