Incisional Negative Pressure Wound Therapy for Resection of Soft Tissue Tumors

Soft Tissue Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03900078
• Other study ID #: 18-6411-BR
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: September 15, 2020

Study information

• Verified date: October 2020
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 15, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Lipoma
• Sarcoma
• Soft Tissue Sarcoma
• Tumor

Intervention

Other:
• Incisional negative pressure wound therapy
A negative pressure dressing is applied to the skin incision.
• Wound dressing with adhesive tapes
Regular adhesive wound tapes are applied over the closed skin.

Locations

Country	Name	City	State
Germany	Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil	Bochum	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of drainage fluid	Measurement of total fluid amounts in drains and negative pressure device	up to 14 days postoperatively
Secondary	Wound complications	Assessment of course of wound healing, necessary operative revisions, seroma formation	3 months
Secondary	Wound margin perfusion	Measurement with laser doppler	5 days postoperatively