AppendicitisPhase 4NCT00913445
Wound Healing After Emergency Appendicectomy
A Phase 4 study testing appendicectomy in people with Appendicitis, run by Tampere University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appendicitis
- What is being tested?
- appendicectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFinland
- Study dates
- Jul 2009to May 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient with acute appendicitis
Who cannot join
- Children
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wound Healing and Cosmetic Result After Emergency Appendicectomy in Adult Patients: a Prospective, Randomised Trial Comparing Two Methods of Wound Closure
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.
- Conditions
- Appendicitis
- Being tested
- appendicectomy
- Keywords
- Appendicitis, appendicectomy, stitches, wound healing, cosmetic results
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
appendicectomyProcedure or surgery
Wound healing after absorbable and nonabsorbable stitches are compared
| Study group | Role | What they receive |
|---|---|---|
| surgery, absorbable stitches | Active comparator | wound healing after absorbable and nonabsorbable stitches are compared Receives: Procedure: appendicectomy |
| surgery, nonabsorbable stitches | Active comparator | Not described Receives: Procedure: appendicectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound heeling
Measured: 14 days after operation
Secondary outcomes (1)
Cosmetic result
Measured: 1 year after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00913445
- Sponsor's protocol ID
- R09060
- Status last verified
- May 2010
- First submitted
- 2 Jun 2009
- Last updated
- 11 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound Healing and Cosmetic Result After Emergency Appendicectomy in Adult Patients: a Prospective, Randomised Trial Comparing Two Methods of Wound Closure
- ClinicalTrials.gov ID
- NCT00913445
- Acronym / sponsor ID
- R09060
- Conditions
- Appendicitis
- Keywords
- Appendicitis, appendicectomy, stitches, wound healing, cosmetic results
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 4 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery, absorbable stitches | Active comparator | Procedure: appendicectomywound healing after absorbable and nonabsorbable stitches are compared |
| surgery, nonabsorbable stitches | Active comparator | Procedure: appendicectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patient with acute appendicitis
Key exclusion criteria (1 listed)
- Children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| appendicectomyWound healing after absorbable and nonabsorbable stitches are compared | Procedure or surgery | surgery, absorbable stitches, surgery, nonabsorbable stitches |
Primary outcome
Wound heeling
Time frame: 14 days after operation
1 secondary outcome
Cosmetic result
Time frame: 1 year after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing appendicectomy in people with Appendicitis, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound heeling (time frame: 14 days after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2010.