Stoma IleostomyNCT04088162
The Use of Post-operative NPWT Dressing in the Prevention of Infectious Complications After Ostomy Reversal Surgery
A study testing Postoperative Negative Pressure Wound Therapy KCI NANOVA in people with Stoma Ileostomy and Surgical Wound, run by Michał Pędziwiatr at 2 sites in Poland.
Trial summary
Introduction: Although negative-pressure wound therapy (NPWT) is likely advantageous for wound healing, the efficacy and safety of its prophylactic use remain unclear. We performed a Randomized Control Trial to assess the usefulness of postoperative NPWT in reduction of postoperative wound healing complications and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stoma Ileostomy, Surgical Wound, Negative Pressure Wound Therapy
- What is being tested?
- Postoperative Negative Pressure Wound Therapy KCI NANOVA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Jan 2016to 1 Jan 2021
- 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
- Patients aged 18 or older
- Previous colorectal resection with the formation of protective ileostomy due to cancer
- Ileostomy closure surgery as an elective procedure.
Who cannot join
- Emergency or urgent operation
- Active infection
- Other than ileostomy closure or parastomal hernioplasty operation performed.
- Patents who within 1 week after operation will be re-operated or transferred to Intensive Care Unit or other hospital word due to noninfectious complications
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
2nd Department of General Surgery, Jagiellonian University
Krakow, 31-501
Oddział kliniczny chirurgii ogólnej, endokrynologicznej i onkologii gastroenterologicznej
Poznan, Wielkopolska, 60-355
About this study
Official title: The Use of Post-operative Negative Pressure Wound Therapy (NPWT) Dressing in the Prevention of Wound Healing Problems and Infectious Complications After Ostomy Reversal Surgery.
Introduction: Although negative-pressure wound therapy (NPWT) is likely advantageous for wound healing, the efficacy and safety of its prophylactic use remain unclear. We performed a Randomized Control Trial to assess the usefulness of postoperative NPWT in reduction of postoperative wound healing complications and surgical site infections after diverting ileostomy closure, in the group of patients previously operated for colorectal resection due to cancer.
Materials \& Methods: Prospective, randomized study will be conducted. Patients with past history of colorectal cancer laparoscopic surgery with protective loop ileostomy scheduled to undergo ileostomy closure with primary wound closure will be randomly divided into groups with or without NPWT. The primary endpoint are incidence of wound related complications (WRC) (wound healing complications witch required surgical intervention other than suture removal or dressing changing). The secondary endpoints are incidences of Surgical Site Infection (SSI) and length of postoperative hospital stay (LOS) and length of complete wound healing (CWH). Cost analysis will also be performed.
In first step of this study between January 2016 and December 2018 we will asses the usefulness of one of the NPWT devices (NANOVA KCI) in prevention of WHC in established group. The second part of the study will be performed in 2 centers between January 2019 and December 2021. In this step we want to compere other NPWT devices in the same application and to confirm single center outcomes .
- Conditions
- Stoma Ileostomy, Surgical Wound, Negative Pressure Wound Therapy, Postoperative Wound Infection
- Being tested
- Postoperative Negative Pressure Wound Therapy KCI NANOVA
- Medical subject headings
- Surgical Wound, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative Negative Pressure Wound Therapy KCI NANOVADevice
Also called Postop. NPWT, Postoperative VAC
| Study group | Role | What they receive |
|---|---|---|
| Standard Dressing | No intervention | In case of Control group. After Ileostomy closure skin will be closed by 6 to 8 single no absorbable Monosyn 3-0 (Ethicon, Cincinnati, Ohio., USA) sutures, and sterile standard dressing will be placed. |
| Postoperative NPWT dressing | Experimental | In case of NPWT group. After Ileostomy closure skin will be closed by 3 or 4 single no absorbable Monosyn 3-0 (Ethicon, Cincinnati, Ohio., USA) sutures. Between them small sponge "tongues" 1x 0,5x2 cm were placed and over whole incision an NANOVA (KCI USA) negative pressure dressing will be placed. In control group first dressing change was made in 48 hours after operation and then every day until suture removal at 7 postoperative day. In NPWT group NANOVA dressing was taken out at 72 hours. 3 steri-streps were placed between sutures and standard sterile dressing was placed. After it dressing was changed every 24 hours until suture removal at 7 postoperative day. Receives: Device: Postoperative Negative Pressure Wound Therapy KCI NANOVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of wound management complications
Primary endpoint is described as a reduction of wound healing complications (WHC) after protective ostomy closure in a group of patients previously operated for colorectal cancer with protective ileostomy formation. Wound healing complications are described as any condition of wound which required postoperative intervention other than change of dressing or removing of sutures .
