Incisional HerniaPICONCT03576222
Preventive PICO on Surgical Wounds After Large Incisional Hernia Repair
A study testing PICO DRESSING and MEPORE dressing in people with Incisional Hernia, run by Hospital Universitario La Fe at 1 site in Spain.
Trial summary
To determine the efficacy on decreasing the rate of surgical wound complications in patients undergoing repair of large incisional hernias, after the prophylactic application of a single-use negative pressure therapy dressing (PICO), versus a conventional dressing. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- PICO DRESSING and MEPORE dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2017to 25 Mar 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over 18 years old (men and women).
- To give his consent to participation in the study.
- To have surgical prosthetic repair of large incisional hernia (type W2 or W3).
- Patients admitted to the 6th floor, G tower (Unit of Abdominal Wall surgery).
Who cannot join
- Patients with immediate reintervention of abdominal surgery (less than 30 days from the first surgery).
- Patients after emergency surgery.
- Patients with biological prosthesis.
- Pregnancy and lactation.
- Hepatic cirrhosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized, Comparative Study About Effects of Preventive Negative Pressure Therapy With PICO or Standard Care Dressing (MEPORE) on Surgical Wounds After Large Incisional Hernia Repair
To determine the efficacy on decreasing the rate of surgical wound complications in patients undergoing repair of large incisional hernias, after the prophylactic application of a single-use negative pressure therapy dressing (PICO), versus a conventional dressing.
Read the detailed description
Hypothesis The preventive use of single-use PICO dressing reduces the complications of the surgical wound (infection and dehiscence of the surgical wound) in patients after large incisional hernia repair.
Objectives
Primary:
To determine the efficacy on decreasing the rate of surgical wound complications in patients undergoing eventration surgery, after the prophylactic application of a single-use negative pressure therapy (NPT) dressing, as opposed to a conventional dressing.
Secondary:
- To report the incidence of wound infection and dehiscence during the patient's admission, at 7 days, 15 days and month after surgical repair applying a conventional dressing (MEPORE) or PICO dressing.
- To quantify economic costs applying a PICO dressing versus a MEPORE dressing.
Methods:
Selection of patients Collection of the sample will be made in the Abdominal Wall Surgery Unit (La Fe Hospital), according to the inclusion and exclusion criteria. The surgeon will explain to the patient the objectives of the study and will give him an informed consent and will answer all the doubts about the study.
Patients will be assigned to two groups in a 1: 1 ratio. Assignment of each patient to the different groups will be done using a randomized method according to the following distribution:
- Group A, it will be applied the dressing object of study (PICO)
- Group B, it will be applied the conventional dressing (MEPORE).
Data collection and Study variables
For each patient, the data collection notebook designed for this purpose must be completed, which includes the following study variables:
- Dependent (study outcomes)
- Infection and dehiscence of surgical wound. These variables will be assessed throughout the admission and at 7 and 30 days from the hernia repair, during hospital stay, and at 15 days in the Unit.
- Variables related to direct costs (hospital stay, material, antibiotic use, operating room use, etc). Other variables related to indirect costs (time of cure by nursing).
- Independent
- Demographic data: age, sex, BMI.
- Classification ASA (American Society of Anesthesiologists)
- Risk factors abour surgical wound complications: drainage, preoperative chemotherapy, preoperative radiotherapy, Diabetes Mellitus, cardiovascular disease, immunosuppressive treatment, active smoking, obesity, hypertension, inflammatory bowel disease.
Number of subjects 150 patients undergoing hernia repair of large incisional hernia (types W2 or W3 according to EHS classification) will be included in La Fe Hospital in Valencia from January 2017 until the recruitment of the entire sample (estimated in December 2018).
- Conditions
- Incisional Hernia
- Being tested
- PICO DRESSING, MEPORE dressing
- Keywords
- PICO; incisional hernia; surgical site occurrences
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICO DRESSINGDevice
USE PICO DRESSING ON SURGICAL INCISION AFTER ABDOMINAL WALL REPAIR IN THE SURGICAL ROOM
MEPORE dressingDevice
MEPORE dressing
| Study group | Role | What they receive |
|---|---|---|
| patients with preventive PICO | Active comparator | PICO dressing is used in patients with incisional hernia intraoperatively Receives: Device: PICO DRESSING |
| patients with preventive MEPORE | Placebo comparator | MEPORE dressing is used in patients with incisional hernia intraoperatively Receives: Device: MEPORE dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
questionnaire
data about surgical site occurrences
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start1 May 2017
- Primary completion1 Jun 2018
- Study completion25 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Incisional HerniaStudies 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
- PICO dressing prevents surgical site ocurrences after abdominal Wall repair
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JOSE BUENO-LLEDÓ, Hospital Universitario La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03576222
- Sponsor's protocol ID
- PICO-01
- Acronym
- PICO
- Status last verified
- Mar 2020
- First submitted
- 9 Jun 2018
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gomoll AH, Lin A, Harris MB. Incisional vacuum-assisted closure therapy. J Orthop Trauma. 2006 Nov-Dec;20(10):705-9. doi: 10.1097/01.bot.0000211159.98239.d2.
