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

High Risk Abdominal Wounds Clinical Trial

Official title:

A Prospective Observational Study of the Use of Negative Pressure Wound in High Risk Surgical Closed Incisions.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02137447
• Other study ID #: 2013P002484
• Status: Completed
• Phase: Phase 4
• First received: May 8, 2014
• Last updated: September 9, 2016
• Start date: May 2014
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the use of Negative Pressure Wound Therapy in high risk surgical wounds to evaluate the rate of surgical site infections (SSIs).

Hypothesis:

Historically, the average rates of infective complications in surgical wounds types are 7.7% in clean wounds, 15% for contaminated and 35-40% for dirty wounds. The application of Prevena ™ Incision Management System (Kinetic Concepts Inc, San Antonio, TX) is expected to reduce these rates by 50%.

Description:

Wound infections continue to be a common and costly problem after surgery. Surgical site infections (SSIs) are the second most common type of health care - associated infections (HAI), occurring in 2% to 5% of patients undergoing surgery in the United States. This percentage corresponds to approximately 300,000 to 500,000 surgical site infections (SSIs) estimated to occur each year.

Most SSIs that do not involve implants are diagnosed within 3 weeks post--operatively . SSIs lead to increased hospital stay, cost, and risk of death. The cost attributable to SSI range from $3,000 to $29,000 per SSI per patient depending on the type of operation; thus, the total annual cost approximately reaches the $10 billions. On other analyses documented nearly 1 million additional inpatient-days and $1.6 billion in excess costs , as well as up to twice the costs of a patient without SSI. Moreover, SSIs increase mortality risk by 2 to 11 fold 11, while the 77% of deaths in patients with SSI are attributed directly to the SSIs. Several organizations have put forth guidelines for definition and recommendations to decrease their incidence. Attempts have been made to stratify patients into various categories on the basis of the type of surgical procedure and risk factors the patients have, including diabetes, malnutrition, and hypoxemia. These systems have been used to develop criteria for the prevention of wound infection.

Appropriate timing and dosing of antibiotics, type of skin preparation, temperature of the patient in the operating room, blood oxygen level of the patient during surgery, and management of blood glucose levels all have been standardized in an attempt to decrease wound infection rates . In addition, debridement of all tissue that may contribute to wound infection, particularly ischemic skin and subcutaneous tissue, is standard surgical procedure. Standardization has led to a small decrease in incidence but has not led to a significant reduction in the overall rate. One reason for this is the multifactorial nature of SSI development. Factors regarding patients and pre-operative status, operative procedures and intra-operative events, as well as postoperative course, all need to be addressed, and there is not a complete understanding of their range and impact. What is known is that at the time of wound closure, one needs a minimal number of bacteria in the wound, and the wound itself must be reasonably well perfused and oxygenated. After surgery, wound perfusion and oxygenation are evaluated by clinical appearance. If the wound does not appear ischemic, it is assumed that perfusion and oxygenation are adequate. Unfortunately, this has never been quantified. Negative-pressure wound therapy (NPWT) has been used to speed the healing of open wounds.

How this occurs is not completely understood, but increased generation of granulation tissue at the margins of the open wound implies increased generation of blood vessels and substances needed to promote wound healing.

The theory of negative pressure is the stimulation of wound healing on the basis of improved perfusion to the wound. This has been seen in open wounds and has recently been applied to closed surgical wounds thought to be at high risk for infection. Negative-pressure wound therapy was also applied to closed wounds in an attempt to improve wound perfusion and oxygenation, which in theory would eliminate these two variables from the wound infection equation.

Techniques - Procedures Complete closure of the abdominal wall and skin follows the completion of the index surgical procedure. Closed suction drains may be used at the time of skin closure in any patient who requires skin flap elevation to attain skin closure. Skin closure will be accomplished with dermal sutures and / or staples. Wound coverage will be done with the NPWT Prevena ™ Incision Management System (Kinetic Concepts Inc, San Antonio, TX). The application of the NPWT will be done as per manufacturer's instructions of use. The application of continuous negative pressure will be applied at 125 mm Hg.Antibiotics will be given to all patients. The post-operative use of antibiotics in the clear contaminated and contaminated cases will be 24-hour of prophylactic administration. The post-operative use of antibiotics for the dirty (infected) cases will be of therapeutic administration, as clinically indicated. In infected patients, cultures will be taken at the time of the index procedure, and the antibiotic treatment will be targeted to the culture results. Wounds will be assessed every 48 hours by dressing changes, and also at the time of final dressing removal and at 2 and 4 weeks after surgery. The dressing removal will take place at discharge OR at 5 - 7 post-operative days OR if clinically indicated, whichever comes first. Post-discharge follow-up The patients will be followed-up per routine at the surgical clinic. At 2 and 4 weeks after the date of the operation a formal evaluation will take place. Both evaluations must be in person at the surgical clinic.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• All five of the following criteria must be present for enrollment into the study:

1. Signed written informed consent must be provided by the patient or by patient's legally acceptable representative, if patient unable to consent. In the case of penetrating abdominal trauma, and only in the case of penetrating abdominal trauma, the patient or surrogate will have less than 24 hours to decide and sign consent due to the nature of the condition and situation.

2. Age > 18 years

3. Abdominal operation entering the peritoneal cavity under general anesthesia for colostomy reversal OR excision of a pilonidal sinus OR after penetrating abdominal trauma.

4. Clean - contaminated OR contaminated OR dirty wound (as defined by Wound Infection Surveillance) OR use of skin flaps for skin closure.

5. Complete closure of the surgical wound including the skin.

Exclusion Criteria:

• 1) Known allergic reaction at the wound dressing parts of the Prevena ™ Incision Management System.

(Included but not limited to: sensitivity to silver, allergic or hypersensitivity reaction to acrylic adhesives).

2) Inability to close the abdominal wall at the index procedure. 3) Inability to close the skin at the index procedure. 4) Patients under 18 years old. 5) Pregnant women test

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• High Risk Abdominal Wounds
• Wounds and Injuries

Intervention

Device:
• Negative Pressure treatment

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Prevena Incision Management System	Incidence of SSIs within 1 month (4 weeks) from the index operation. SSI is defined by the Centers for Disease Control and Prevention's National Healthcare Surveillance Network	30 days	No
Secondary	Composite secondary outcomes	Secondary (composite) outcomes: other non infectious abdominal wound complications,; damage to the skin caused by the dressing; need to end the treatment prior the discharge OR prior the 5 -7 post- operative days.; need for re-application of the system for any reason	4 weeks	No