Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting (TRUTH)

February 12, 2024 updated by: Central Finland Hospital District

Negative Pressure Wound Therapy Compared to Traditional Care After Split-thickness Skin Grafting - a Randomized Controlled Trial

The aim of this study is to compare negative pressure wound therapy to traditional care after split-thickness skin grafting in patients aged over 18.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not 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

Split-thickness skin grafting (STSG) is one of the most commonly used techniques in reconstructive plastic surgery and dermatology. Skin grafts are being used to cover skin defects caused by multiple etiologies. Traditionally, patients are immobilized in bed or in wheelchair for up to five days after surgery. Long immobilization decreases patients overall ability to function and increases the length of the stay in hospital. Negative pressure wound therapy (NPWT) have been used successfully in treatment of acute, chronic and diabetic ulcers. It is proposed that NPWT increases capillary blood flow, decreases bacterial contamination, seroma formation and swelling. Using NPWT on split-thickness skin grafts after burns is well documented. It increases skin graft take ratio and speeds up healing. Aim of this study is to compare NPWT to traditional treatment after STSG for any indication in patients aged 18 to 99. This is a two-arm, multicenter, randomized prospective trial with 160 patients.

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 (Estimated)

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.
160

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 Contact Backup

Study Locations

  • Finland
      • Jyväskylä, Finland, 40620
        • Central Finland Hospital
      • Tampere, Finland, 33521
        • Tampere University 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

Description

Inclusion Criteria:

  • Wound requiring skin graft surgery
  • Voluntary

Exclusion Criteria:

  • Not voluntary
  • Size of wound exceeding 15x15cm or 5x20cm
  • Previous skin graft operation to the same wound
  • Inability to co-operate
  • Wound depth over 1.5cm
  • Multiple wounds requiring skin grafting
  • Active infection in wound
  • Active osteomyelitis in region of wound
  • Flap reconstruction of the wound
  • Region of wound not suitable for negative pressure wound therapy (for example toes, foot sole)

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: Treatment
  • 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.
Experimental: Negative Pressure Wound Therapy
A negative pressure wound therapy device (PICO) is applied on split-thickness skin graft for 5 to 7 days from surgery in operating theatre. The patient can be mobilized immediately after skin graft procedure.
Device: Negative Pressure Wound Therapy
An immediate mobilization and negative pressure wound therapy (PICO) initiated after surgery.
Active Comparator: Conventional treatment
A conventional wound dressing is applied on wound in operating theatre, followed by immobilization for 5 days after split-thickness skin graft procedure.
Procedure: Conventional treatment
Traditional treatment with conventional wound dressing and 5 days of immobilization after surgery.

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
Between group difference in skin graft take
Time Frame: 2 weeks after surgery
Split-thickness skin graft take ratio (percentage of surface area)
2 weeks after surgery

