Wound Infection; Wounds; Dehisence; Cosmesis; Home Care; Length of Hospital StayPROPELNCT03871023
Prophylactic Negative Wound Therapy in Laparotomy Wounds.
A study testing Smith & Nephew PICO Negative wound pressure versus standard dresing and PREVENA Negative pressure wound versus standard dressing in people with Wound Infection; Wounds; Dehisence; Cosmesis; Home Care; Length of Hospital Stay, run by St. James's Hospital, Ireland at 1 site in Ireland.
Trial summary
Post-operative wound issues in abdominal surgery have a significant impact on patient outcomes. The impact of different types of wound therapy are not clear in the literature. The hypothesis of this study is that NPWT has the potential to reduce Surgical Site Infections, however no study has compared the most commonly… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Infection; Wounds; Dehisence; Cosmesis; Home Care; Length of Hospital Stay
- What is being tested?
- Smith & Nephew PICO Negative wound pressure versus standard dresing and PREVENA Negative pressure wound versus standard dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteIreland
- Study dates
- 6 Nov 2019to 1 Dec 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients over the age of 18 years of age undergoing a laparotomy are eligible for entry into this study. Benign and malignant conditions are eligible for inclusion.
Who cannot join
- Pregnant patients and those undergoing re-look laparotomies are to be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Prophylactic Negative Wound Therapy in Emergency and Elective Laparotomy Wounds
Post-operative wound issues in abdominal surgery have a significant impact on patient outcomes. The impact of different types of wound therapy are not clear in the literature.
The hypothesis of this study is that NPWT has the potential to reduce Surgical Site Infections, however no study has compared the most commonly used products against standard dressings.
Read the detailed description
In the era of enhanced recovery, improving modifiable peri-operative and post-operative factors is essential to better patient outcomes. Surgical site complications in the form of wound infections are a major burden to the healthcare system. Negative pressure wound therapy (NPWT) as delivered by a surgical incision management system (SIMS) is a novel approach to improve wound healing when applied to closed incisions.
However, data is limited in its application to laparotomy incisions in the acute and elective care surgery setting. Surgical site infections can complicate a patient's post-operative course significantly, often necessitating a longer length of stay, antibiotic therapy, intervention for wound collections and impair patient mobility and overall recovery.
In addition to this, laparotomy wound complications can possibly delay adjuvant therapy and also increases healthcare costs both as an inpatient and in the community. Despite significant measures to reduce such complications in the form of wound care bundles, changing of gloves prior to wound closure etc, surgical site complications continue to represent a huge healthcare burden.
Aim;
- To determine if prophylactic negative pressure wound therapy confers a lower rate of Superficial Site Infection or reduces wound complications in Emergency or Elective Laparotomy wounds thereby improving post-operative patient recovery and reducing healthcare costs.
- Being tested
- Smith & Nephew PICO Negative wound pressure versus standard dresing, PREVENA Negative pressure wound versus standard dressing
- Medical subject headings
- Wound Infection, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smith & Nephew PICO Negative wound pressure versus standard dresingDevice
To investigate if negative wound pressure improves wound outcome
PREVENA Negative pressure wound versus standard dressingDevice
To investigate if negative wound pressure improves wound outcome
| Study group | Role | What they receive |
|---|---|---|
| Simple dressing | Active comparator | Standard, waterproof dressing applied to wound Receives: Device: Smith & Nephew PICO Negative wound pressure versus standard dresing; Device: PREVENA Negative pressure wound versus standard dressing |
| PICO Dressing | Active comparator | Negative Wound pressure applied second cohort Receives: Device: PREVENA Negative pressure wound versus standard dressing |
| PREVENA Dressing | Active comparator | Negative wound presure applied to third cohort Receives: Device: Smith & Nephew PICO Negative wound pressure versus standard dresing |
What is being measured
The primary outcome is the main question the study is designed to answer.
superficial site infection via southampton scoring system (higher score - worse outcome)
seroma/haematoma/abscess formation
Measured: 5 days
Wound Dehisence
disruption of wound continuity
Measured: 5 days
Secondary outcomes (3)
Wound healing/Cosmesis
scar healing (via observer scar assesment scale - higher score wore outcome)
Measured: week 6 post op
Length of hospital stay
wound complications causing prolonged hospital stay
Measured: 30 days
home care therapy
lenth of home care dressings
Measured: 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start6 Nov 2019 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
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 Wound Infection; Wounds; Dehisence; Cosmesis; Home Care; Length of Hospital StayStudies 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
- 3 separate treatment arms
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. James's Hospital, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noel Edward Donlon, St. James's Hospital, Ireland
- Investigators
- Noel E Donlon, Principal investigator, St. James's Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871023
- Sponsor's protocol ID
- SJH0519
- Acronym
- PROPEL
- Status last verified
- Sep 2019
- First submitted
- 7 Mar 2019
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deleted post analysis
Publications
Donlon NE, Boland PA, Kelly ME, Schmidt K, Cooke F, Neary PM, Barry KM, Reynolds JV. Prophylactic negative wound therapy in laparotomy wounds (PROPEL trial): randomized controlled trial. Int J Colorectal Dis. 2019 Nov;34(11):2003-2010. doi: 10.1007/s00384-019-03398-9. Epub 2019 Sep 16.
