Ventral HerniaN-PITHNCT04455724
Negative Pressure Incisional Wound Therapy for High-risk Ventral Hernia Repair
A study testing Negative pressure incisional wound therapy and Standard sterile dressing in people with Ventral Hernia, run by McMaster University at 1 site in Canada.
Trial summary
The investigators are testing the ability of vacuum dressings to improve wound healing for patients having large hernias surgically repaired who are at risk of having wound complications. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Negative pressure incisional wound therapy and Standard sterile dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- 14 Dec 2020to 1 May 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients undergoing surgical repair of ventral or incisional hernias greater than 3 cm in largest diameter
- have one or more of the following risk factors for post-operative surgical site complications:
- Body Mass Index (BMI) greater than or equal to 30
- diagnosis of diabetes mellitus (either type I or II)
- previous history of hernia recurrence
- active smoker
Show all 11Show fewer
- presence of colostomy or ileostomy
- age greater than 64
- chronic obstructive pulmonary disease
- chronic kidney disease
- clinically immunocompromised.
Who cannot join
- the abdomen is left open post-operatively, or
- if the patient has a sensitivity to silver.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Niagara Health St. Catharines Site
St. Catharines, Ontario, L2R 2A8
About this study
Official title: Negative Pressure Incisional Wound Therapy for High-risk Ventral Hernia Repair: a Randomized Controlled Trial
The investigators are testing the ability of vacuum dressings to improve wound healing for patients having large hernias surgically repaired who are at risk of having wound complications. The trial will randomly be giving some patients having this surgery the vacuum dressing and some a standard dressing and observing how their wounds heal in hospital and at follow-up appointments.
Read the detailed description
This study is a multicentre, clinical randomized controlled trial comparing the use of incisional negative pressure wound therapy versus standard sterile dressings in high-risk ventral hernia repairs. The trial will be enrolling patients undergoing elective or emergent ventral hernia repair who have risk factors for surgical wound complications and randomizing them to either receive a PREVENA incisional negative pressure wound therapy system dressing for 7 days post-operatively or a standard sterile dressing.for 2 days post-operatively. The primary outcome will be a composite of a variety of surgical site complications including wound infection, dehiscence, seroma / hematoma formation, non-healing wound, early hernia recurrence, and fistula formation. These will be evaluated by unblinded clinical judgement of treating physicians, and blinded assessment with ultrasonography. Secondary outcomes will include perceived difference in Quality of Life and cost-effectiveness of the intervention.
- Conditions
- Ventral Hernia
- Being tested
- Negative pressure incisional wound therapy, Standard sterile dressing
- Medical subject headings
- Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Negative pressure incisional wound therapyDevice
A vacuum-style dressing system that is sealed in place over a surgical wound, applying constant negative pressure to the healing tissues.
Standard sterile dressingDevice
A standard, sterile island dressing
| Study group | Role | What they receive |
|---|---|---|
| Negative Pressure Incisional Wound Therapy | Experimental | A PREVENA™ PEEL \& PLACE™ system kit will be applied to the surgical wound and assembled in the operating room following closure by primary intent. The system will be set for a negative pressure of -125mmHg. The dressing will be left in place for 7 days post-operation, during which the patient may be discharged from hospital. The dressing will only be removed or changed if the treating physician has suspicion of one of the complications included in the primary composite outcome or is planning re-intervention on the surgical site. Receives: Device: Negative pressure incisional wound therapy |
| Standard sterile dressing | Active comparator | A sterile island dressing will be applied to the surgical wound in the operating room following closure by primary intent, which will be removed on post-operative day 2 and left open to air unless there is ongoing discharge. Receives: Device: Standard sterile dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Complications
Composite of incidence of surgical site infection, hematoma formation, seroma formation, wound dehiscence, hernia recurrence, and fistula formation.
Measured: First 3 months post-operatively
Secondary outcomes (2)
Quality of life after surgery: survey
Quality of life as measured using the Hernia-Related Quality of Life Survey (HerQLes). Scoring is out of 100, with higher scores indicating better quality of life.
