Wound SurgicalPROPEL-2NCT05977816
PROPEL-2: Prophylactic Negative Pressure Wound Therapy in Laparotomy Wounds
A study testing Negative Pressure Wound Therapy and Standard wound dressing in people with Wound Surgical and Wound Infection, run by Royal College of Surgeons, Ireland at 10 sites in Ireland.
Trial summary
Post-operative wound issues in abdominal surgery have a significant impact on patient outcomes. This study is taking place to investigate if Negative Pressure Wound Therapy (NPWT) dressings reduces Surgical Site Infections, post surgical complications and improves scar appearance compared to standard dressings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Surgical, Wound Infection, Cosmesis
- What is being tested?
- Negative Pressure Wound Therapy and Standard wound dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 10 sitesIreland
- Study dates
- 14 Jul 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Aged 18 years or older
- Patient requires visceral abdominal surgery via a midline laparotomy
- Patients who can complete questionnaires
Who cannot join
- Patients who are unable to adhere to protocol requirements
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Ireland10 sites
Mayo University Hospital
Castlebar
Beaumont Hospital
Dublin
Mater Misericordiae University Hospital
Dublin
St James's Hospital
Dublin
Tallaght University Hospital
Dublin
University Hospital Galway
Galway
Letterkenny University Hospital
Letterkenny
University Hospital Limerick
Limerick
Sligo University Hospital
Sligo
University Hospital Waterford
Waterford
About this study
Official title: PROPEL-2 Prophylactic Negative Pressure Wound Therapy (NPWT) in Laparotomy Wounds: a Randomised Controlled Trial Comparing Negative Pressure Wound Therapy to Standard Wound Management in Patients Following Midline Laparotomy
Post-operative wound issues in abdominal surgery have a significant impact on patient outcomes. This study is taking place to investigate if Negative Pressure Wound Therapy (NPWT) dressings reduces Surgical Site Infections, post surgical complications and improves scar appearance compared to standard dressings.
Read the detailed description
NPWT dressings are designed to remove and absorb any fluid leaking from the wound. This might reduce surgical site infections, improve wound healing and improve scar appearance compared to using standard dressings.
Data is limited in the application of NPWT dressings 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.
The Investigators are conducting this study to determine whether NPWT dressings reduce surgical site infections, improve wound healing and scar appearance. This study will also involve a cost-based analysis and seek information from patients on their quality of life. Results from this study will provide evidence on whether these dressings should be used as standard of care for management of surgical laparotomy wounds.
- Conditions
- Wound Surgical, Wound Infection, Cosmesis
- Being tested
- Negative Pressure Wound Therapy, Standard wound dressing
- Keywords
- Negative Pressure Wound Therapy, Surgical site Infection, Laparotomy, Post-operative Complications, Abdominal Incision, health economics, POSAS, CoPaQ
- Medical subject headings
- Surgical Wound, Wound Infection, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative Pressure Wound TherapyDevice
Application of a negative wound pressure therapy dressing to the wound post laparotomy
Standard wound dressingOther
Application of a standard wound dressing to the wound post laparotomy
| Study group | Role | What they receive |
|---|---|---|
| Negative Pressure Wound Therapy | Experimental | The wound is dressed using negative pressure wound therapy. Receives: Device: Negative Pressure Wound Therapy |
| Standard Wound dressing | Active comparator | After the skin is closed, the wound is covered using sterile standard gauze dressing. Receives: Other: Standard wound dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Surgical Site Infection (SSI)
To compare the rate of surgical site infections within 1 month of the surgical procedure, using Negative Pressure Wound Therapy compared to standard dressings. SSIs will be classified according to Centre for Disease Control (CDC) criteria.
Measured: 1 month following surgery
Rate of Surgical Site Infection (SSI)
To compare the rate of surgical site infections within 3 months of the surgical procedure, using Negative Pressure Wound Therapy compared to standard dressings. SSIs will be classified according to Centre for Disease Control (CDC) criteria.