PubMed 17106382Stannard JP, Zane Atkins B, O'Malley D, Singh H, Bernstein B, Fahey M, Masden D, Attinger CE. use of negative pressure therapy on closed surgical incisions: a case series. Wounds. 2009 Aug;21(8):221-8.
PubMed 25903674Arroyo AA, Casanova PL, Soriano JV, Torra I Bou JE. Open-label clinical trial comparing the clinical and economic effectiveness of using a polyurethane film surgical dressing with gauze surgical dressings in the care of post-operative surgical wounds. Int Wound J. 2015 Jun;12(3):285-92. doi: 10.1111/iwj.12099. Epub 2013 Jun 7.
PubMed 23742125Colli A, Camara ML. First experience with a new negative pressure incision management system on surgical incisions after cardiac surgery in high risk patients. J Cardiothorac Surg. 2011 Dec 6;6:160. doi: 10.1186/1749-8090-6-160.
PubMed 22145641Pellino G, Sciaudone G, Candilio G, Campitiello F, Selvaggi F, Canonico S. Effects of a new pocket device for negative pressure wound therapy on surgical wounds of patients affected with Crohn's disease: a pilot trial. Surg Innov. 2014 Apr;21(2):204-12. doi: 10.1177/1553350613496906. Epub 2013 Jul 24.
PubMed 23883481de Tullio D, Biondin V, Occhionorelli S. When a postsurgical dehiscence becomes a serious problem. Adv Skin Wound Care. 2011 Nov;24(11):503-6. doi: 10.1097/01.ASW.0000407646.05209.e2.
PubMed 22015748Ingargiola MJ, Daniali LN, Lee ES. Does the application of incisional negative pressure therapy to high-risk wounds prevent surgical site complications? A systematic review. Eplasty. 2013 Sep 20;13:e49. eCollection 2013.
PubMed 24106562Wilkes RP, Kilpad DV, Zhao Y, Kazala R, McNulty A. Closed incision management with negative pressure wound therapy (CIM): biomechanics. Surg Innov. 2012 Mar;19(1):67-75. doi: 10.1177/1553350611414920. Epub 2011 Aug 25.
PubMed 21868417Atkins BZ, Wooten MK, Kistler J, Hurley K, Hughes GC, Wolfe WG. Does negative pressure wound therapy have a role in preventing poststernotomy wound complications? Surg Innov. 2009 Jun;16(2):140-6. doi: 10.1177/1553350609334821. Epub 2009 May 21.
PubMed 19460818Cima R, Dankbar E, Lovely J, Pendlimari R, Aronhalt K, Nehring S, Hyke R, Tyndale D, Rogers J, Quast L; Colorectal Surgical Site Infection Reduction Team. Colorectal surgery surgical site infection reduction program: a national surgical quality improvement program--driven multidisciplinary single-institution experience. J Am Coll Surg. 2013 Jan;216(1):23-33. doi: 10.1016/j.jamcollsurg.2012.09.009. Epub 2012 Nov 2.
PubMed 23127793Anderson DJ, Kaye KS, Classen D, Arias KM, Podgorny K, Burstin H, Calfee DP, Coffin SE, Dubberke ER, Fraser V, Gerding DN, Griffin FA, Gross P, Klompas M, Lo E, Marschall J, Mermel LA, Nicolle L, Pegues DA, Perl TM, Saint S, Salgado CD, Weinstein RA, Wise R, Yokoe DS. Strategies to prevent surgical site infections in acute care hospitals. Infect Control Hosp Epidemiol. 2008 Oct;29 Suppl 1:S51-61. doi: 10.1086/591064. No abstract available.
PubMed 18840089Bueno-Lledo J, Franco-Bernal A, Garcia-Voz-Mediano MT, Torregrosa-Gallud A, Bonafe S. Prophylactic Single-use Negative Pressure Dressing in Closed Surgical Wounds After Incisional Hernia Repair: A Randomized, Controlled Trial. Ann Surg. 2021 Jun 1;273(6):1081-1086. doi: 10.1097/SLA.0000000000004310.
