Surgical Site InfectionOPTIWOUNDNCT05716490
Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy
A study testing Incisional negative pressure wound therapy in people with Surgical Site Infection and Surgical Wound, run by Centro Hospitalar do Tâmega e Sousa at 1 site in Portugal.
Trial summary
The purpose of this study is to find differences in rates of surgical site infections following emergency laparotomy with the use of two different incisional negative pressure wound therapy (iNPWT)devices. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Surgical Site Infection, Surgical Wound, Surgical Wound Infection
- What is being tested?
- Incisional negative pressure wound therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jul 2022to 1 Sep 2023
- Phase
- Interventional
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients proposed for emergency laparotomy
Who cannot join
- Contra-indication for iNPWT
- Irreversible disease diagnosis with expected short term mortality
- Need for a staged procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy: A Multi-arm Randomized Prospective Trial
The purpose of this study is to find differences in rates of surgical site infections following emergency laparotomy with the use of two different incisional negative pressure wound therapy (iNPWT)devices.
Read the detailed description
A multi-arm, randomized, single institution trial was conducted. All patients proposed for emergency laparotomy for different etiologies where considered eligible. Patients were enrolled following signature of informed consent.
Excluded from this group were patients with recent previous interventions (laparotomy or minimally invasive surgery), patients not wishing a iNPWT device or patients with specific contraindications to any device.
Later where excluded from the study patients on laparostomy, Intraoperative diagnosis of irreversible disease (Ex: Extensive mesenteric ischemia).
Following enrollment patients were randomized to 3 groups - control group with standard dressings; PICO group with Pico® (Smith \& Nephew Inc, Andover, MA) dressing and Prevena group using Prevena® (KCI USA, Inc., San Antonio, TX) dressing.
Following admission the patients were monitored for surgical site occurrences and other complications by the investigation team until discharge. Subsequent 2 week post-operative evaluation (if patient had been discharged) was carried out in outpatient.
A final consultation was made 30 days postoperatively.
- Conditions
- Surgical Site Infection, Surgical Wound, Surgical Wound Infection, Surgical Complication, Surgical Wound Dehiscence, Surgical Wound Haemorrhage
- Being tested
- Incisional negative pressure wound therapy, Control group - standard wound dressing
- Keywords
- iNPWT, Incision negative pressure wound therapy, emergency laparotomy, general surgery, surgical site infection
- Medical subject headings
- Surgical Wound Infection, Surgical Wound, Surgical Wound Dehiscence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incisional negative pressure wound therapyDevice
Application of negative pressure wound therapy for prophylaxis of surgical site occurrences
Control group - standard wound dressingOther
Covering of surgical wound with standard wound dressing
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | Control group which will cover surgical wound with conventional wound dressing Receives: Other: Control group - standard wound dressing |
| PICO | Experimental | Group that will use Pico® device for wound dressing Receives: Device: Incisional negative pressure wound therapy |
| PREVENA | Experimental | Group that will use Prevena® device for wound dressing Receives: Device: Incisional negative pressure wound therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
Surgical site infection following emergency laparotomy
Measured: 30 days
Secondary outcomes (1)
Surgical site occurrences
Seroma, hematoma, wound dehiscence
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Jul 2022
- Primary completion1 Aug 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are enrolled chronologically at the time of surgery into a slot of a previously randomized table with the 3 interventional arms
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar do Tâmega e Sousa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcelo José Maia Azevedo Costa, Centro Hospitalar do Tâmega e Sousa
- Investigators
- Marcelo J Costa, MD, Principal investigator, Centro Hospitalar do Tâmega e Sousa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05716490
- Sponsor's protocol ID
- 29/2022
- Acronym
- OPTIWOUND
- Status last verified
- Nov 2023
- First submitted
- 28 Jan 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Closed Incision Negative Pressure Wound Therapy in Emergency Laparotomy: A Multi-arm Randomized Prospective Trial
- ClinicalTrials.gov ID
- NCT05716490
- Acronym / sponsor ID
- OPTIWOUND / 29/2022
- Conditions
- Surgical Site Infection, Surgical Wound, Surgical Wound Infection, Surgical Complication, Surgical Wound Dehiscence, Surgical Wound Haemorrhage
- Keywords
- iNPWT, Incision negative pressure wound therapy, emergency laparotomy, general surgery, surgical site infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Centro Hospitalar do Tâmega e SousaUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 8 Feb 2023 (actual)
- 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 study is to find differences in rates of surgical site infections following emergency laparotomy with the use of two different incisional negative pressure wound therapy (iNPWT)devices.
Detailed description
A multi-arm, randomized, single institution trial was conducted. All patients proposed for emergency laparotomy for different etiologies where considered eligible. Patients were enrolled following signature of informed consent.
Excluded from this group were patients with recent previous interventions (laparotomy or minimally invasive surgery), patients not wishing a iNPWT device or patients with specific contraindications to any device.
Later where excluded from the study patients on laparostomy, Intraoperative diagnosis of irreversible disease (Ex: Extensive mesenteric ischemia).
Following enrollment patients were randomized to 3 groups - control group with standard dressings; PICO group with Pico® (Smith \& Nephew Inc, Andover, MA) dressing and Prevena group using Prevena® (KCI USA, Inc., San Antonio, TX) dressing.
Following admission the patients were monitored for surgical site occurrences and other complications by the investigation team until discharge. Subsequent 2 week post-operative evaluation (if patient had been discharged) was carried out in outpatient.
A final consultation was made 30 days postoperatively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients are enrolled chronologically at the time of surgery into a slot of a previously randomized table with the 3 interventional arms
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Other: Control group - standard wound dressingControl group which will cover surgical wound with conventional wound dressing |
| PICO | Experimental | Device: Incisional negative pressure wound therapyGroup that will use Pico® device for wound dressing |
| PREVENA | Experimental | Device: Incisional negative pressure wound therapyGroup that will use Prevena® device for wound dressing |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients proposed for emergency laparotomy
Key exclusion criteria (3 listed)
- Contra-indication for iNPWT
- Irreversible disease diagnosis with expected short term mortality
- Need for a staged procedure
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 |
|---|---|---|
| Incisional negative pressure wound therapyApplication of negative pressure wound therapy for prophylaxis of surgical site occurrences | Device | PICO, PREVENA |
| Control group - standard wound dressingCovering of surgical wound with standard wound dressing | Other | Standard |
Primary outcome
Surgical site infection
Time frame: 30 days
Surgical site infection following emergency laparotomy
1 secondary outcome
Surgical site occurrences
Time frame: 30 days
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 13 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Marcelo J Costa, MD principal investigator
Centro Hospitalar do Tâmega e Sousa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incisional negative pressure wound therapy in people with Surgical Site Infection and Surgical Wound, run by Centro Hospitalar do Tâmega e Sousa at 1 site in Portugal.
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 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 13 Nov 2023. 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 Portugal. 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.
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?
Surgical site infection (time frame: 30 days). 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 13 Nov 2023.