- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01656044
Negative Pressure Therapy in Preventing Infection After Surgery in Patients With Colon, Rectal, Pancreatic, or Peritoneal Surface Cancer
The Effect of Negative Pressure Therapy on Incisional Surgical Site Infections
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
North Carolina
-
Winston-Salem, North Carolina, Förenta staterna, 27157
- Comprehensive Cancer Center of Wake Forest University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Arm I (SSD)
Patients receive SSD over their closed laparotomy incision at the conclusion of their surgery.
|
Receive SSD
Receive NPT
|
Experimentell: Arm II (NPT)
Patients receive NPT dressing over their closed laparotomy incision at the conclusion of their surgery.
|
Receive SSD
Receive NPT
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Rate of incisional surgical site infection (SSI), which includes superficial incisional SSIs and deep incisional SSIs as defined by the Center of Disease Control and Prevention
Tidsram: 30 days
|
Results will be analyzed initially using descriptive statistics.
The proportion of SSI in the NPT group will be compared to the standard post-operative dressing group using a chi square test of proportions.
|
30 days
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Rates of organ/space SSIs, seromas, hematomas, incisional cellulitis, and wound opening for any reason
Tidsram: 30 days
|
30 days
|
The cost of NPT and SSD, as well as estimate additional costs associated with incisional SSIs in affected patients
Tidsram: 30 days
|
30 days
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Perry Shen, Wake Forest University Health Sciences
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB00020105
- NCI-2012-00624 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
- CCCWFU 99212 (Annan identifierare: Wake Forest University Health Sciences)
Läkemedels- och apparatinformation, studiedokument
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