Measured: 90 days
Incidence of wound management complications in groups treated with different types of postopNPWT
The primary endpoint is described as a comparison of reduction of wound healing complications (WHC) after protective ostomy closure in a group of patients previously operated for colorectal cancer with protective ileostomy formation between 3 different postopNPWT devices (KCI NANOVA, Smith\&Naphiew PICO and Gynadyne XLR 8) . Wound healing complications are described as any condition of wound which required postoperative intervention other than change of dressing or removing of sutures .
Measured: 90 days
Secondary outcomes (3)
Surgical Site Infections (SSI) Incidence
Secondary endpoints is described as incidence of SSI. Incisional SSI diagnosis criteria included an infection that occurred within 30 days after the operation involving the skin, subcutaneous tissue, or deep soft tissue (e.g. fascia and muscle layers) at the incision site, organ or space according to the criteria of CDC and ECDC for diagnosis of SSI
Measured: 90 days
Postoperative Hospital Stay (LOS)
Secondary endpoints is described as postoperative length of hospital stay (LOS)
Measured: 90 days
Complete wound healing (CWH) time
Secondary endpoints is described as the duration of complete wound healing (CWH). Complete wound healing was defined as complete closure of the wound without any discharge at the outpatient clinic or reported by patient.
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start1 Jan 2016
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
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 Stoma IleostomyStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michał Pędziwiatr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michał Pędziwiatr, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088162
- Sponsor's protocol ID
- JagiellonianU-05
- Status last verified
- Sep 2019
- First submitted
- 31 Aug 2019
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wierdak M, Pisarska-Adamczyk M, Wysocki M, Major P, Kolodziejska K, Nowakowski M, Vongsurbchart T, Pedziwiatr M. Prophylactic negative-pressure wound therapy after ileostomy reversal for the prevention of wound healing complications in colorectal cancer patients: a randomized controlled trial. Tech Coloproctol. 2021 Feb;25(2):185-193. doi: 10.1007/s10151-020-02372-w. Epub 2020 Nov 7.
PubMed 33161523
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Post-operative Negative Pressure Wound Therapy (NPWT) Dressing in the Prevention of Wound Healing Problems and Infectious Complications After Ostomy Reversal Surgery.
- ClinicalTrials.gov ID
- NCT04088162
- Acronym / sponsor ID
- JagiellonianU-05
- Conditions
- Stoma Ileostomy, Surgical Wound, Negative Pressure Wound Therapy, Postoperative Wound Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Michał PędziwiatrUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 12 Sep 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.
Introduction: Although negative-pressure wound therapy (NPWT) is likely advantageous for wound healing, the efficacy and safety of its prophylactic use remain unclear. We performed a Randomized Control Trial to assess the usefulness of postoperative NPWT in reduction of postoperative wound healing complications and surgical site infections after diverting ileostomy closure, in the group of patients previously operated for colorectal resection due to cancer.
Materials \& Methods: Prospective, randomized study will be conducted. Patients with past history of colorectal cancer laparoscopic surgery with protective loop ileostomy scheduled to undergo ileostomy closure with primary wound closure will be randomly divided into groups with or without NPWT. The primary endpoint are incidence of wound related complications (WRC) (wound healing complications witch required surgical intervention other than suture removal or dressing changing). The secondary endpoints are incidences of Surgical Site Infection (SSI) and length of postoperative hospital stay (LOS) and length of complete wound healing (CWH). Cost analysis will also be performed.