Measured: 3 months post-operatively
Cost-effectiveness
Cost in dollars per quality-adjusted life year, measured using hospital length of stay, cost of complications, and cost of intervention
Measured: 3 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start14 Dec 2020
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher E Blewett, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455724
- Sponsor's protocol ID
- 8183
- Acronym
- N-PITH
- Status last verified
- Jun 2024
- First submitted
- 29 Jun 2020
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lindmark M, Strigard K, Lowenmark T, Dahlstrand U, Gunnarsson U. Risk Factors for Surgical Complications in Ventral Hernia Repair. World J Surg. 2018 Nov;42(11):3528-3536. doi: 10.1007/s00268-018-4642-6.
PubMed 29700567Nguyen MT, Berger RL, Hicks SC, Davila JA, Li LT, Kao LS, Liang MK. Comparison of outcomes of synthetic mesh vs suture repair of elective primary ventral herniorrhaphy: a systematic review and meta-analysis. JAMA Surg. 2014 May;149(5):415-21. doi: 10.1001/jamasurg.2013.5014.
PubMed 24554114Lee L, Mata J, Landry T, Khwaja KA, Vassiliou MC, Fried GM, Feldman LS. A systematic review of synthetic and biologic materials for abdominal wall reinforcement in contaminated fields. Surg Endosc. 2014 Sep;28(9):2531-46. doi: 10.1007/s00464-014-3499-5. Epub 2014 Mar 12.
PubMed 24619334Castro PM, Rabelato JT, Monteiro GG, del Guerra GC, Mazzurana M, Alvarez GA. Laparoscopy versus laparotomy in the repair of ventral hernias: systematic review and meta-analysis. Arq Gastroenterol. 2014 Jul-Sep;51(3):205-11. doi: 10.1590/s0004-2803201400030008.
PubMed 25296080Fischer JP, Wink JD, Nelson JA, Kovach SJ 3rd. Among 1,706 cases of abdominal wall reconstruction, what factors influence the occurrence of major operative complications? Surgery. 2014 Feb;155(2):311-9. doi: 10.1016/j.surg.2013.08.014.
PubMed 24433774Lovecchio F, Farmer R, Souza J, Khavanin N, Dumanian GA, Kim JY. Risk factors for 30-day readmission in patients undergoing ventral hernia repair. Surgery. 2014 Apr;155(4):702-10. doi: 10.1016/j.surg.2013.12.021. Epub 2013 Dec 25.
PubMed 24612622Badia JM, Casey AL, Petrosillo N, Hudson PM, Mitchell SA, Crosby C. Impact of surgical site infection on healthcare costs and patient outcomes: a systematic review in six European countries. J Hosp Infect. 2017 May;96(1):1-15. doi: 10.1016/j.jhin.2017.03.004. Epub 2017 Mar 8.
PubMed 28410761Correa NF, de Brito MJ, de Carvalho Resende MM, Duarte MF, Santos FS, Salome GM, Ferreira LM. Impact of surgical wound dehiscence on health-related quality of life and mental health. J Wound Care. 2016 Oct 2;25(10):561-570. doi: 10.12968/jowc.2016.25.10.561.
PubMed 27681586Gheorghe A, Moran G, Duffy H, Roberts T, Pinkney T, Calvert M. Health Utility Values Associated with Surgical Site Infection: A Systematic Review. Value Health. 2015 Dec;18(8):1126-37. doi: 10.1016/j.jval.2015.08.004. Epub 2015 Sep 26.
PubMed 26686800Guest JF, Fuller GW, Vowden P. Costs and outcomes in evaluating management of unhealed surgical wounds in the community in clinical practice in the UK: a cohort study. BMJ Open. 2018 Dec 14;8(12):e022591. doi: 10.1136/bmjopen-2018-022591.
PubMed 30552253Argenta LC, Morykwas MJ. Vacuum-assisted closure: a new method for wound control and treatment: clinical experience. Ann Plast Surg. 1997 Jun;38(6):563-76; discussion 577.
PubMed 9188971Capobianco CM, Zgonis T. An overview of negative pressure wound therapy for the lower extremity. Clin Podiatr Med Surg. 2009 Oct;26(4):619-31. doi: 10.1016/j.cpm.2009.08.002.
