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

Primary Purpose

Wound of Skin, Wound Heal, Wound

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Negative Pressure Wound Therapy
Conventional treatment
Sponsored by
Central Finland Hospital District
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound of Skin focused on measuring Negative pressure wound therapy, Skin graft, split-thickness skin graft

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Central Finland HospitalRecruiting
  • Tampere University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Negative Pressure Wound Therapy

Conventional treatment

Arm Description

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.

A conventional wound dressing is applied on wound in operating theatre, followed by immobilization for 5 days after split-thickness skin graft procedure.

Outcomes

Primary Outcome Measures

Between group difference in skin graft take
Split-thickness skin graft take ratio (percentage of surface area)

Secondary Outcome Measures

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

Full Information

First Posted
August 24, 2018
Last Updated
March 2, 2023
Sponsor
Central Finland Hospital District
Collaborators
Tampere University Hospital, University of Eastern Finland
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1. Study Identification

Unique Protocol Identification Number
NCT03649308
Brief Title
Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting
Acronym
TRUTH
Official Title
Negative Pressure Wound Therapy Compared to Traditional Care After Split-thickness Skin Grafting - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Finland Hospital District
Collaborators
Tampere University Hospital, University of Eastern Finland

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound of Skin, Wound Heal, Wound, Wound Open, Wound Breakdown, Skin Wound, Skin Scarring
Keywords
Negative pressure wound therapy, Skin graft, split-thickness skin graft