Measured: 3 months following surgery
Rate of Surgical Site Infection (SSI)
To compare the rate of surgical site infections within 6 months of the surgical procedure, using Negative Pressure Wound Therapy compared to standard dressings. SSIs will be classified according to Centre for Disease Control (CDC) criteria.
Measured: 6 months following surgery
Secondary outcomes (13)
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)
Measured: Baseline
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)
Measured: 1 month following surgery
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)
Measured: 3 months following surgery
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
The questionnaire covers five dimensions of health: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. The raw scores are also converted to an EQ-5D index value using a scoring algorithm (British tariff) ranging from -0.594 (worst perceived health state) to 1.00 (best perceived health state)
Measured: 6 months following surgery
Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)
The POSAS is made up of two scales: the patient scale and the observer scale; each of the six components is scored numerically on a scale of 1 to 10. The component scores are then added together; the worst scar would receive a score of 60, while the best scar would receive a score of 6
Measured: 1 month following surgery
Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)
The POSAS is made up of two scales: the patient scale and the observer scale; each of the six components is scored numerically on a scale of 1 to 10. The component scores are then added together; the worst scar would receive a score of 60, while the best scar would receive a score of 6
Measured: 3 months following surgery
Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)
The POSAS is made up of two scales: the patient scale and the observer scale; each of the six components is scored numerically on a scale of 1 to 10. The component scores are then added together; the worst scar would receive a score of 60, while the best scar would receive a score of 6
Measured: 6 months following surgery
Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)
The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition
Measured: 1 month
Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)
The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition
Measured: 3 months
Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)
The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition
Measured: 6 months
Health Economics evaluation of resource use and cost effectiveness using Negative Pressure Wound Therapy dressings
Investigating resource use and cost effectiveness of single-use, prophylactic negative pressure wound therapy versus standard dressings for midline laparotomy wounds based on length of hospital stay and costs of dressings
Measured: 6 months
Healthcare incremental cost- utility ratio
The incremental cost-effectiveness ratio at 6 months for NPWT vesus standard dressings for patients undergoing laparotomy.The effectiveness will be expressed as quality adjusted life years (QALYs) in a cost-utility analysis. QALYs are a composite measure of outcomes where utilities for health states (on 0-1 scale, where 0 corresponds to death and 1 to full health) act as qualitative weights to combine quantity and quality of life. The number of QALYs in each group will be assessed with the EuroQol 5 Dimensions questionnaire (EQ5D). The EQ-5D measures health status in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression
Measured: 6 months
Healthcare cost-effectiveness ratio at 6 months
Assessment of the cost-effectiveness ratio at 6 months between NPWT dressings compared to standard dressings. The criteria of effectiveness used will be; Length of hospital stay, requirement for return to theatre, requirement for critical care and number of dressings used
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start14 Jul 2023
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (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 SurgicalStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Donohoe, PhD, FRCSI, Principal investigator, Trinity College Dublin /Royal College of Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977816
- Sponsor's protocol ID
- RCSI 22-092
- Acronym
- PROPEL-2
- Status last verified
- Jul 2026
- First submitted
- 13 Feb 2023
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Davey MG, Donlon NE, Walsh SR, Donohoe CL; PROPEL-2 Trial Collaborators. Prophylactic negative pressure wound therapy (NPWT) in laparotomy wounds (PROPEL-2): protocol for a randomized clinical trial. BJS Open. 2024 Jul 2;8(4):zrae081. doi: 10.1093/bjsopen/zrae081.
PubMed 39178168
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROPEL-2 Prophylactic Negative Pressure Wound Therapy (NPWT) in Laparotomy Wounds: a Randomised Controlled Trial Comparing Negative Pressure Wound Therapy to Standard Wound Management in Patients Following Midline Laparotomy
- ClinicalTrials.gov ID
- NCT05977816
- Acronym / sponsor ID
- PROPEL-2 / RCSI 22-092
- Conditions
- Wound Surgical, Wound Infection, Cosmesis
- Keywords
- Negative Pressure Wound Therapy, Surgical site Infection, Laparotomy, Post-operative Complications, Abdominal Incision, health economics, POSAS, CoPaQ
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Aug 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.
