Incisional Negative Pressure Wound Therapy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the outcome of incisional negative pressure wound therapy in preventing surgical site infections and wound complications (dehiscence) in high-risk patients undergoing complex spinal surgery.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Wound Vac Polypropylene Suture Pilot Study

NCT02929238

Wound Vac Suture

COMPLETED NA

Surgical Site Infection Rate After Intra-Abdominal Surgery Using Negative Pressure Wound Therapy at Initial Closure

NCT01924884

Surgical Wound Infection Wound; Abdomen, Abdominal Wall Surgery

COMPLETED

Negative Pressure Wound Therapy for Prevention of Poststernotomy Infection

NCT02020018

Surgical Wound Infection

COMPLETED NA

Wound Vac Bandage Comparison After Spinal Fusion

NCT03000010

Neuromuscular Scoliosis

COMPLETED NA

Use of Negative Pressure Wound Therapy in High Risk Surgical Closed Incisions

NCT02137447

High Risk Abdominal Wounds

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This randomized, controlled study will compare the outcomes of NPWT versus the outcomes of not using NPWT in post-operative wound management following a complex spinal surgery. The allocation of patients (no NPWT device versus applying an NPWT device) will be determined by computer-generated randomization. The following data will be collected to determine impact on the outcome of wound management (i.e., infection and wound dehiscence): age, gender, body mass index (BMI), dorsal fat, estimated blood loss during the surgical procedure, length of surgery, length of hospital stay, highest peri-operative glucose, medical comorbidities, and history of infection.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Spinal Deformity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

No Negative Pressure Wound Therapy Device

This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.

Group Type NO_INTERVENTION

No interventions assigned to this group

NPWT Arm Therapy

This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.

Group Type EXPERIMENTAL

Negative pressure wound therapy (NPWT)

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Negative pressure wound therapy (NPWT)

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* \>/= 18 years of age
* \>/= 3 level instrumented thoracic, lumbar, or thoracolumbar spinal fusion

Exclusion Criteria

* \< 18 years of age
* \< 3 level instrumented thoracic, lumbar, or thoracolumbar spinal fusion
* Spinal infection at time of surgery
* History of immunosuppression or chronic systemic infection
* Pregnancy
* Inability to provide informed consent

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No