Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting

Wound Heal Clinical Trial

— TRUTH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03649308
• Other study ID #: 6U/2018
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 19, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Central Finland Hospital District
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cicatrix
• Skin Scarring
• Skin Wound
• Surgical Wound Dehiscence
• Wound
• Wound Breakdown
• Wound Heal
• Wound of Skin
• Wound Open
• Wounds and Injuries

Intervention

Device:
• Negative Pressure Wound Therapy
An immediate mobilization and negative pressure wound therapy (PICO) initiated after surgery.

Procedure:
• Conventional treatment
Traditional treatment with conventional wound dressing and 5 days of immobilization after surgery.

Locations

Country	Name	City	State
Finland	Central Finland Hospital	Jyväskylä
Finland	Tampere University Hospital	Tampere

Sponsors (3)

Lead Sponsor	Collaborator
Central Finland Hospital District	Tampere University Hospital, University of Eastern Finland

Country where clinical trial is conducted

Finland, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Contamination	Type of bacterial flora in wound	Immediately before skin graft procedure and antimicrobial prophylaxis
Other	Contamination	Type of bacterial flora in wound	After revision during skin graft procedure
Other	Contamination	Type of bacterial flora in wound	5 to 7 days after skin graft procedure
Primary	Between group difference in skin graft take	Split-thickness skin graft take ratio (percentage of surface area)	2 weeks after surgery
Secondary	Between group difference in skin graft take	Split-thickness skin graft take ratio (percentage of surface area)	5 to 7 days after surgery
Secondary	Between group difference in skin graft take	Split-thickness skin graft take ratio (percentage of surface area)	8 weeks after surgery
Secondary	Strength of pain (wound)	Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain)	5 to 7 days after surgery
Secondary	Strength of pain (wound)	Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain)	2 weeks
Secondary	Strength of pain (wound)	Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain)	8 weeks after surgery
Secondary	Strength of pain (wound)	Strength of pain in wound (Numeric rating scale 0 to 10; 0= no pain)	1 year after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	POSAS score (wound)	Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best) (wound)	8 weeks after surgery
Secondary	POSAS score (wound)	Patient and Observer Scar Assessment Scale (range 7 to 70 points; 7=best)(wound)	1 year after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Overall satisfaction	Overall satisfaction with treatment (Likert)	5 to 7 days after surgery
Secondary	Overall satisfaction	Overall satisfaction with treatment (Likert)	2 weeks after surgery
Secondary	Overall satisfaction	Overall satisfaction with treatment (Likert)	8 weeks after surgery
Secondary	Overall satisfaction	Overall satisfaction with treatment (Likert)	1 year after surgery
Secondary	Strength of itching (wound)	Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching)	5 to 7 days after surgery
Secondary	Strength of itching (wound)	Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching)	2 weeks after surgery
Secondary	Strength of itching (wound)	Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching)	8 weeks after surgery
Secondary	Strength of itching (wound)	Strength of itching in wound (Numeric rating scale 0 to 10, 0= no itching)	1 year after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Length of stay	Length of hospital ward stay due to wound treatment (days)	Until 8 weeks after surgery
Secondary	Number of visits	Number of visits to hospital due to wound treatment	Until 8 weeks after surgery