high-fiber/low fat for Surgical Site Infections

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Stanford Health Care, Stanford, CA
Surgical Site Infections+1 More
high-fiber/low fat - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study is evaluating whether a specific diet can change the gut microbiome and whether those changes translate into better surgical outcomes.

See full description

Eligible Conditions

  • Surgical Site Infections

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether high-fiber/low fat will improve 1 primary outcome and 3 secondary outcomes in patients with Surgical Site Infections. Measurement will happen over the course of two weeks prior to surgery.

30 days after surgery
Surgical outcomes with short-term pre-operative diet intervention
two weeks prior to surgery
Adherence to short-term pre-operative diet intervention
Changes in gut microbiome before surgery with short-term pre-operative diet intervention
Month 1
Changes in gut microbiome after surgery with short-term pre-operative diet intervention

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Control Arm
1 of 3
Fermented
1 of 3
High Fiber/low fat
1 of 3
Active Control
Experimental Treatment

This trial requires 60 total participants across 3 different treatment groups

This trial involves 3 different treatments. High-fiber/low Fat is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Fermented
Behavioral
Patients will receive sample meals and education/support, will be asked to follow this diet for 10 days.
High Fiber/low fat
Behavioral
Patients will receive sample meals and education/support, will be asked to follow this diet for 10 days.
Control ArmStandard care - patients will not receive specific dietary advice.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days after surgery
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 30 days after surgery for reporting.

Who is running the study

Principal Investigator
C. K.
Prof. Cindy Kin, Assistant Professor of Surgery
Stanford University

Closest Location

Stanford Health Care - Stanford, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
undergoing major abdominal colorectal surgery with intestinal resection in 2 or more weeks

Patient Q&A Section

What are common treatments for surgical wound infection?

"Surgical wounds may be treated by either a clean closure or, alternatively, by the use of topical or systemic antibiotics. Wounds treated by clean closure have a higher infection rate than wounds treated by the use of topical or systemic antibiotics." - Anonymous Online Contributor

Unverified Answer

How many people get surgical wound infection a year in the United States?

"answer: Based on the Centers for Disease Control and Prevention’s most recent statistics on wound care care infections, one person in every 10,000 will get a wound care infection in the U.S. each year. Based on the data cited from the literature (Kahn 2006; Mavila 2007), the estimated incidence of chronic wound infections among chronically disabled individuals ranges from 26 to 79 percent (Kahn 2006, Mavila 2007)." - Anonymous Online Contributor

Unverified Answer

Can surgical wound infection be cured?

"The cure rate is not satisfactory for a number of indications for treatment of surgical site infections (SSIs) including superficial SSI, VAP, S. aureus, MRSE, and prosthesis-related SSI." - Anonymous Online Contributor

Unverified Answer

What causes surgical wound infection?

"In this large retrospective database review, we did not identify a set of preoperative factors which correlate with a risk of infection. We did not feel a need to alter the routine preoperative evaluation of patients undergoing elective procedures, but we recommend more frequent and more detailed evaluation in high-risk patients, especially those with diabetes, a history of prior operation(s) or intra-prostatic abscess, and in those with a recent history of antibiotic use." - Anonymous Online Contributor

Unverified Answer

What is surgical wound infection?

"Surgical wound infection is a serious and often life-threatening complication. Preventing wound infection can be as simple as using the proper technique, such as routine hand hygiene." - Anonymous Online Contributor

Unverified Answer

What are the signs of surgical wound infection?

"Signs of surgical wound infection may include excessive drainage, raised temperature and increased pain. Often infections are asymptomatic. However, in a minority patients a fever or other clinical signs may indicate infection." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in high-fiber/low fat for therapeutic use?

"There are several therapeutic benefits of incorporating increased fiber content into food products, including an improved bioavailability of food constituents and absorption of soluble fibers. Moreover, the intake of adequate food constituents and soluble fiber can significantly reduce the risk of developing postprandial distress syndrome." - Anonymous Online Contributor

Unverified Answer

What does high-fiber/low fat usually treat?

"In conclusion, this meta-analysis found that HF/LF diet can be as useful as HMW or LMW diet in improving the healing of surgical wounds without an increase of other adverse events." - Anonymous Online Contributor

Unverified Answer

Is high-fiber/low fat safe for people?

"The consumption of [10% fiber, 0.9% fat milk product] is safe for people with diabetes; [10% fiber, 4% fat milk product] can be safely consumed by those with normal blood glucose." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating surgical wound infection?

"Antibiotics, especially for surgical-site infections, are effective enough to decrease infection rates drastically. Surgical wound infections become a deadly disease by destroying tissues and organs. Antibiotics help stop the disease from spreading within a patient. Antibiotics help stop infection by destroying the organism, which can then make the body feel strong and healthy. More importantly, the use of medical devices can help reduce infection rates. There are more modern kinds of wound infection that help doctors find a treatment. Doctors know that antiseptic wash is effective against certain kinds of infections. The wash can be used before and after surgery. Doctors can take precautions to prevent any other types of contamination as well." - Anonymous Online Contributor

Unverified Answer

Does surgical wound infection run in families?

"Since the first description of bacterial colonization of wound sites in 1959, many investigators in the fields of obstetrics and gynecology and surgery have assumed that the occurrence of surgical wound infection is a consequence of environmental factors other than maternal or medical history. We believe that the clinical presentation of surgical wound infection in each patient is an important marker of the presence of environmental factors. It is clear that a genetic component of the disease must exist. As an example of environmental factor, we hypothesize that an increased number of neutrophils in wounds reflects increased serum activity of this neutrophil subpopulation. The authors hypothesize that a specific cytokine cascade may be involved in inducing necropsy granulomas and abscesses in these patients." - Anonymous Online Contributor

Unverified Answer

What is the latest research for surgical wound infection?

"Despite advances in antibiotic use and infection control strategies, the incidence of surgical site infections is increasing, and there is evidence that many types of these infections are complicated by resistant organisms. This article provides a state-of-the-art review of current research to determine whether there are ways to reduce the incidence and progression of these infections." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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