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

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: Active, not recruiting
• Conditions: Wound Heal; Wound; Skin Wound; Skin Scarring; Wound of Skin; Wound Open; Wound Breakdown
• Intervention / Treatment: Device: Negative Pressure Wound Therapy; Procedure: Conventional treatment

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: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contamination	Type of bacterial flora in wound	Immediately before skin graft procedure and antimicrobial prophylaxis
Contamination	Type of bacterial flora in wound	After revision during skin graft procedure
Contamination	Type of bacterial flora in wound	5 to 7 days after skin graft procedure

Collaborators and Investigators

• Sponsor: Central Finland Hospital District
• Collaborators: University of Eastern Finland; Tampere University Hospital
• Investigators: Principal Investigator: Juha Paloneva, professor, Chief medical director

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2018
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 24, 2018
• First Submitted That Met QC Criteria: August 24, 2018
• First Posted (Actual): August 28, 2018

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Negative pressure wound therapy; Skin graft; split-thickness skin graft
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Fibrosis; Wounds and Injuries; Cicatrix; Surgical Wound Dehiscence
• Other Study ID 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