Incisional Negative Pressure Wound Therapy for Resection of Soft Tissue Tumors

Ruhr University of Bochum

Status: Completed

Conditions: Lipoma; Soft Tissue Sarcoma; Tumor

Treatments: Other: Wound dressing with adhesive tapes; Other: Incisional negative pressure wound therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03900078

18-6411-BR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Control group

Active Comparator group

Description:

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

Treatment:

Other: Wound dressing with adhesive tapes

Incisional negative pressure group

Experimental group

Description:

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

Treatment:

Other: Incisional negative pressure wound therapy