Back to results

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

Primary Purpose

Skin Tumor

Status

Recruiting

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

Negative pressure device

Conventional care

About this trial

This is an interventional treatment trial for Skin Tumor

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

HUS Iho- ja allergiasairaalaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Negative-pressure treatment

Conventional treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Graft take

good, partial or poor graft take (%)

Secondary Outcome Measures

Adverse events

Necrosis, infection, hematoma/seroma (%)

Full Information

NCT ID

NCT05451680

First Posted

July 4, 2022

Last Updated

July 8, 2022

Sponsor

Helsinki University Central Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05451680

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2020 (Actual)

Primary Completion Date

January 1, 2024 (Anticipated)

Study Completion Date

July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Helsinki University Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Skin Tumor

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

controlled study

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Negative-pressure treatment

Arm Type

Experimental

Arm Description

Arm Title

Conventional treatment

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Negative pressure device

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Conventional care

Intervention Description

Conventional dressing postoperatively on the full-thickness skin graft

Primary Outcome Measure Information:

Title

Graft take

Description

good, partial or poor graft take (%)

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Adverse events

Description

Necrosis, infection, hematoma/seroma (%)

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

110 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Vivian Lindholm, MD

Phone

+35840 5626238

vivian.lindholm@hus.fi

Facility Information:

Facility Name

HUS Iho- ja allergiasairaala

City

Helsinki

ZIP/Postal Code

00250

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Katariina Hannula-Jouppi, Docent

Phone

+3589 471 86355

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs