Negative-pressure Wound Therapy on Full-thickness Skin Grafts of the Lower Leg

Not Applicable

Active, not recruiting

• Conditions: Skin Tumor
• Interventions: Device: Negative pressure device; Procedure: Conventional care

• Registration Number: NCT05451680
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

This randomized controlled non-sponsored trial on 60 patients evaluates if a portable negative-pressure device improves graft-take and decrease the risk of surgical complications for skin-cancer surgeries below the knee.

Detailed Description

Annually, 12 000 skin cancers are diagnosed in Finland. This randomized controlled non-sponsored trial evaluate if a portable negative-pressure device improves graft-take and decrease the risk of surgical complications. 60 patients over 18 years of age are included and randomly assigned to either the negative pressure-treatment group or the conventional treatment group. At the control appointment one-week postsurgery, graft take is documented as a primary outcome and any complications (necrosis, infection, hematoma/seroma) and adverse events (pain, skin reactions) as secondary outcomes. Adverse events are evaluated by a phone call 3 weeks postsurgery and based on medical records 3 months postsurgery.

Study Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2022-07-04
• Study First Submitted QC: 2022-07-08
• Study First Posted: 2022-07-11
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-19
• Last Update Posted: 2023-11-21
• Primary Completion: 2024-01-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• from referrals received by the Unit, or from patients undergoing follow-up who have skin cancer (basal cell carcinoma, squamous cell carcinoma or melanoma) or suspected skin cancer below the knee

Exclusion Criteria

• Toe lesion, bleeding disorder, severe dementia, critical peripheralischemia, or skin disease that is expected to impair wound healing, such as pyoderma gangrenosum

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Negative-pressure treatment	Negative pressure device	A negative pressure wound dressing is placed over the skin graft. Patients are started on compression therapy after surgery, unless there are contraindications, and standard oral and written postoperative immobilization and other treatment instructions are given.
Conventional treatment	Conventional care	A conventional antimicrobial wound dressing is placed on top of the graft. Patients are started on compression therapy after surgery, unless there are contraindications, and standard oral and written postoperative immobilization and other treatment instructions are given.

Primary Outcome Measures

Name	Time	Method
Graft take	3 months	good, partial or poor graft take (%)

Secondary Outcome Measures

Name	Time	Method
Adverse events	3 months	Necrosis, infection, hematoma/seroma (%)

Trial Locations

Locations (1)

HUS Iho- ja allergiasairaala; 🇫🇮 Helsinki, Finland