In first step of this study between January 2016 and December 2018 we will asses the usefulness of one of the NPWT devices (NANOVA KCI) in prevention of WHC in established group. The second part of the study will be performed in 2 centers between January 2019 and December 2021. In this step we want to compere other NPWT devices in the same application and to confirm single center outcomes .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Dressing | No intervention | –In case of Control group. After Ileostomy closure skin will be closed by 6 to 8 single no absorbable Monosyn 3-0 (Ethicon, Cincinnati, Ohio., USA) sutures, and sterile standard dressing will be placed. |
| Postoperative NPWT dressing | Experimental | Device: Postoperative Negative Pressure Wound Therapy KCI NANOVAIn case of NPWT group. After Ileostomy closure skin will be closed by 3 or 4 single no absorbable Monosyn 3-0 (Ethicon, Cincinnati, Ohio., USA) sutures. Between them small sponge "tongues" 1x 0,5x2 cm were placed and over whole incision an NANOVA (KCI USA) negative pressure dressing will be placed. In control group first dressing change was made in 48 hours after operation and then every day until suture removal at 7 postoperative day. In NPWT group NANOVA dressing was taken out at 72 hours. 3 steri-streps were placed between sutures and standard sterile dressing was placed. After it dressing was changed every 24 hours until suture removal at 7 postoperative day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 or older
- Previous colorectal resection with the formation of protective ileostomy due to cancer
- Ileostomy closure surgery as an elective procedure.
Key exclusion criteria (4 listed)
- Emergency or urgent operation
- Active infection
- Other than ileostomy closure or parastomal hernioplasty operation performed.
- Patents who within 1 week after operation will be re-operated or transferred to Intensive Care Unit or other hospital word due to noninfectious complications
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 |
|---|---|---|
| Postoperative Negative Pressure Wound Therapy KCI NANOVAAlso: Postop. NPWT, Postoperative VAC | Device | Postoperative NPWT dressing |
Primary outcome
Incidence of wound management complications
Time frame: 90 days
Primary endpoint is described as a reduction of wound healing complications (WHC) after protective ostomy closure in a group of patients previously operated for colorectal cancer with protective ileostomy formation. Wound healing complications are described as any condition of wound which required postoperative intervention other than change of dressing or removing of sutures .
Incidence of wound management complications in groups treated with different types of postopNPWT
Time frame: 90 days
The primary endpoint is described as a comparison of reduction of wound healing complications (WHC) after protective ostomy closure in a group of patients previously operated for colorectal cancer with protective ileostomy formation between 3 different postopNPWT devices (KCI NANOVA, Smith\&Naphiew PICO and Gynadyne XLR 8) . Wound healing complications are described as any condition of wound which required postoperative intervention other than change of dressing or removing of sutures .
3 secondary outcomes
Surgical Site Infections (SSI) Incidence
Time frame: 90 days
Postoperative Hospital Stay (LOS)
Time frame: 90 days
Complete wound healing (CWH) time
Time frame: 90 Days
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 20 Mar 2024.
- Derived from this study: PubMed 33161523Wierdak M, Pisarska-Adamczyk M, Wysocki M, Major P, Kolodziejska K, Nowakowski M, Vongsurbchart T, Pedziwiatr M. Prophylactic negative-pressure wound therapy after ileostomy reversal for the prevention of wound healing complications in colorectal cancer patients: a randomized controlled trial. Tech Coloproctol. 2021 Feb;25(2):185-193. doi: 10.1007/s10151-020-02372-w. Epub 2020 Nov 7.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative Negative Pressure Wound Therapy KCI NANOVA in people with Stoma Ileostomy and Surgical Wound, run by Michał Pędziwiatr at 2 sites in Poland.
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 4 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 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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?
Incidence of wound management complications (time frame: 90 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 NCT04088162, 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 20 Mar 2024.