PubMed 31529194
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Prophylactic Negative Wound Therapy in Emergency and Elective Laparotomy Wounds
- ClinicalTrials.gov ID
- NCT03871023
- Acronym / sponsor ID
- PROPEL / SJH0519
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- St. James's Hospital, IrelandUniversity, hospital or other
- Study start
- 6 Nov 2019 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 12 Mar 2019 (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.
Post-operative wound issues in abdominal surgery have a significant impact on patient outcomes. The impact of different types of wound therapy are not clear in the literature.
The hypothesis of this study is that NPWT has the potential to reduce Surgical Site Infections, however no study has compared the most commonly used products against standard dressings.
Detailed description
In the era of enhanced recovery, improving modifiable peri-operative and post-operative factors is essential to better patient outcomes. Surgical site complications in the form of wound infections are a major burden to the healthcare system. Negative pressure wound therapy (NPWT) as delivered by a surgical incision management system (SIMS) is a novel approach to improve wound healing when applied to closed incisions.
However, data is limited in its application to laparotomy incisions in the acute and elective care surgery setting. Surgical site infections can complicate a patient's post-operative course significantly, often necessitating a longer length of stay, antibiotic therapy, intervention for wound collections and impair patient mobility and overall recovery.
In addition to this, laparotomy wound complications can possibly delay adjuvant therapy and also increases healthcare costs both as an inpatient and in the community. Despite significant measures to reduce such complications in the form of wound care bundles, changing of gloves prior to wound closure etc, surgical site complications continue to represent a huge healthcare burden.
Aim;
- To determine if prophylactic negative pressure wound therapy confers a lower rate of Superficial Site Infection or reduces wound complications in Emergency or Elective Laparotomy wounds thereby improving post-operative patient recovery and reducing healthcare costs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- 3 separate treatment arms
| Arm | Type | Receives |
|---|---|---|
| Simple dressing | Active comparator | Device: Smith & Nephew PICO Negative wound pressure versus standard dresing, Device: PREVENA Negative pressure wound versus standard dressingStandard, waterproof dressing applied to wound |
| PICO Dressing | Active comparator | Device: PREVENA Negative pressure wound versus standard dressingNegative Wound pressure applied second cohort |
| PREVENA Dressing | Active comparator | Device: Smith & Nephew PICO Negative wound pressure versus standard dresingNegative wound presure applied to third cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients over the age of 18 years of age undergoing a laparotomy are eligible for entry into this study. Benign and malignant conditions are eligible for inclusion.
Key exclusion criteria (1 listed)
- Pregnant patients and those undergoing re-look laparotomies are to be excluded.
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 |
|---|---|---|
| Smith & Nephew PICO Negative wound pressure versus standard dresingTo investigate if negative wound pressure improves wound outcome | Device | PREVENA Dressing, Simple dressing |
| PREVENA Negative pressure wound versus standard dressingTo investigate if negative wound pressure improves wound outcome | Device | PICO Dressing, Simple dressing |
Primary outcome
superficial site infection via southampton scoring system (higher score - worse outcome)
Time frame: 5 days
seroma/haematoma/abscess formation
Wound Dehisence
Time frame: 5 days
disruption of wound continuity
3 secondary outcomes
Wound healing/Cosmesis
Time frame: week 6 post op
Length of hospital stay
Time frame: 30 days
home care therapy
Time frame: 30days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Derived from this study: PubMed 31529194Donlon NE, Boland PA, Kelly ME, Schmidt K, Cooke F, Neary PM, Barry KM, Reynolds JV. Prophylactic negative wound therapy in laparotomy wounds (PROPEL trial): randomized controlled trial. Int J Colorectal Dis. 2019 Nov;34(11):2003-2010. doi: 10.1007/s00384-019-03398-9. Epub 2019 Sep 16.
- Individual participant dataSharing planned: No. Deleted post analysis
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.
Noel E Donlon principal investigator
St. James's Hospital, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smith & Nephew PICO Negative wound pressure versus standard dresing and PREVENA Negative pressure wound versus standard dressing in people with Wound Infection; Wounds; Dehisence; Cosmesis; Home Care; Length of Hospital Stay, run by St. James's Hospital, Ireland at 1 site in Ireland.
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: status not confirmed, as of the sponsor's last update on 18 Sep 2019. 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 Ireland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noel E Donlon (00353863557726 ext. 00353863557726, donlonn@tcd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
superficial site infection via southampton scoring system (higher score - worse outcome) (time frame: 5 days). The study lists 2 primary outcomes in all. 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 NCT03871023, 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 18 Sep 2019.