Trial Outcomes & Findings for Incisional Negative Pressure Wound Therapy for Preoperatively Irradiated Lower Extremity Soft Tissue Sarcoma Wounds (NCT NCT02638298)

Results Overview

To estimate the wound complication rate of post-operative negative pressure dressings and traditional dry dressings, and risk of secondary interventions after resection of soft tissue sarcoma in lower extremities that have received pre-operative radiation. Post-operative pain severity assessed by Visual analogue scale at 2 weeks and 6 months post-operatively where visual analogue scale ranges from zero to ten where (0 = no pain, 10 = maximum pain imaginable).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

163 participants

Primary outcome timeframe

longitudinally up to 6 months postoperatively

Results posted on

2025-08-07

Participant Flow

Patients were randomized to NPWT or dry gauze dressing following oncologic resection and were excluded in the settings of amputation, revision, or flap coverage

Participant milestones

Participant milestones
Measure	NPWT Dressing Prevana Dressing: negative pressure wound therapy (NPWT) dressing	Standard Dry Gauze Dressing Standard Dry Gauze Dressing: Standard Dry Gauze Dressing
Overall Study STARTED	81	79
Overall Study COMPLETED	81	79
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gender data were not collected and therefore, sex-specific analyses of baseline characteristics and outcomes cannot be performed.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NPWT Dressing n=81 Participants Prevana Dressing: negative pressure wound therapy (NPWT) dressing. Baseline characteristics were not collected for sex of participants, nor was the age documented as a result of all participants being over the age of 18.	Standard Dry Gauze Dressing n=79 Participants Standard Dry Gauze Dressing: Standard Dry Gauze Dressing. Baseline characteristics were not collected for sex of participants, nor was the age documented as a result of all participants being over the age of 18.	Total n=160 Participants Total of all reporting groups
Age, Customized >=18 years old	81 Participants n=81 Participants	79 Participants n=79 Participants	160 Participants n=160 Participants
Sex: Female, Male Female	0 Participants Gender data were not collected and therefore, sex-specific analyses of baseline characteristics and outcomes cannot be performed.	0 Participants Gender data were not collected and therefore, sex-specific analyses of baseline characteristics and outcomes cannot be performed.	0 Participants Gender data were not collected and therefore, sex-specific analyses of baseline characteristics and outcomes cannot be performed.
Sex: Female, Male Male	0 Participants Gender data were not collected and therefore, sex-specific analyses of baseline characteristics and outcomes cannot be performed.	0 Participants Gender data were not collected and therefore, sex-specific analyses of baseline characteristics and outcomes cannot be performed.	0 Participants Gender data were not collected and therefore, sex-specific analyses of baseline characteristics and outcomes cannot be performed.
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	81 participants n=81 Participants	79 participants n=79 Participants	160 participants n=160 Participants

PRIMARY outcome

Timeframe: longitudinally up to 6 months postoperatively

Population: Post-operative pain severity assessed by Visual analogue scale at 2 weeks and 6 months post-operatively where visual analogue scale ranges from zero to ten where (0 = no pain, 10 = maximum pain imaginable).

To estimate the wound complication rate of post-operative negative pressure dressings and traditional dry dressings, and risk of secondary interventions after resection of soft tissue sarcoma in lower extremities that have received pre-operative radiation. Post-operative pain severity assessed by Visual analogue scale at 2 weeks and 6 months post-operatively where visual analogue scale ranges from zero to ten where (0 = no pain, 10 = maximum pain imaginable).

Outcome measures

Outcome measures
Measure	NPWT Dressing n=81 Participants Prevana Dressing: negative pressure wound therapy (NPWT) dressing	Standard Dry Gauze Dressing n=79 Participants Standard Dry Gauze Dressing: Standard Dry Gauze Dressing
Wound Complication Rate Post-operative pain severity assessed by Visual analogue scale at 2 weeks postoperatively.	3.7 score on a scale Standard Deviation 2.2	3.7 score on a scale Standard Deviation 2.5
Wound Complication Rate Post-operative pain severity assessed by Visual analogue scale at 6 months postoperatively.	2.1 score on a scale Standard Deviation 1.9	2.2 score on a scale Standard Deviation 1.9

Adverse Events

NPWT Dressing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Dry Gauze Dressing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Leddy

Medical University of South Carolina

Phone: 843-876-1119

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place