Surgical Site InfectionPhase 3NCT01659983
Efficacy Study of Delayed Primary Closure to Reduce Rate of Wound Infection in Complicated Appendicitis
A Phase 3 study testing Primary wound closure in people with Surgical Site Infection, run by Ramathibodi Hospital at 7 sites in Thailand.
Trial summary
Research hypothesis: Does delayed primary wound closure after appendectomy in adults with complicated appendicitis reduce postoperative superficial surgical site infection compare to primary wound closure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Primary wound closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 7 sitesThailand
- Study dates
- Nov 2012to Mar 2016
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients age 18 years or older
- Have been diagnosed as gangrenous or ruptured appendicitis base on clinical criteria with the following conditions
- a.Gangrenous appendicitis i.Erythematous or swelling of appendix and ii.Appearance of necrotic wall (dark, grayish color) b.Ruptured appendicitis i. Erythematous or swelling of appendix and ii.Appearance of hole in an appendix or iii.Rupture of appendix during a procedure c.Appearance of frank pus
- Non-immunocompromised hosts which include
- AIDS
- History of end-stage renal disease (ESRD)
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- History of autoimmune disease (SLE)
- Taking immunosuppressive agents (e.g, steroids, Cyclophosphamide, Tacrolimus, Mycophenolate mofetil)
- Cirrhosis with ascites
- Morbid obesity (BMI > 40 kg/m2)
- Non-pregnant women
- Willing to participate and provide written informed consent
Who cannot join
None listed.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Thailand7 sites
Vachira hospital
Dusit, Bangkok, 10300
Chonburi hospital
Meaung, Changwat Chon Buri, 20000
Surin hospital
Meung, Changwat Surin
Pathumtani hospital
Meung, Pathumtani, 12110
Lampang hospital
Meung
Department of Surgery, Ramathibodi Hospital
Rachatevi, Bangkok, 10400
Thammasat hospital
Rangsit City Municipality, Patumtani, 12120
About this study
Official title: Comparison of Surgical Site Infection Between Delayed Primary Closure Versus Primary Closure in Complicated Appendicitis: A Multicenter Randomized Controlled Trial
Research hypothesis:
Does delayed primary wound closure after appendectomy in adults with complicated appendicitis reduce postoperative superficial surgical site infection compare to primary wound closure.
Study design:
This study is a multicenter randomized controlled trial of delay versus primary wound closure in complicated appendicitis.
Setting:
Thammasat Hospital, Ramathibodi Hospital, Chonburi Hospital, Chonpratarn Hospital, Vachira Hospital, and Pathumthani Hospital
Participants:
Adult patients age 18 years or older and non-pregnant in women who have been diagnosed as gangrenous or ruptured appendicitis.
Outcome:
Superficial surgical site infection
Period of study:
August 2012 - August 2014
- Conditions
- Surgical Site Infection
- Being tested
- Primary wound closure
- Keywords
- complicated appendicitis, wound closure, infection
- Medical subject headings
- Surgical Wound Infection, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary wound closureProcedure or surgery
A wound will be sutured immediately after the operative procedure uisng non-absorbable monofilament suture or stapler at intervals of one centimeter apart and 0.5 cm back from a wound edge.
| Study group | Role | What they receive |
|---|---|---|
| Primary wound closure | Experimental | A wound will be sutured immediately after the operative procedure uisng non-absorbable monofilament suture or stapler at intervals of one centimeter apart and 0.5 cm back from a wound edge. Receives: Procedure: Primary wound closure |
| Delayed primary wound closure | Active comparator | A wound will be left open with saline-soaked gauze packing after the operative procedure and will be sutured around day 3 to 7 after operation Receives: Procedure: Primary wound closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superficial surgical site infection (SSI)
Superficial SSI, which will be diagnosed using the Center for Disease Control (CDC) criteria as follows:
- Infection within 30 days and
- Involves only skin and subcutaneous tissue of the incision and
- One of the following:
- Purulent drainage,
- organism isolated from culture of fluid or tissue
- one of the following signs or symptoms:
- pain or tenderness;
- localized, swelling, redness, or
- heat And the superficial incision is deliberately opened by surgeon
Measured: within 1 month after operation
Secondary outcomes (3)
postoperative pain
- Postoperative pain will be assessed using visual analog scale (VAS, ranged from 0-10) at day 1 and 3
Measured: within 3 days after operation
Quality of life
Quality of life will be assessed using the Thai EQ5D questionnaires before an operation, days 3 and 1 month after operation
Measured: 1 month after operation
Cost of treatment
Both direct and indirect costs of treatment will be recorded
Measured: 1 month after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startNov 2012
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Thammasat University Hospital, Chonburi hospital, Vachira hospital, Pathumtani Hospital, Lampang Hospital, Surin Hospital
- Responsible party
- Principal investigator, Boonying Siribumrungwong, Ramathibodi Hospital
- Investigators
- Boonying Siribumrungwong, MD, Principal investigator, Ramathibodi HospitalAmmarin Thakkinstian, PhD, Study chair, Ramathibodi HospitalPatarawan Woratanarat, Study chair, Ramathibodi HospitalBorwornsom Leerapan, Study chair, Ramathibodi HospitalJittunut Hawanon, Study chair, Thammasat University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659983
- Sponsor's protocol ID
- ID 04-55-18 ว
- Status last verified
- Apr 2016
- First submitted
- 25 Jun 2012
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Noorit P, Siribumrungwong B, Thakkinstian A. Clinical prediction score for superficial surgical site infection after appendectomy in adults with complicated appendicitis. World J Emerg Surg. 2018 Jun 18;13:23. doi: 10.1186/s13017-018-0186-1. eCollection 2018.