PubMed 19778692Ma Z, Li Z, Shou K, Jian C, Li P, Niu Y, Qi B, Yu A. Negative pressure wound therapy: Regulating blood flow perfusion and microvessel maturation through microvascular pericytes. Int J Mol Med. 2017 Nov;40(5):1415-1425. doi: 10.3892/ijmm.2017.3131. Epub 2017 Sep 13.
PubMed 28901392Morykwas MJ, Argenta LC, Shelton-Brown EI, McGuirt W. Vacuum-assisted closure: a new method for wound control and treatment: animal studies and basic foundation. Ann Plast Surg. 1997 Jun;38(6):553-62. doi: 10.1097/00000637-199706000-00001.
PubMed 9188970Orgill DP, Manders EK, Sumpio BE, Lee RC, Attinger CE, Gurtner GC, Ehrlich HP. The mechanisms of action of vacuum assisted closure: more to learn. Surgery. 2009 Jul;146(1):40-51. doi: 10.1016/j.surg.2009.02.002. Epub 2009 Apr 19. No abstract available.
PubMed 19541009
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Negative Pressure Incisional Wound Therapy for High-risk Ventral Hernia Repair: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04455724
- Acronym / sponsor ID
- N-PITH / 8183
- Conditions
- Ventral Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 2 Jul 2020 (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 investigators are testing the ability of vacuum dressings to improve wound healing for patients having large hernias surgically repaired who are at risk of having wound complications. The trial will randomly be giving some patients having this surgery the vacuum dressing and some a standard dressing and observing how their wounds heal in hospital and at follow-up appointments.
Detailed description
This study is a multicentre, clinical randomized controlled trial comparing the use of incisional negative pressure wound therapy versus standard sterile dressings in high-risk ventral hernia repairs. The trial will be enrolling patients undergoing elective or emergent ventral hernia repair who have risk factors for surgical wound complications and randomizing them to either receive a PREVENA incisional negative pressure wound therapy system dressing for 7 days post-operatively or a standard sterile dressing.for 2 days post-operatively. The primary outcome will be a composite of a variety of surgical site complications including wound infection, dehiscence, seroma / hematoma formation, non-healing wound, early hernia recurrence, and fistula formation. These will be evaluated by unblinded clinical judgement of treating physicians, and blinded assessment with ultrasonography. Secondary outcomes will include perceived difference in Quality of Life and cost-effectiveness of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative Pressure Incisional Wound Therapy | Experimental | Device: Negative pressure incisional wound therapyA PREVENA™ PEEL \& PLACE™ system kit will be applied to the surgical wound and assembled in the operating room following closure by primary intent. The system will be set for a negative pressure of -125mmHg. The dressing will be left in place for 7 days post-operation, during which the patient may be discharged from hospital. The dressing will only be removed or changed if the treating physician has suspicion of one of the complications included in the primary composite outcome or is planning re-intervention on the surgical site. |
| Standard sterile dressing | Active comparator | Device: Standard sterile dressingA sterile island dressing will be applied to the surgical wound in the operating room following closure by primary intent, which will be removed on post-operative day 2 and left open to air unless there is ongoing discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- patients undergoing surgical repair of ventral or incisional hernias greater than 3 cm in largest diameter
- have one or more of the following risk factors for post-operative surgical site complications:
Key exclusion criteria (2 listed)
- the abdomen is left open post-operatively, or
- if the patient has a sensitivity to silver.
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 incisional wound therapyA vacuum-style dressing system that is sealed in place over a surgical wound, applying constant negative pressure to the healing tissues. | Device | Negative Pressure Incisional Wound Therapy |
| Standard sterile dressingA standard, sterile island dressing | Device | Standard sterile dressing |
Primary outcome
Surgical Site Complications
Time frame: First 3 months post-operatively
Composite of incidence of surgical site infection, hematoma formation, seroma formation, wound dehiscence, hernia recurrence, and fistula formation.
2 secondary outcomes
Quality of life after surgery: survey
Time frame: 3 months post-operatively
Cost-effectiveness
Time frame: 3 months post-operatively
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 27 Jun 2024.
- Background: PubMed 29700567Lindmark M, Strigard K, Lowenmark T, Dahlstrand U, Gunnarsson U. Risk Factors for Surgical Complications in Ventral Hernia Repair. World J Surg. 2018 Nov;42(11):3528-3536. doi: 10.1007/s00268-018-4642-6.
