NCT00913445

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_4

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2009

Completed
27 days until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

June 11, 2010

Status Verified

May 1, 2010

Enrollment Period

10 months

First QC Date

June 2, 2009

Last Update Submit

June 10, 2010

Conditions

Appendicitis

Keywords

Appendicitisappendicectomystitcheswound healingcosmetic results

Outcome Measures

Primary Outcomes (1)

  • Wound heeling

    14 days after operation

Secondary Outcomes (1)

  • Cosmetic result

    1 year after operation

Study Arms (2)

surgery, absorbable stitches

ACTIVE COMPARATOR

wound healing after absorbable and nonabsorbable stitches are compared

Procedure: appendicectomy

surgery, nonabsorbable stitches

ACTIVE COMPARATOR
Procedure: appendicectomy

Interventions

appendicectomyPROCEDURE

Wound healing after absorbable and nonabsorbable stitches are compared

surgery, absorbable stitchessurgery, nonabsorbable stitches

Eligibility Criteria

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

You may qualify if:

  • Adult patient with acute appendicitis

You may not qualify if:

  • Children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, Pirkanmaa, Finland

Location

MeSH Terms

Conditions

Appendicitis

Interventions

Appendectomy

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 2, 2009

First Posted

June 4, 2009

Study Start

July 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

June 11, 2010

Record last verified: 2010-05

Locations

FI(1)