PubMed 29946346
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Surgical Site Infection Between Delayed Primary Closure Versus Primary Closure in Complicated Appendicitis: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01659983
- Acronym / sponsor ID
- ID 04-55-18 ว
- Conditions
- Surgical Site Infection
- Keywords
- complicated appendicitis, wound closure, infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Collaborators
- Thammasat University Hospital, Chonburi hospital, Vachira hospital, Pathumtani Hospital, Lampang Hospital, Surin Hospital
- Study start
- Nov 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 8 Aug 2012 (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.
Research hypothesis:
Does delayed primary wound closure after appendectomy in adults with complicated appendicitis reduce postoperative superficial surgical site infection compare to primary wound closure.
Study design:
This study is a multicenter randomized controlled trial of delay versus primary wound closure in complicated appendicitis.
Setting:
Thammasat Hospital, Ramathibodi Hospital, Chonburi Hospital, Chonpratarn Hospital, Vachira Hospital, and Pathumthani Hospital
Participants:
Adult patients age 18 years or older and non-pregnant in women who have been diagnosed as gangrenous or ruptured appendicitis.
Outcome:
Superficial surgical site infection
Period of study:
August 2012 - August 2014
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary wound closure | Experimental | Procedure: Primary wound closureA wound will be sutured immediately after the operative procedure uisng non-absorbable monofilament suture or stapler at intervals of one centimeter apart and 0.5 cm back from a wound edge. |
| Delayed primary wound closure | Active comparator | Procedure: Primary wound closureA wound will be left open with saline-soaked gauze packing after the operative procedure and will be sutured around day 3 to 7 after operation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adult patients age 18 years or older
- Have been diagnosed as gangrenous or ruptured appendicitis base on clinical criteria with the following conditions
- a.Gangrenous appendicitis i.Erythematous or swelling of appendix and ii.Appearance of necrotic wall (dark, grayish color) b.Ruptured appendicitis i. Erythematous or swelling of appendix and ii.Appearance of hole in an appendix or iii.Rupture of appendix during a procedure c.Appearance of frank pus
- Non-immunocompromised hosts which include
- Non-pregnant women
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Primary wound closureA wound will be sutured immediately after the operative procedure uisng non-absorbable monofilament suture or stapler at intervals of one centimeter apart and 0.5 cm back from a wound edge. | Procedure or surgery | Delayed primary wound closure, Primary wound closure |
Primary outcome
Superficial surgical site infection (SSI)
Time frame: within 1 month after operation
Superficial SSI, which will be diagnosed using the Center for Disease Control (CDC) criteria as follows: * Infection within 30 days and * Involves only skin and subcutaneous tissue of the incision and * One of the following: * Purulent drainage, * organism isolated from culture of fluid or tissue * one of the following signs or symptoms: * pain or tenderness; * localized, swelling, redness, or * heat And the superficial incision is deliberately opened by surgeon
3 secondary outcomes
postoperative pain
Time frame: within 3 days after operation
Quality of life
Time frame: 1 month after operation
Cost of treatment
Time frame: 1 month 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 6 Apr 2016.
- Derived from this study: PubMed 29946346Noorit P, Siribumrungwong B, Thakkinstian A. Clinical prediction score for superficial surgical site infection after appendectomy in adults with complicated appendicitis. World J Emerg Surg. 2018 Jun 18;13:23. doi: 10.1186/s13017-018-0186-1. eCollection 2018.
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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.
Boonying Siribumrungwong, MD principal investigator
Ramathibodi Hospital
Ammarin Thakkinstian, PhD study chair
Ramathibodi Hospital
Patarawan Woratanarat study chair
Ramathibodi Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Primary wound closure in people with Surgical Site Infection, run by Ramathibodi Hospital at 7 sites in Thailand.
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 12 inclusion and 0 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 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Thailand. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Superficial surgical site infection (SSI) (time frame: within 1 month after operation). 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 NCT01659983, 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 6 Apr 2016.