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
Between group difference in skin graft take
Time Frame: 5 to 7 days after surgery
Split-thickness skin graft take ratio (percentage of surface area)
5 to 7 days after surgery
Between group difference in skin graft take
Time Frame: 8 weeks after surgery
Split-thickness skin graft take ratio (percentage of surface area)
8 weeks after surgery
Strength of pain (wound)
Time Frame: 5 to 7 days after surgery
Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain)
5 to 7 days after surgery
Strength of pain (wound)
Time Frame: 2 weeks
Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain)
2 weeks
Strength of pain (wound)
Time Frame: 8 weeks after surgery
Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain)
8 weeks after surgery
Strength of pain (wound)
Time Frame: 1 year after surgery
Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain)
1 year after surgery
Strength of pain (donor site)
Time Frame: 1 week after surgery
Strength of pain in skin graft donor site (Numeric rating scale 0 to 10; 0= no pain)
1 week after surgery
Strength of pain (donor site)
Time Frame: 2 weeks after surgery
Strength of pain in skin graft donor site (Numeric rating scale 0 to 10; 0= no pain)
2 weeks after surgery
Strength of pain (donor site)
Time Frame: 8 weeks after surgery
Strength of pain in skin graft donor site (Numeric rating scale 0 to 10; 0= no pain)
8 weeks after surgery
Strength of pain (donor site)
Time Frame: 1 year after surgery
Strength of pain in skin graft donor site (Numeric rating scale 0 to 10; 0= no pain)
1 year after surgery
POSAS score (wound)
Time Frame: 8 weeks after surgery
Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best) (wound)
8 weeks after surgery
POSAS score (wound)
Time Frame: 1 year after surgery
Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best)(wound)
1 year after surgery
POSAS score (donor site)
Time Frame: 8 weeks after surgery
Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best) (skin graft donor site)
8 weeks after surgery
POSAS score (donor site)
Time Frame: 1 year after surgery
Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best) (skin graft donor site)
1 year after surgery
Change in quality of life
Time Frame: 5 to7 days after surgery
Change in EuroQol Group 5-dimension self-report questionnaire (EQ-5D-5L) compared to baseline (before surgery)
5 to7 days after surgery
Change in quality of life
Time Frame: 2 weeks after surgery
Change in EuroQol Group 5-dimension self-report questionnaire (EQ-5D-5L) compared to baseline (before surgery)
2 weeks after surgery
Change in quality of life
Time Frame: 8 weeks after surgery
Change in EuroQol Group 5-dimension self-report questionnaire (EQ-5D-5L) compared to baseline (before surgery)
8 weeks after surgery
Change in quality of life
Time Frame: 1 year after surgery
Change in EuroQol Group 5-dimension self-report questionnaire (EQ-5D-5L) compared to baseline (before surgery)
1 year after surgery
Overall satisfaction
Time Frame: 5 to 7 days after surgery
Overall satisfaction with treatment (Likert)
5 to 7 days after surgery
Overall satisfaction
Time Frame: 2 weeks after surgery
Overall satisfaction with treatment (Likert)
2 weeks after surgery
Overall satisfaction
Time Frame: 8 weeks after surgery
Overall satisfaction with treatment (Likert)
8 weeks after surgery
Overall satisfaction
Time Frame: 1 year after surgery
Overall satisfaction with treatment (Likert)
1 year after surgery
Strength of itching (wound)
Time Frame: 5 to 7 days after surgery
Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching)
5 to 7 days after surgery
Strength of itching (wound)
Time Frame: 2 weeks after surgery
Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching)
2 weeks after surgery
Strength of itching (wound)
Time Frame: 8 weeks after surgery
Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching)
8 weeks after surgery
Strength of itching (wound)
Time Frame: 1 year after surgery
Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching)
1 year after surgery
Strength of itching (donor site)
Time Frame: 5 to 7 days after surgery
Strength of itching in skin graft donor site (Numeric rating scale 0 to 10, 0= no itching)
5 to 7 days after surgery
Strength of itching (donor site)
Time Frame: 2 weeks after surgery
Strength of itching in skin graft donor site (Numeric rating scale 0 to 10, 0= no itching)
2 weeks after surgery
Strength of itching (donor site)
Time Frame: 8 weeks after surgery
Strength of itching in skin graft donor site (Numeric rating scale 0 to 10, 0= no itching)
8 weeks after surgery
Strength of itching (donor site)
Time Frame: 1 year after surgery
Strength of itching in skin graft donor site (Numeric rating scale 0 to 10, 0= no itching)
1 year after surgery
Length of stay
Time Frame: Until 8 weeks after surgery
Length of hospital ward stay due to wound treatment (days)
Until 8 weeks after surgery
Number of visits
Time Frame: Until 8 weeks after surgery
Number of visits to hospital due to wound treatment
Until 8 weeks after surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Contamination
Time Frame: Immediately before skin graft procedure and antimicrobial prophylaxis
Type of bacterial flora in wound
Immediately before skin graft procedure and antimicrobial prophylaxis
Contamination
Time Frame: After revision during skin graft procedure
Type of bacterial flora in wound
After revision during skin graft procedure
Contamination
Time Frame: 5 to 7 days after skin graft procedure
Type of bacterial flora in wound
5 to 7 days after skin graft procedure

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.
Central Finland Hospital District

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.
University of Eastern Finland
Tampere University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Juha Paloneva, professor, Chief medical director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
September 19, 2018

Primary Completion (Estimated)

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.
December 31, 2024

Study Completion (Estimated)

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.
December 31, 2025

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).
August 24, 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.
August 24, 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.
August 28, 2018

Study Record Updates

Last Update Posted (Estimated)

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 13, 2024

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 12, 2024

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, 2024

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.
  • 6U/2018

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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