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NCT Number: NCT05977816

PROPEL-2: Prophylactic Negative Pressure Wound Therapy in Laparotomy Wounds

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Wound Surgical Cosmesis Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Surgical Wound Infection Wound Infection Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo University Hospital, Castlebar, Ireland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years or older
  • Patient requires visceral abdominal surgery via a midline laparotomy
  • Patients who can complete questionnaires

Exclusion criteria

  • Patients who are unable to adhere to protocol requirements

Treatment and study plan

Negative pressure wound therapy

Device

Application of a negative wound pressure therapy dressing to the wound post laparotomy

Standard wound dressing

Other

Application of a standard wound dressing to the wound post laparotomy

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)

    Time frame: Baseline

    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)

  2. Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)

    Time frame: 1 month following surgery

    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)

  3. Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)

    Time frame: 3 months following surgery

    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)

  4. Health-related quality of life with the EuroQol-5 dimensions five level index questionnaire (EQ-5D-5L)

    Time frame: 6 months following surgery

    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)

  5. Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)

    Time frame: 1 month following surgery

    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

  6. Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)

    Time frame: 3 months following surgery

    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

  7. Scar assessment - using the Patient and Observer Scar Assessment Scale (POSAS)

    Time frame: 6 months following surgery

    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

  8. Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)

    Time frame: 1 month

    The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition

  9. Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)

    Time frame: 3 months

    The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition

  10. Health-related out-of- Pocket Costs assessed using the Costs for Patients Questionnaire (CoPaQ)

    Time frame: 6 months

    The CoPaQ measures patient and caregivers out-of-pocket expenses (direct and indirect) associated with a health condition

  11. Health Economics evaluation of resource use and cost effectiveness using Negative Pressure Wound Therapy dressings

    Time frame: 6 months

    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

  12. Healthcare incremental cost- utility ratio

    Time frame: 6 months

    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

  13. Healthcare cost-effectiveness ratio at 6 months

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Royal College of Surgeons, Ireland

Other

Registry information

Official study 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

Acronym: PROPEL-2

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 4, 2023
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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