Negative Pressure Therapy in Preventing Infection After Surgery in Patients With Colon, Rectal, Pancreatic, or Peritoneal Surface Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-10-31

Brief Summary

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

The purpose of this research study is to evaluate if a negative-pressure dressing placed over a surgical incision can reduce the risk of developing a surgical site infection compared to a commonly-used sterile gauze incision dressing. In this study, the negative-pressure dressing will be compared to a standard post-surgical sterile gauze dressing. In this study patients will either receive a negative-pressure dressing or a standard sterile gauze dressing

Related Clinical Trials

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

The Effect of Wound Problems Wound Dressing in Patients With Colorectal Cancer Surgery

NCT04735133

Colorectal Cancer Surgery Surgery--Complications +2 more

COMPLETED NA

Prophylactic NPWT to Reduce SSI in Colorectal Surgery

NCT03661814

Surgical Wound Infection

TERMINATED NA

Study Comparing Pursestring Wound Closure vs Conventional Closure to Reverse Stoma of Colorectal Cancer Patients

NCT02564224

Colorectal Cancer Stoma Closure Technic

NO_LONGER_AVAILABLE

Drainage After Rectal Excision for Rectal Cancer

NCT01269567

Rectal Cancer Surgery Randomized Clinical Trial Multicenter Study +1 more

COMPLETED PHASE3

The Influence of Different Fluid Therapy Measures on the Postoperative Outcome in Fast Track of Colon Cancer.（FTSlapCC)

NCT02991092

Colon Carcinoma

UNKNOWN NA

Detailed Description

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

PRIMARY OBJECTIVES:

I. To determine whether negative pressure therapy applied to closed laparotomy incisions can decrease the incidence of incisional surgical site infections in patients undergoing clean-contaminated resections for colorectal, pancreatic, and peritoneal surface malignancies compared to standard post-operative sterile gauze dressings.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive standard sterile dressing (SSD) over their closed laparotomy incision at the conclusion of their surgery.

ARM II: Patients receive negative pressure therapy (NPT) dressing over their closed laparotomy incision at the conclusion of their surgery.

After completion of study treatment, patients are followed up at 30 days.

Conditions

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

Colon Cancer Pancreatic Cancer Perioperative/Postoperative Complications Primary Peritoneal Cavity Cancer Rectal Cancer

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

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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

Arm I (SSD)

Patients receive SSD over their closed laparotomy incision at the conclusion of their surgery.

Group Type ACTIVE_COMPARATOR

wound care management

Intervention Type PROCEDURE

Receive SSD

Arm II (NPT)

Patients receive NPT dressing over their closed laparotomy incision at the conclusion of their surgery.

Group Type EXPERIMENTAL

wound care management

Intervention Type PROCEDURE

Receive NPT

Interventions

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

wound care management

Receive SSD

Intervention Type PROCEDURE

wound care management

Receive NPT

Intervention Type PROCEDURE

Eligibility Criteria

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

Inclusion Criteria

* Surgical resection for a colorectal, pancreatic, or peritoneal surface malignancy
* The scheduled procedure will be performed via midline laparotomy
* The planned procedure is a clean-contaminated (class II) case (includes gastric, small bowel, and colorectal resections, as well as bile or pancreatic duct transections)
* Ability to understand and the willingness to sign a written informed consent document (either directly or via a legally authorized representative)

Exclusion Criteria

* Emergent cases will not be included in the study
* Pregnant patients will not be included in the study as pregnancy is a relative contraindication for these types of surgical procedures
* Clean (class I), contaminated (class III) and dirty (class IV) procedures will likewise be excluded
* Patients on chronic immunosuppressive medications, including steroids, within the past three months
* Patients with a history of skin allergy to iodine or adhesive drapes
* The planned procedure involves foreign material (such as mesh or subcutaneous drains) being left in the subcutaneous space at the time of surgery (for example, a ventral hernia repair); surgical drains that are placed to drain an intraabdominal space and exit the abdominal wall remote from the incision are allowed in the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No