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
After split-thickness skin graft procedure, the participants are assigned to either conventional treatment or negative pressure wound therapy group in parallel for the duration of the study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Negative Pressure Wound Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional treatment
Arm Type
Active Comparator
Arm Description
A conventional wound dressing is applied on wound in operating theatre, followed by immobilization for 5 days after split-thickness skin graft procedure.
Intervention Type
Device
Intervention Name(s)
Negative Pressure Wound Therapy
Intervention Description
An immediate mobilization and negative pressure wound therapy (PICO) initiated after surgery.
Intervention Type
Procedure
Intervention Name(s)
Conventional treatment
Intervention Description
Traditional treatment with conventional wound dressing and 5 days of immobilization after surgery.
Primary Outcome Measure Information:
Title
Between group difference in skin graft take
Description
Split-thickness skin graft take ratio (percentage of surface area)
Time Frame
2 weeks after surgery
Secondary Outcome Measure Information:
Title
Between group difference in skin graft take
Description
Split-thickness skin graft take ratio (percentage of surface area)
Time Frame
5 to 7 days after surgery
Title
Between group difference in skin graft take
Description
Split-thickness skin graft take ratio (percentage of surface area)
Time Frame
8 weeks after surgery
Title
Strength of pain (wound)
Description
Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain)
Time Frame
5 to 7 days after surgery
Title
Strength of pain (wound)
Description
Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain)
Time Frame
2 weeks
Title
Strength of pain (wound)
Description
Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain)
Time Frame
8 weeks after surgery
Title
Strength of pain (wound)
Description
Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain)
Time Frame
1 year after surgery
Title
Strength of pain (donor site)
Description
Strength of pain in skin graft donor site (Numeric rating scale 0 to 10; 0= no pain)
Time Frame
1 week after surgery
Title
Strength of pain (donor site)
Description
Strength of pain in skin graft donor site (Numeric rating scale 0 to 10; 0= no pain)
Time Frame
2 weeks after surgery
Title
Strength of pain (donor site)
Description
Strength of pain in skin graft donor site (Numeric rating scale 0 to 10; 0= no pain)
Time Frame
8 weeks after surgery
Title
Strength of pain (donor site)
Description
Strength of pain in skin graft donor site (Numeric rating scale 0 to 10; 0= no pain)
Time Frame
1 year after surgery
Title
POSAS score (wound)
Description
Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best) (wound)
Time Frame
8 weeks after surgery
Title
POSAS score (wound)
Description
Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best)(wound)
Time Frame
1 year after surgery
Title
POSAS score (donor site)
Description
Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best) (skin graft donor site)
Time Frame
8 weeks after surgery
Title
POSAS score (donor site)
Description
Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best) (skin graft donor site)
Time Frame
1 year after surgery
Title
Change in quality of life
Description
Change in EuroQol Group 5-dimension self-report questionnaire (EQ-5D-5L) compared to baseline (before surgery)
Time Frame
5 to7 days after surgery
Title
Change in quality of life
Description
Change in EuroQol Group 5-dimension self-report questionnaire (EQ-5D-5L) compared to baseline (before surgery)
Time Frame
2 weeks after surgery
Title
Change in quality of life
Description
Change in EuroQol Group 5-dimension self-report questionnaire (EQ-5D-5L) compared to baseline (before surgery)
Time Frame
8 weeks after surgery
Title
Change in quality of life
Description
Change in EuroQol Group 5-dimension self-report questionnaire (EQ-5D-5L) compared to baseline (before surgery)
Time Frame
1 year after surgery
Title
Overall satisfaction
Description
Overall satisfaction with treatment (Likert)
Time Frame
5 to 7 days after surgery
Title
Overall satisfaction
Description
Overall satisfaction with treatment (Likert)
Time Frame
2 weeks after surgery
Title
Overall satisfaction
Description
Overall satisfaction with treatment (Likert)
Time Frame
8 weeks after surgery
Title
Overall satisfaction
Description
Overall satisfaction with treatment (Likert)
Time Frame
1 year after surgery
Title
Strength of itching (wound)
Description
Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching)
Time Frame
5 to 7 days after surgery
Title
Strength of itching (wound)
Description
Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching)
Time Frame
2 weeks after surgery
Title
Strength of itching (wound)
Description
Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching)
Time Frame
8 weeks after surgery
Title
Strength of itching (wound)
Description
Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching)
Time Frame
1 year after surgery
Title
Strength of itching (donor site)
Description
Strength of itching in skin graft donor site (Numeric rating scale 0 to 10, 0= no itching)
Time Frame
5 to 7 days after surgery
Title
Strength of itching (donor site)
Description
Strength of itching in skin graft donor site (Numeric rating scale 0 to 10, 0= no itching)
Time Frame
2 weeks after surgery
Title
Strength of itching (donor site)
Description
Strength of itching in skin graft donor site (Numeric rating scale 0 to 10, 0= no itching)
Time Frame
8 weeks after surgery
Title
Strength of itching (donor site)
Description
Strength of itching in skin graft donor site (Numeric rating scale 0 to 10, 0= no itching)
Time Frame
1 year after surgery
Title
Length of stay
Description
Length of hospital ward stay due to wound treatment (days)
Time Frame
Until 8 weeks after surgery
Title
Number of visits
Description
Number of visits to hospital due to wound treatment
Time Frame
Until 8 weeks after surgery
Other Pre-specified Outcome Measures:
Title
Contamination
Description
Type of bacterial flora in wound
Time Frame
Immediately before skin graft procedure and antimicrobial prophylaxis
Title
Contamination
Description
Type of bacterial flora in wound
Time Frame
After revision during skin graft procedure
Title
Contamination
Description
Type of bacterial flora in wound
Time Frame
5 to 7 days after skin graft procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juha Paloneva, MD, PhD
Phone
+358 14 269 1811
Email
juha.paloneva@ksshp.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Kristiina Hietanen, MD
Phone
+358 14 269 1811
Email
kristiina.hietanen@ksshp.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juha Paloneva, professor
Organizational Affiliation
Chief medical director
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Finland Hospital
City
Jyväskylä
ZIP/Postal Code
40620
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juha Paloneva, MD, PhD
Phone
+358 14 2693119
First Name & Middle Initial & Last Name & Degree
Kristiina Hietanen, MD
Email
kristiina.hietanen@ksshp.fi
First Name & Middle Initial & Last Name & Degree
Juha Paloneva, MD, PhD
First Name & Middle Initial & Last Name & Degree
Kristiina Hietanen, MD
First Name & Middle Initial & Last Name & Degree
Jussi Repo, MD, PhD
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julianna Weitz, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26940940
Citation
Serra R, Rizzuto A, Rossi A, Perri P, Barbetta A, Abdalla K, Caroleo S, Longo C, Amantea B, Sammarco G, de Franciscis S. Skin grafting for the treatment of chronic leg ulcers - a systematic review in evidence-based medicine. Int Wound J. 2017 Feb;14(1):149-157. doi: 10.1111/iwj.12575. Epub 2016 Mar 4.
Results Reference
background
PubMed Identifier
24577227
Citation
Waltzman JT, Bell DE. Vacuum-assisted closure device as a split-thickness skin graft bolster in the burn population. J Burn Care Res. 2014 Sep-Oct;35(5):e338-42. doi: 10.1097/BCR.0000000000000009.
Results Reference
background
PubMed Identifier
20825510
Citation
Blume PA, Key JJ, Thakor P, Thakor S, Sumpio B. Retrospective evaluation of clinical outcomes in subjects with split-thickness skin graft: comparing V.A.C.(R) therapy and conventional therapy in foot and ankle reconstructive surgeries. Int Wound J. 2010 Dec;7(6):480-7. doi: 10.1111/j.1742-481X.2010.00728.x. Epub 2010 Sep 6.
Results Reference
background

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Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting

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