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NCT Number: NCT03900078

Incisional Negative Pressure Wound Therapy for Resection of Soft Tissue Tumors

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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Key information

Conditions

Soft Tissue Sarcoma Lipoma Neoplasms Neoplasms by Histologic Type Neoplasms, Adipose Tissue Neoplasms, Connective and Soft Tissue Sarcoma Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil

Bochum, North Rhine-Westphalia, 44789, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Incisional negative pressure wound therapy

Other

A negative pressure dressing is applied to the skin incision.

Wound dressing with adhesive tapes

Other

Regular adhesive wound tapes are applied over the closed skin.

Primary outcomes

  1. Amount of drainage fluid

    Time frame: up to 14 days postoperatively

    Measurement of total fluid amounts in drains and negative pressure device

Secondary outcomes

  1. Wound complications

    Time frame: 3 months

    Assessment of course of wound healing, necessary operative revisions, seroma formation

  2. Wound margin perfusion

    Time frame: 5 days postoperatively

    Measurement with laser doppler

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Registry information

Official study title

Inzisionelle Negative Drucktherapie Nach Resektion Von Weichteiltumoren - Eine Prospektive, Randomisierte, Kontrollierte Klinische Studie

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 2, 2019
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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