Incisional Negative Pressure Wound Therapy for Resection of Soft Tissue Tumors

Not Applicable

Completed

• Conditions: Soft Tissue Sarcoma; Lipoma; Tumor
• Interventions: Other: Incisional negative pressure wound therapy; Other: Wound dressing with adhesive tapes

• Registration Number: NCT03900078
• Lead Sponsor: Ruhr University of Bochum

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-12-01
• Study First Submitted: 2019-03-26
• Study First Submitted QC: 2019-04-01
• Study First Posted: 2019-04-02
• Primary Completion: 2020-08-01
• Study Completion: 2020-09-15
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-07
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Incisional negative pressure group	Incisional negative pressure wound therapy	After subcuticular skin suture, patients receive an incisional negative pressure dressing for 5 days.
Control group	Wound dressing with adhesive tapes	After subcuticular skin suture, patients receive standard dressing with adhesive wound tapes.

Primary Outcome Measures

Name	Time	Method
Amount of drainage fluid	up to 14 days postoperatively	Measurement of total fluid amounts in drains and negative pressure device

Secondary Outcome Measures

Name	Time	Method
Wound complications	3 months	Assessment of course of wound healing, necessary operative revisions, seroma formation
Wound margin perfusion	5 days postoperatively	Measurement with laser doppler

Trial Locations

Locations (1)

Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil; 🇩🇪 Bochum, NRW, Germany