Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting

NCT03649308 | Active Not Recruiting

• 1 other identifier: 6U/2018
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Between group difference in skin graft take

  Split-thickness skin graft take ratio (percentage of surface area)

  2 weeks after surgery

Secondary Outcomes (32)

• Between group difference in skin graft take

  5 to 7 days after surgery

• Between group difference in skin graft take

  8 weeks after surgery

• Strength of pain (wound)

  5 to 7 days after surgery

• Strength of pain (wound)

  2 weeks

• Strength of pain (wound)

  8 weeks after surgery

Other Outcomes (3)

• Contamination

  Immediately before skin graft procedure and antimicrobial prophylaxis

• Contamination

  After revision during skin graft procedure

• Contamination

  5 to 7 days after skin graft procedure

Study Arms (2)

Negative Pressure Wound Therapy

EXPERIMENTAL

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

Conventional treatment

ACTIVE COMPARATOR

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

Interventions

Negative Pressure Wound Therapy DEVICE

An immediate mobilization and negative pressure wound therapy (PICO) initiated after surgery.

Negative Pressure Wound Therapy

Conventional treatment PROCEDURE

Traditional treatment with conventional wound dressing and 5 days of immobilization after surgery.

Conventional treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Wound requiring skin graft surgery
• Voluntary

You may not qualify if:

• 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)

Sponsors & Collaborators

• Central Finland Hospital District: lead
• Tampere University Hospital: collaborator
• University of Eastern Finland: collaborator

Study Sites (2)

Central Finland Hospital

Jyväskylä, 40620, Finland

Location

Tampere University Hospital

Tampere, 33521, Finland

Location

Related Publications (3)

• 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.

  PMID: 26940940 BACKGROUND

• 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.

  PMID: 24577227 BACKGROUND

• 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.

  PMID: 20825510 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries; Surgical Wound Dehiscence; Cicatrix

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Officials

• Juha Paloneva, professor

  Chief medical director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: August 28, 2018
• Study Start: September 19, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2)