Negative Pressure Wound Therapy for Wound Healing After Stoma Reversal (NESTOR)

February 2, 2021 updated by: Istituto Clinico Humanitas

Efficacy of Negative Pressure Wound Therapy (NPWT) for Prevention of Wound Infection and Improvement of Wound Healing After Stoma Reversal

Stoma reversal is associated with high incidence of post-surgical complications, including Surgical Site Infections (SSI). Negative Pressure Wound Therapy (NPWT) has been successfully applied to surgical wound management, reducing the SSIs incidence. This is a randomized open-label trial to assess the efficacy of NPWT in decreasing the rate of SSI after stoma reversal.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Stoma reversal after abdominal resection is associated with several complications, of which the most common is wound infection. Surgical Site Infections (SSI) usually result in increased long-term complications, such as incisional hernia, prolonged hospital stay, increased outpatients visits and medical costs. Negative-Pressure-Wound-Therapy (NPWT) is a technique using vacuum dressing, commonly used to promote surgical wound healing, but there is a significant lack of knowledge about its safety and efficacy in promoting wound healing after stoma closure. This is an interventional, randomized, open label trial to evaluate the safety and efficacy of the NPWT (PICO™ system, Smith&Nephew Healthcare, Hull, UK) on stoma wound compared to Standard of Care (SOC).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
    • MI
      • Rozzano, MI, Italy, 20089
        • Recruiting
        • HUMANITAS Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >18 years, any sex;
  • Patients who underwent elective open or laparoscopic rectal resection ostomy construction (loop/end ileostomy; loop/end colostomy) for either oncological and Inflammatory Bowel Disease (IBD) indications;
  • Normal water contrast enema prior to surgery;
  • Both neo-adjuvant and adjuvant treatment are allowed for cancer patients;
  • Both immunosuppressant and biological medications are allowed for IBD patients.

Exclusion Criteria:

  • Patients age at screening < 18 years;
  • Pregnant or breastfeeding women;
  • Neurodegenerative disorders or psychiatric diseases;
  • Contraindications or hypersensitivity to the use of the investigational product or its components;
  • Patients with skin features (e.g., tattoos, pre-existing scarring) which could interfere with the study assessments;
  • Patients with post-operative bleeding (to be assessed 24 hours after surgery).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard of Care (SOC)
After stoma reversal, patients of SOC group will be treated as for normal clinical practice, using a simple adhesive wound dressing.
Experimental: Negative Pressure Wound Therapy (NPWT)
PICO™ 7 will be applied after stoma reversal
Device: PICO™ 7
PICO™ system (Smith&Nephew Healthcare, Hull, UK) is a Single-Use Negative Pressure Wound Therapy (NPWT) System consisting of a small portable pump, 2 lithium batteries, 2 dressings and fixation strips.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Surgical Site Infection (SSI) rate comparison
Time Frame: Post-operative day 7
The rate of superficial (infections involving only the skin and subcutaneous tissue) or deep (infections involving the muscle and the fascia but not organ space) SSI will be assessed by medical examination
Post-operative day 7
Surgical Site Infection (SSI) rate comparison
Time Frame: Post-operative day 30
The rate of superficial (infections involving only the skin and subcutaneous tissue) or deep (infections involving the muscle and the fascia but not organ space) SSI will be assessed by medical examination
Post-operative day 30

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Wound healing timing comparison
Time Frame: Post-operative day 30
Wound healing is defined as complete tissue restoration, scar formation and absence of resected tissues and will be assessed by medical examination
Post-operative day 30
Quality of life assessment
Time Frame: Post-operative day 7
Quality of life will be assessed using the EuroQol-5 Dimension-5 Levels (EQ5D5L) questionnaire. The EQ5D5L questionnaire comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The questionnaire also includes a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.
Post-operative day 7
Quality of life assessment
Time Frame: Post-operative day 30
Quality of life will be assessed using the EuroQol-5 Dimension-5 Levels (EQ5D5L) questionnaire. The EQ5D5L questionnaire comprises 5 dimensions (mobility, self) care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The questionnaire also includes a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.
Post-operative day 30
Quality of life assessment
Time Frame: Post-operative day 90
Quality of life will be assessed using the EuroQol-5 Dimension-5 Levels (EQ5D5L) questionnaire. The EQ5D5L questionnaire comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The questionnaire also includes a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.
Post-operative day 90
Quality of life assessment
Time Frame: Post-operative day 180
Quality of life will be assessed using the EuroQol-5 Dimension-5 Levels (EQ5D5L) questionnaire. The EQ5D5L questionnaire comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The questionnaire also includes a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.
Post-operative day 180
Pain assessment
Time Frame: Post-operative day 7
Pain will be measured using the McGill Pain questionnaire. The questionnaire presents a list of 78 words in 20 sections that are related to pain. The users mark the words that best describe their pain (multiple markings are allowed). Among the words, sections of these words signify different components of pain: Sensory (sections 1-10), Affective (sections 11-15), Evaluative (section 16), and Miscellaneous (sections 17-20).
Post-operative day 7
Pain assessment
Time Frame: Post-operative day 30
Pain will be measured using the McGill Pain questionnaire. The questionnaire presents a list of 78 words in 20 sections that are related to pain. The users mark the words that best describe their pain (multiple markings are allowed). Among the words, sections of these words signify different components of pain: Sensory (sections 1-10), Affective (sections 11-15), Evaluative (section 16), and Miscellaneous (sections 17-20).
Post-operative day 30
Pain assessment
Time Frame: Post-operative day 90
Pain will be measured using the McGill Pain questionnaire. The questionnaire presents a list of 78 words in 20 sections that are related to pain. The users mark the words that best describe their pain (multiple markings are allowed). Among the words, sections of these words signify different components of pain: Sensory (sections 1-10), Affective (sections 11-15), Evaluative (section 16), and Miscellaneous (sections 17-20).
Post-operative day 90
Pain assessment
Time Frame: Post-operative day 180
Pain will be measured using the McGill Pain questionnaire. The questionnaire presents a list of 78 words in 20 sections that are related to pain. The users mark the words that best describe their pain (multiple markings are allowed). Among the words, sections of these words signify different components of pain: Sensory (sections 1-10), Affective (sections 11-15), Evaluative (section 16), and Miscellaneous (sections 17-20).
Post-operative day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Clinico Humanitas

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Smith & Nephew, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 18, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 824

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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