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Incisional Negative Pressure Wound Therapy for Resection of Soft Tissue Tumors

NCT ID: NCT03900078

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-09-15

Brief Summary

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This study is aimed to examine the value of incisional negative pressure therapy after resection of soft tissue tumors. Its a prospective randomized trial comparing incisional negative pressure to standard wound dressings.

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Detailed Description

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Wound healing after resection of large soft tissue tumors is often impaired by large dead space and fluid collection, potentially resulting in seroma formation and infection. Aim of the study is to compare negative pressure wound therapy to standard wound dressing in terms of quantity of drainage fluid and wound healing complications.

Conditions

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Soft Tissue Sarcoma Lipoma Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT with two therapy arms.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

After subcuticular skin suture, patients receive standard dressing with adhesive wound tapes.

Group Type ACTIVE_COMPARATOR

Wound dressing with adhesive tapes

Intervention Type OTHER

Regular adhesive wound tapes are applied over the closed skin.

Incisional negative pressure group

After subcuticular skin suture, patients receive an incisional negative pressure dressing for 5 days.

Group Type EXPERIMENTAL

Incisional negative pressure wound therapy

Intervention Type OTHER

A negative pressure dressing is applied to the skin incision.

Interventions

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Incisional negative pressure wound therapy

A negative pressure dressing is applied to the skin incision.

Intervention Type OTHER

Wound dressing with adhesive tapes

Regular adhesive wound tapes are applied over the closed skin.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Soft tissue tumor of extremities or trunk with expected resection of \>10cm tissue in any dimension.

Exclusion Criteria

* No primary skin closure.
* Skin infection in area of operation (e.g. acne inversa).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruhr University of Bochum

OTHER

Sponsor Role lead

Responsible Party

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Mehran Dadras, MD

Consultant, Department of Plastic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Björn Behr, MD

Role: PRINCIPAL_INVESTIGATOR

Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum

Mehran Dadras, MD

Role: STUDY_DIRECTOR

Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum

Locations

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Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil

Bochum, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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18-6411-BR

Identifier Type: -

Identifier Source: org_study_id

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