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Negative Pressure Wound Therapy

Negative Pressure Wound Therapy for Sarcoma

N/A

Recruiting

Led By Lee R Leddy, MD

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients scheduled for surgical resection

Lower extremity soft tissue sarcoma necessitating radiation prior to surgical resection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is comparing two methods of dressing a postoperative wound: a traditional dry gauze dressing, and a negative pressure dressing that provides gentle suction on the wound.

Who is the study for?

This trial is for adults over 18 with lower extremity soft tissue sarcoma who have had radiation before surgery. They must be scheduled for surgical tumor removal and primary wound closure, willing to be randomly assigned a treatment, and able to participate fully. Those with allergies to adhesive tape, needing skin grafts or flap coverage, having repeat surgeries for cancer margins, or amputations are excluded.Check my eligibility

What is being tested?

The study compares two types of post-surgery wound dressings in patients treated with radiation for leg or thigh sarcomas: traditional dry gauze versus Prevana negative pressure dressing that applies gentle suction. The goal is to see if the negative pressure method better reduces healing complications after surgery.See study design

What are the potential side effects?

Potential side effects may include skin irritation from the dressings or allergic reactions to materials used in either the standard gauze or Prevana dressing. Negative pressure therapy might also cause discomfort due to suction on the wound.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for surgery to remove a part of my body.

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I need radiation before surgery for my leg sarcoma.

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My wound was closed with stitches or staples.

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I am older than 18 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Wound Complication Rate

Secondary outcome measures

Total Costs

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NPWT dressingExperimental Treatment1 Intervention

Group II: Standard dry gauze dressingPlacebo Group1 Intervention

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor

933 Previous Clinical Trials

7,394,455 Total Patients Enrolled

3 Trials studying Sarcoma

143 Patients Enrolled for Sarcoma

3MIndustry Sponsor

157 Previous Clinical Trials

31,314 Total Patients Enrolled

Lee R Leddy, MDPrincipal InvestigatorMedical University of South Carolins

Media Library

Prevana Dressing (Negative Pressure Wound Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02638298 — N/A

Sarcoma Research Study Groups: Standard dry gauze dressing, NPWT dressing

Sarcoma Clinical Trial 2023: Prevana Dressing Highlights & Side Effects. Trial Name: NCT02638298 — N/A

Prevana Dressing (Negative Pressure Wound Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02638298 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research initiative still accepting new participants?

"The information hosted on clinicaltrials.gov confirms that this medical study, which was initially unveiled on December 1st 2015, is actively recruiting patients at the current moment in time. The details of the trial were last amended on April 28th 2022."

Answered by AI

What is the participant size for this medical research?

"Affirmative. According to information hosted on clinicaltrials.gov, recruitment for this medical trial is still ongoing; it was first posted in December of 2015 and most recently updated on April 28th 2022. A total of 30 patients are being sought out from 1 particular centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Incisional Negative Pressure Wound Therapy for Preoperatively Irradiated Lower Extremity Soft Tissue Sarcoma Wounds

2015. "Incisional Negative Pressure Wound Therapy for Preoperatively Irradiated Lower Extremity Soft Tissue Sarcoma Wounds". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02638298.

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