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

A Randomized Study on the Effect of Negative-pressure Wound Therapy on Below-the-knee Skin Cancer Graft Reconstruction Complications

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05451680

Enrollment

Registered

2022-07-11

Start date

2020-08-01

Completion date

2024-07-01

Last updated

2023-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Tumor

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.

Interventions

DEVICENegative pressure device

Negative-pressure therapy postoperatively on the full-thickness skin graft

PROCEDUREConventional care

Conventional dressing postoperatively on the full-thickness skin graft

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

controlled study

Eligibility

Sex/Gender

ALL

Age

18 Years to 110 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Graft take	3 months	good, partial or poor graft take (%)

Secondary

Measure	Time frame	Description
Adverse events	3 months	Necrosis, infection, hematoma/seroma (%)

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026