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AppendicitisPhase 4ASCNCT02625987

Appendicectomy Skin Closure Technique: Changing Paradigms (ASC)

A Phase 4 study testing Continuous intradermic stitch and Separated stitches in people with Appendicitis, run by María Valeria Jiménez Baez.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To compare the results associated with two different skin closure techniques in open appendectomy. 200 patients were included after acute appendicitis diagnosis in emergency department. Read more about this study

Who is it for?
Ages 1 year to 60 years
Conditions the study is for
Appendicitis
What is being tested?
Continuous intradermic stitch and Separated stitches
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
No sites listed yet
Study dates
Apr 2015to Sep 2015
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 1 year to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Both gender
  • Appendicitis diagnosis
  • Informed consent signed
  • 0-60 age year old
  • surgical confirmation of acute appendicitis
  • Antibiotic prophylaxis

Who cannot join

  • Appendicitis diagnosis in patients >60 years old
  • No antibiotic prophylaxis
  • No informed consent signed

About this study

Official title: Comparison Between Intradermic vs Habitual Skin Closure Technique in Open Appendicectomy.

To compare the results associated with two different skin closure techniques in open appendectomy. 200 patients were included after acute appendicitis diagnosis in emergency department. They were grouped randomly into two groups: patients who would receive skin closure with skin closure by an unique absorbable intradermic stitch (Group A) and another that would receive a habitual technique consistent in non absorbable separated stitches (Group B). General characteristics like gender, age, body mass index (IMC), comorbidities and allergies were registered. Days of evolution (DOE) until surgery, use of antibiotics previously, complicated or uncomplicated appendicitis, surgery time and wound complications like skin infection, dehiscence, seroma or abscess were registered in each case too,

Read the detailed description

Registration number R2015-2301-6 by Local Committee on Ethics in Health Research and Social Security Mexican Institute, Zone 03 General Hospital. The investigators conduct the study at the Hospital General Regional No. 17 in Cancun, Quintana Roo. México. At time in which General Surgery Department determined acute appendicitis diagnosis and prophylaxis antibiotics administered with 3rd generation cephalosporin and Metronidazole, patients receive information about the study and treatment options and informed consent were signed. After this, patients were randomly assigned to one of two study groups. Group A receives a skin closure with a unique absorbable suture intradermal stitch. Group B receives a skin closure with habitual technique, consistent in separated stitch of a non-absorbable suture. The surgical and skin closure techniques were standardized among eight surgeons who participate in the study.

Acute appendicitis diagnosis was established by clinical history, physical exam and laboratory test including blood count, glucose, urea, creatinine, general urinary exam and clothing times. An Alvarado scale >7 points or the surgeon opinion was diagnostic of appendicitis. General information about the patients were recorded like gender, age, body mass index (IMC), comorbidities and allergies were registered. Clinical history information like DOE and previous antibiotics use were registered too.

After explanation of the diagnosis and treatment options, the patients were informed about this study, the objectives, implications, possible outcomes and complications. The patients or legal tutor of the patients refer to understand the possible risk and consequences and if they accept to be included in the study an informed consent was signed.

One hour before skin incision a prophylaxis dose of a 3rd Generation Cephalosporin (Cefotaxime) and Metronidazole were administered. According to a randomized list patients were assigned to one of the two study groups previous to his/her skin incision. The surgical and skin closure technique were standardized and verified by the protocol author previous to the development of any appendectomy by the eight surgeons included in the study.

A Rochy-Davis incision was performed in all cases and aspiration of purulent liquid when required. Stump management with Halsted or Pouchet technique was done. Abdominal cavity was cleaned only with gauze pads, no drain were placed. After aponeurosis closure with Polyglactina 910 #1 continuous point, wound lavage with NaCl 0.9% solution was performed. Dermis was closed with Polyglactina 910 #3-0. In Group A Polyglactina 910 # 3-0 intradermic continuous point was done. In Group B skin closure with Nylon #3-0 separated stitches was achieved.

Liquid diet was ingested 8 hours after surgery and progressed to normal if tolerated. In cases of complicated appendicitis antibiotics were continued four to five days and for uncomplicated appendicitis only by 2 days or until inflammatory systemic response signs were absent. When diet was tolerated and systemic response signs were absent discharge was accomplished.

Surgery incision was evaluated daily until discharge and in extern consult at 7 and 30 days after surgery. In case of group B stitches removal were done at 10 days after surgery.

Days of evolution (DOE) previous to appendicitis diagnose, use of antibiotics previously, complicated or uncomplicated appendicitis, surgery time and wound complications like skin infection, dehiscence, seroma or abscess were registered in each case.

Database was performed and the statistical program SPSS version 22.0 for Mac IOS 7.0 was used to perform statistical data analysis. Complications, surgical and general characteristics were registered and compared between the groups using X2 test. A multivariate analysis was performed for independent variables and the possible association with complications.

Conditions
Appendicitis
Being tested
Continuous intradermic stitch, Separated stitches
Keywords
Appendicectomy, wound complications, skin closure
Medical subject headings
Appendicitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous intradermic stitchProcedure or surgery

    Also called Subdermic closure with an absorbable suture

    Appendectomy wound closure with an intradermic Polyglactina 910 stitch

  • Separated stitchesProcedure or surgery

    Also called Habitual appendectomy wound closure

    Appendectomy wound closure with a separated stitches.

Study groups in NCT02625987
Study groupRoleWhat they receive
Continuous intradermic stitchExperimentalClosure was did with a continuous intradermic stitch.
Receives: Procedure: Continuous intradermic stitch
Separated stitchesSham comparatorLike comparator was used a closure with separated stitches.
Receives: Procedure: Separated stitches

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Decrease in wound complications after appendectomy

    Complication like wound seroma, infection, dehiscence or abscess would be registered in each one of the two groups and the incidence compared between them to stablish which one is the best option.

    Measured: 1-30 days after surgery

Secondary outcomes (1)
  1. Factors associated with appendectomy complications developement

    General data and surgery data will be analyzed

    Measured: Previous to surgery and during surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionAug 2015
  4. Study completionSep 2015

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02625987
Sponsor's protocol ID
2015-2301-6
Acronym
ASC
Status last verified
May 2016
First submitted
7 Dec 2015
Last updated
27 May 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Andrade LA, Munoz FY, Baez MV, Collazos SS, de Los Angeles Martinez Ferretiz M, Ruiz B, Montes O, Woolf S, Noriega JG, Aparicio UM, Gonzalez IG. Appendectomy Skin Closure Technique, Randomized Controlled Trial: Changing Paradigms (ASC). World J Surg. 2016 Nov;40(11):2603-2610. doi: 10.1007/s00268-016-3607-x.

    PubMed 27283187

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Continuous intradermic stitch and Separated stitches in people with Appendicitis, run by María Valeria Jiménez Baez.

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 6 inclusion and 3 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 27 May 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Decrease in wound complications after appendectomy (time frame: 1-30 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02625987, which also lists 1 linked publication.

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 27 May 2016.

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ASC Clinical Trial NCT02625987 | AzTrials