SAVE Studie- SArcoma Surgery With Vacuum Enhanced Wound Treatment Randomised Study to Evaluate the Wound Management in Sarcoma Surgery

NCT06889532 | Recruiting DMC

• 1 other identifier: 2024-101270-BO-ff
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate local complications following sarcoma resection in the groin and thigh regions with regard to the planned wound closure method. To this end, temporary soft tissue coverage using a vacuum-assisted closure (VAC) system and delayed secondary closure with wound sutures and drainage placement will be compared to primary closure with drainage in terms of wound infections, revisions, and seroma formation.

Conditions

Soft Tissue Sarcoma (STS)

Keywords

randomized; controlled; vacuum therapy; sarcoma; soft tissue sarcoma

Outcome Measures

Primary Outcomes (6)

• Wound complication

  The primary objective of the study is to compare wound complications after vacuum therapy versus direct closure.

  3 Months

• Wound Infection

  3 Months

• Wound Seroma

  Seroma in Wound

  3 Months

• Lymphatic fistula

  Lymphatic fistula or Drainage secretion of \>50ml/24h after 5 postoperative days

  3 Months

• Wound Dehiscence

  Wound dehiscence

  3 Months

• Revision Surgery or conservative treatment

  If Revision surgery or antibiotic treatment is required due to a wound infection.

  3 Months

Secondary Outcomes (1)

• Risk factors for wound complications

  3 Months

Study Arms (2)

Intervention Group

ACTIVE COMPARATOR

Intervention Group: In this group, a vacuum-assisted closure (VAC) system is applied intraoperatively to seal the wound, followed by a secondary closure after 3-7 days.

Procedure: Intervention Group: In this group, a vacuum-assisted closure (VAC) system is applied intraoperatively to seal the wound, followed by a secondary closure after 3-7 days.

Control Group

NO INTERVENTION

Control Group: In this group, wound closure is performed using primary sutures or staples, combined with the placement of a subcutaneous Redon drainage system.

Interventions

Intervention Group: In this group, a vacuum-assisted closure (VAC) system is applied intraoperatively to seal the wound, followed by a secondary closure after 3-7 days. PROCEDURE

Intervention Group: In this group, a vacuum-assisted closure (VAC) system is applied intraoperatively to seal the wound, followed by a secondary closure after 3-7 days.

Intervention Group

Eligibility Criteria

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

You may qualify if:

• Patients must be over 18 years old.
• Patients of any gender and background can be included.
• The largest tumor diameter on imaging must be at least 5 cm. Preoperative imaging is required to assess tumor dimensions.
• Sarcomas must be located in the lower extremity or groin.
• Cases must be discussed preoperatively at an interdisciplinary tumor board.
• Patients must provide informed consent to participate in the study.

You may not qualify if:

• Tumors smaller than 5 cm and superficial masses.
• Patients with local recurrences or prior wound healing complications in the surgical area.
• Patients with ulcerating or infected tumors, or those requiring emergency surgery.
• Other Soft Tissue Tumors such as Kaposi sarcoma.
• for whom direct closure is not possible during the initial surgery due to the extent of resection.

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Maastricht University Medical Center: collaborator
• University Hospital, Basel, Switzerland: collaborator
• University Hospital Erlangen: collaborator
• Universitätsmedizin Mannheim: collaborator

Study Sites (1)

Universitätsklinikum Hamburg Eppendorf

Hamburg, Hamburg, 20246, Germany

RECRUITING

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Simone Dr. med. Schewe

CONTACT

015222841914; s.schewe@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study, "SAVE Study - SArcoma Surgery with Vacuum Enhanced Wound Treatment," is a prospective, ran-domized, controlled clinical trial aimed at comparing the effectiveness of two surgical approaches to optimize wound care following sarcoma resections. The study is designed as a multicenter trial. The study includes two arms: * Intervention Group: In this group, a vacuum-assisted closure (VAC) system is applied intraoperatively to seal the wound, followed by a secondary closure after 3-7 days. * Control Group: In this group, wound closure is performed using primary sutures or staples, combined with the placement of a subcutaneous Redon drainage system.

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: March 21, 2025
• Study Start: November 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)