PubMed 33201116
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Comparative Study About Effects of Preventive Negative Pressure Therapy With PICO or Standard Care Dressing (MEPORE) on Surgical Wounds After Large Incisional Hernia Repair
- ClinicalTrials.gov ID
- NCT03576222
- Acronym / sponsor ID
- PICO / PICO-01
- Conditions
- Incisional Hernia
- Keywords
- PICO; incisional hernia; surgical site occurrences
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Hospital Universitario La FeUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 3 Jul 2018 (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.
To determine the efficacy on decreasing the rate of surgical wound complications in patients undergoing repair of large incisional hernias, after the prophylactic application of a single-use negative pressure therapy dressing (PICO), versus a conventional dressing.
Detailed description
Hypothesis The preventive use of single-use PICO dressing reduces the complications of the surgical wound (infection and dehiscence of the surgical wound) in patients after large incisional hernia repair.
Objectives
Primary:
To determine the efficacy on decreasing the rate of surgical wound complications in patients undergoing eventration surgery, after the prophylactic application of a single-use negative pressure therapy (NPT) dressing, as opposed to a conventional dressing.
Secondary:
- To report the incidence of wound infection and dehiscence during the patient's admission, at 7 days, 15 days and month after surgical repair applying a conventional dressing (MEPORE) or PICO dressing.
- To quantify economic costs applying a PICO dressing versus a MEPORE dressing.
Methods:
Selection of patients Collection of the sample will be made in the Abdominal Wall Surgery Unit (La Fe Hospital), according to the inclusion and exclusion criteria. The surgeon will explain to the patient the objectives of the study and will give him an informed consent and will answer all the doubts about the study.
Patients will be assigned to two groups in a 1: 1 ratio. Assignment of each patient to the different groups will be done using a randomized method according to the following distribution:
- Group A, it will be applied the dressing object of study (PICO)
- Group B, it will be applied the conventional dressing (MEPORE).
Data collection and Study variables
For each patient, the data collection notebook designed for this purpose must be completed, which includes the following study variables:
- Dependent (study outcomes)
- Infection and dehiscence of surgical wound. These variables will be assessed throughout the admission and at 7 and 30 days from the hernia repair, during hospital stay, and at 15 days in the Unit.
- Variables related to direct costs (hospital stay, material, antibiotic use, operating room use, etc). Other variables related to indirect costs (time of cure by nursing).
- Independent
- Demographic data: age, sex, BMI.
- Classification ASA (American Society of Anesthesiologists)
- Risk factors abour surgical wound complications: drainage, preoperative chemotherapy, preoperative radiotherapy, Diabetes Mellitus, cardiovascular disease, immunosuppressive treatment, active smoking, obesity, hypertension, inflammatory bowel disease.
Number of subjects 150 patients undergoing hernia repair of large incisional hernia (types W2 or W3 according to EHS classification) will be included in La Fe Hospital in Valencia from January 2017 until the recruitment of the entire sample (estimated in December 2018).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- PICO dressing prevents surgical site ocurrences after abdominal Wall repair
| Arm | Type | Receives |
|---|---|---|
| patients with preventive PICO | Active comparator | Device: PICO DRESSINGPICO dressing is used in patients with incisional hernia intraoperatively |
| patients with preventive MEPORE | Placebo comparator | Device: MEPORE dressingMEPORE dressing is used in patients with incisional hernia intraoperatively |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over 18 years old (men and women).
- To give his consent to participation in the study.
- To have surgical prosthetic repair of large incisional hernia (type W2 or W3).
- Patients admitted to the 6th floor, G tower (Unit of Abdominal Wall surgery).
Key exclusion criteria (5 listed)
- Patients with immediate reintervention of abdominal surgery (less than 30 days from the first surgery).
- Patients after emergency surgery.
- Patients with biological prosthesis.
- Pregnancy and lactation.
- Hepatic cirrhosis.
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 |
|---|---|---|
| PICO DRESSINGUSE PICO DRESSING ON SURGICAL INCISION AFTER ABDOMINAL WALL REPAIR IN THE SURGICAL ROOM | Device | patients with preventive PICO |
| MEPORE dressingMEPORE dressing | Device | patients with preventive MEPORE |
Primary outcome
questionnaire
Time frame: 1 YEAR
data about surgical site occurrences
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 31 Mar 2020.
- Results publication: PubMed 17106382Gomoll AH, Lin A, Harris MB. Incisional vacuum-assisted closure therapy. J Orthop Trauma. 2006 Nov-Dec;20(10):705-9. doi: 10.1097/01.bot.0000211159.98239.d2.
