Incisional Negative Pressure Wound Therapy for Resection of Soft Tissue Tumors

NCT03900078 | Completed

• 1 other identifier: 18-6411-BR
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Tissue Sarcoma; Lipoma; Tumor

Outcome Measures

Primary Outcomes (1)

• Amount of drainage fluid

  Measurement of total fluid amounts in drains and negative pressure device

  up to 14 days postoperatively

Secondary Outcomes (2)

• Wound complications

  3 months

• Wound margin perfusion

  5 days postoperatively

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Other: Wound dressing with adhesive tapes

Incisional negative pressure group

EXPERIMENTAL

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

Other: Incisional negative pressure wound therapy

Interventions

Incisional negative pressure wound therapy OTHER

A negative pressure dressing is applied to the skin incision.

Incisional negative pressure group

Wound dressing with adhesive tapes OTHER

Regular adhesive wound tapes are applied over the closed skin.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• No primary skin closure.
• Skin infection in area of operation (e.g. acne inversa).

Sponsors & Collaborators

• Ruhr University of Bochum: lead

Study Sites (1)

Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil

Bochum, North Rhine-Westphalia, 44789, Germany

Location

MeSH Terms

Conditions

Sarcoma; Lipoma; Neoplasms

Interventions

Bandages

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms, Adipose Tissue

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Björn Behr, MD

  Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum

  PRINCIPAL INVESTIGATOR

• Mehran Dadras, MD

  Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Department of Plastic Surgery

Model Details: RCT with two therapy arms.

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 2, 2019
• Study Start: December 1, 2018
• Primary Completion: August 1, 2020
• Study Completion: September 15, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)