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

NCT05451680 | Unknown

• 1 other identifier: U1020DE009
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Tumor

Outcome Measures

Primary Outcomes (1)

• Graft take

  good, partial or poor graft take (%)

  3 months

Secondary Outcomes (1)

• Adverse events

  3 months

Study Arms (2)

Negative-pressure treatment

EXPERIMENTAL

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.

Device: Negative pressure device

Conventional treatment

ACTIVE COMPARATOR

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.

Procedure: Conventional care

Interventions

Negative pressure device DEVICE

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

Negative-pressure treatment

Conventional care PROCEDURE

Conventional dressing postoperatively on the full-thickness skin graft

Conventional treatment

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

HUS Iho- ja allergiasairaala

Helsinki, 00250, Finland

Location

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: controlled study

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 11, 2022
• Study Start: August 1, 2020
• Primary Completion: January 1, 2024
• Study Completion: July 1, 2024
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)