- Results publication: PubMed 25903674Stannard JP, Zane Atkins B, O'Malley D, Singh H, Bernstein B, Fahey M, Masden D, Attinger CE. use of negative pressure therapy on closed surgical incisions: a case series. Wounds. 2009 Aug;21(8):221-8.
- Results publication: PubMed 23742125Arroyo AA, Casanova PL, Soriano JV, Torra I Bou JE. Open-label clinical trial comparing the clinical and economic effectiveness of using a polyurethane film surgical dressing with gauze surgical dressings in the care of post-operative surgical wounds. Int Wound J. 2015 Jun;12(3):285-92. doi: 10.1111/iwj.12099. Epub 2013 Jun 7.
- Results publication: PubMed 22145641Colli A, Camara ML. First experience with a new negative pressure incision management system on surgical incisions after cardiac surgery in high risk patients. J Cardiothorac Surg. 2011 Dec 6;6:160. doi: 10.1186/1749-8090-6-160.
- Results publication: PubMed 23883481Pellino G, Sciaudone G, Candilio G, Campitiello F, Selvaggi F, Canonico S. Effects of a new pocket device for negative pressure wound therapy on surgical wounds of patients affected with Crohn's disease: a pilot trial. Surg Innov. 2014 Apr;21(2):204-12. doi: 10.1177/1553350613496906. Epub 2013 Jul 24.
- Results publication: PubMed 22015748de Tullio D, Biondin V, Occhionorelli S. When a postsurgical dehiscence becomes a serious problem. Adv Skin Wound Care. 2011 Nov;24(11):503-6. doi: 10.1097/01.ASW.0000407646.05209.e2.
- Results publication: PubMed 24106562Ingargiola MJ, Daniali LN, Lee ES. Does the application of incisional negative pressure therapy to high-risk wounds prevent surgical site complications? A systematic review. Eplasty. 2013 Sep 20;13:e49. eCollection 2013.
- Results publication: PubMed 21868417Wilkes RP, Kilpad DV, Zhao Y, Kazala R, McNulty A. Closed incision management with negative pressure wound therapy (CIM): biomechanics. Surg Innov. 2012 Mar;19(1):67-75. doi: 10.1177/1553350611414920. Epub 2011 Aug 25.
- Results publication: PubMed 19460818Atkins BZ, Wooten MK, Kistler J, Hurley K, Hughes GC, Wolfe WG. Does negative pressure wound therapy have a role in preventing poststernotomy wound complications? Surg Innov. 2009 Jun;16(2):140-6. doi: 10.1177/1553350609334821. Epub 2009 May 21.
- Results publication: PubMed 23127793Cima R, Dankbar E, Lovely J, Pendlimari R, Aronhalt K, Nehring S, Hyke R, Tyndale D, Rogers J, Quast L; Colorectal Surgical Site Infection Reduction Team. Colorectal surgery surgical site infection reduction program: a national surgical quality improvement program--driven multidisciplinary single-institution experience. J Am Coll Surg. 2013 Jan;216(1):23-33. doi: 10.1016/j.jamcollsurg.2012.09.009. Epub 2012 Nov 2.
- Results publication: PubMed 18840089Anderson DJ, Kaye KS, Classen D, Arias KM, Podgorny K, Burstin H, Calfee DP, Coffin SE, Dubberke ER, Fraser V, Gerding DN, Griffin FA, Gross P, Klompas M, Lo E, Marschall J, Mermel LA, Nicolle L, Pegues DA, Perl TM, Saint S, Salgado CD, Weinstein RA, Wise R, Yokoe DS. Strategies to prevent surgical site infections in acute care hospitals. Infect Control Hosp Epidemiol. 2008 Oct;29 Suppl 1:S51-61. doi: 10.1086/591064. No abstract available.
- Derived from this study: PubMed 33201116Bueno-Lledo J, Franco-Bernal A, Garcia-Voz-Mediano MT, Torregrosa-Gallud A, Bonafe S. Prophylactic Single-use Negative Pressure Dressing in Closed Surgical Wounds After Incisional Hernia Repair: A Randomized, Controlled Trial. Ann Surg. 2021 Jun 1;273(6):1081-1086. doi: 10.1097/SLA.0000000000004310.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICO DRESSING and MEPORE dressing in people with Incisional Hernia, run by Hospital Universitario La Fe at 1 site in Spain.
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 4 inclusion and 5 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 31 Mar 2020. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
questionnaire (time frame: 1 YEAR). 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 NCT03576222, which also lists 12 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 31 Mar 2020.