Post-operative wound issues in abdominal surgery have a significant impact on patient outcomes. This study is taking place to investigate if Negative Pressure Wound Therapy (NPWT) dressings reduces Surgical Site Infections, post surgical complications and improves scar appearance compared to standard dressings.
Detailed description
NPWT dressings are designed to remove and absorb any fluid leaking from the wound. This might reduce surgical site infections, improve wound healing and improve scar appearance compared to using standard dressings.
Data is limited in the application of NPWT dressings 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.
The Investigators are conducting this study to determine whether NPWT dressings reduce surgical site infections, improve wound healing and scar appearance. This study will also involve a cost-based analysis and seek information from patients on their quality of life. Results from this study will provide evidence on whether these dressings should be used as standard of care for management of surgical laparotomy wounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Negative Pressure Wound Therapy | Experimental | Device: Negative Pressure Wound TherapyThe wound is dressed using negative pressure wound therapy. |
| Standard Wound dressing | Active comparator | Other: Standard wound dressingAfter the skin is closed, the wound is covered using sterile standard gauze dressing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 years or older
- Patient requires visceral abdominal surgery via a midline laparotomy
- Patients who can complete questionnaires
Key exclusion criteria (1 listed)
- Patients who are unable to adhere to protocol requirements
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 |
|---|---|---|
| Negative Pressure Wound TherapyApplication of a negative wound pressure therapy dressing to the wound post laparotomy | Device | Negative Pressure Wound Therapy |
| Standard wound dressingApplication of a standard wound dressing to the wound post laparotomy | Other | Standard Wound dressing |
Primary outcome
Rate of Surgical Site Infection (SSI)
Time frame: 1 month following surgery
To compare the rate of surgical site infections within 1 month of the surgical procedure, using Negative Pressure Wound Therapy compared to standard dressings. SSIs will be classified according to Centre for Disease Control (CDC) criteria.
Rate of Surgical Site Infection (SSI)
Time frame: 3 months following surgery
To compare the rate of surgical site infections within 3 months of the surgical procedure, using Negative Pressure Wound Therapy compared to standard dressings. SSIs will be classified according to Centre for Disease Control (CDC) criteria.
Rate of Surgical Site Infection (SSI)
Time frame: 6 months following surgery
To compare the rate of surgical site infections within 6 months of the surgical procedure, using Negative Pressure Wound Therapy compared to standard dressings. SSIs will be classified according to Centre for Disease Control (CDC) criteria.
13 secondary outcomes
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
Time frame: Baseline
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
Time frame: 1 month following surgery
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
Time frame: 3 months following surgery
Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)
Time frame: 6 months following surgery
Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)
Time frame: 1 month following surgery
Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)
Time frame: 3 months following surgery
Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)
Time frame: 6 months following surgery
Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)
Time frame: 1 month
Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)
Time frame: 3 months
Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)
Time frame: 6 months
Health Economics evaluation of resource use and cost effectiveness using Negative Pressure Wound Therapy dressings
Time frame: 6 months
Healthcare incremental cost- utility ratio
Time frame: 6 months
Healthcare cost-effectiveness ratio at 6 months
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Derived from this study: PubMed 39178168Davey MG, Donlon NE, Walsh SR, Donohoe CL; PROPEL-2 Trial Collaborators. Prophylactic negative pressure wound therapy (NPWT) in laparotomy wounds (PROPEL-2): protocol for a randomized clinical trial. BJS Open. 2024 Jul 2;8(4):zrae081. doi: 10.1093/bjsopen/zrae081.
- Individual participant dataSharing planned: No
Related trials for Wound Surgical
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
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.
Claire Donohoe, PhD, FRCSI principal investigator
Trinity College Dublin /Royal College of Surgeons
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative Pressure Wound Therapy and Standard wound dressing in people with Wound Surgical and Wound Infection, run by Royal College of Surgeons, Ireland at 10 sites 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 3 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: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Rate of Surgical Site Infection (SSI) (time frame: 1 month following surgery). The study lists 3 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 NCT05977816, 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 21 Jul 2026.