- Background: PubMed 24554114Nguyen MT, Berger RL, Hicks SC, Davila JA, Li LT, Kao LS, Liang MK. Comparison of outcomes of synthetic mesh vs suture repair of elective primary ventral herniorrhaphy: a systematic review and meta-analysis. JAMA Surg. 2014 May;149(5):415-21. doi: 10.1001/jamasurg.2013.5014.
- Background: PubMed 24619334Lee L, Mata J, Landry T, Khwaja KA, Vassiliou MC, Fried GM, Feldman LS. A systematic review of synthetic and biologic materials for abdominal wall reinforcement in contaminated fields. Surg Endosc. 2014 Sep;28(9):2531-46. doi: 10.1007/s00464-014-3499-5. Epub 2014 Mar 12.
- Background: PubMed 25296080Castro PM, Rabelato JT, Monteiro GG, del Guerra GC, Mazzurana M, Alvarez GA. Laparoscopy versus laparotomy in the repair of ventral hernias: systematic review and meta-analysis. Arq Gastroenterol. 2014 Jul-Sep;51(3):205-11. doi: 10.1590/s0004-2803201400030008.
- Background: PubMed 24433774Fischer JP, Wink JD, Nelson JA, Kovach SJ 3rd. Among 1,706 cases of abdominal wall reconstruction, what factors influence the occurrence of major operative complications? Surgery. 2014 Feb;155(2):311-9. doi: 10.1016/j.surg.2013.08.014.
- Background: PubMed 24612622Lovecchio F, Farmer R, Souza J, Khavanin N, Dumanian GA, Kim JY. Risk factors for 30-day readmission in patients undergoing ventral hernia repair. Surgery. 2014 Apr;155(4):702-10. doi: 10.1016/j.surg.2013.12.021. Epub 2013 Dec 25.
- Background: PubMed 28410761Badia JM, Casey AL, Petrosillo N, Hudson PM, Mitchell SA, Crosby C. Impact of surgical site infection on healthcare costs and patient outcomes: a systematic review in six European countries. J Hosp Infect. 2017 May;96(1):1-15. doi: 10.1016/j.jhin.2017.03.004. Epub 2017 Mar 8.
- Background: PubMed 27681586Correa NF, de Brito MJ, de Carvalho Resende MM, Duarte MF, Santos FS, Salome GM, Ferreira LM. Impact of surgical wound dehiscence on health-related quality of life and mental health. J Wound Care. 2016 Oct 2;25(10):561-570. doi: 10.12968/jowc.2016.25.10.561.
- Background: PubMed 26686800Gheorghe A, Moran G, Duffy H, Roberts T, Pinkney T, Calvert M. Health Utility Values Associated with Surgical Site Infection: A Systematic Review. Value Health. 2015 Dec;18(8):1126-37. doi: 10.1016/j.jval.2015.08.004. Epub 2015 Sep 26.
- Background: PubMed 30552253Guest JF, Fuller GW, Vowden P. Costs and outcomes in evaluating management of unhealed surgical wounds in the community in clinical practice in the UK: a cohort study. BMJ Open. 2018 Dec 14;8(12):e022591. doi: 10.1136/bmjopen-2018-022591.
- Background: PubMed 9188971Argenta LC, Morykwas MJ. Vacuum-assisted closure: a new method for wound control and treatment: clinical experience. Ann Plast Surg. 1997 Jun;38(6):563-76; discussion 577.
- Background: PubMed 19778692Capobianco CM, Zgonis T. An overview of negative pressure wound therapy for the lower extremity. Clin Podiatr Med Surg. 2009 Oct;26(4):619-31. doi: 10.1016/j.cpm.2009.08.002.
- Individual participant dataSharing planned: No
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SUTURE TYPE AND RECURRENCE RISK AFTER INCISIONAL HERNIA REPAIR
Ventral Incisional Hernia
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.
Christopher E Blewett, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Negative pressure incisional wound therapy and Standard sterile dressing in people with Ventral Hernia, run by McMaster University at 1 site in Canada.
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 11 inclusion and 2 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 27 Jun 2024. 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 Canada. 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 Complications (time frame: First 3 months post-operatively). 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 NCT04455724, which also lists 33 linked publications.
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 27 Jun 2024.