Surgical wound infection after cholecystectomy is one of the most common complications that increase morbidity and hospital costs. Wound infection control, using modern methods of wound healing, can reduce these complications. Negative-pressure wound therapy (NPWT) is a therapeutic technique using a vacuum dressing to promote healing in acute or chronic wounds and Excess fluid, debris and wound edema are removed.
(1) Main Objectives:
The aim of the present study is to investigate the effect of NPWT on the healing rate of acute infection following cholecystectomy.
(2) Design:
In this clinical trial study, 240 patients who underwent Cholecystectomy where divided into two groups based on a randomized block model. Cases of surgical wounds treated with NPWT, and control wounds were treated with classical treatment methods.
(3) Setting and conduct:
In control group after fascia repair, skin sutured and hydrofilm dressing was done alone.But In case group after fascia and before skin repair,an orang nelaton was put in this space and dressing was done.This nelaton connected to hemovac drain with -60 mmHg pressure. Patients in two group in duration 5 days after surgery was evaluate for wound hematoma, fascia dehiscence, wound infection and healing by clinical and labratory findings.
(4-a) inclusion criteria:patients with acute cholecystitis operated under open
procedure.
(4-b) exclusion criteria:age up to70; anemia; hypoxemia; diabetes mellitus; uremia; malnutrition; coagolopathy; recent vascular events ; CVD; COPD; recent pneumonia; gangrenous or emphysematous cholecystitis; gall bladder empyema; BMI up to35; vitamineA ,C ; steroid consumption; chemotherapy; operation period up to2.5 hour; bulky subcutaneous tissue.
(5) Intervention:
In case group negative wound pressure therapy with hemovac drain was done. In control group hydrofilm dressing was done daily alone.
(6) Main outcome measures:
Surgical site wound infection, wound healing.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202159015N1
Registration date:2012-10-25, 1391/08/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-10-25, 1391/08/04
Registrant information
Name
Mohsen Norooz Olyaei
Name of organization / entity
Arak University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1312 1006
Email address
dr.maliyaee@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Budget Of Vice Chancellery For Research And Education, Arak University Of Medical Sciences
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of treatment with Negative Pressure on
Wound Infection and Healing following open cholecystectomy
Public title
Negative Pressure Effect on Wound Healing
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
patients with acute cholecystitis operated under open procedure.
Exclusion criteria:
age up to70; anemia; hypoxemia; diabetes mellitus; uremia; malnutrition; coagolopathy; recent vascular events ; CVD; COPD; recent pneumonia; gangrenous or emphysematous cholecystitis; gall bladder empyema; BMI up to35; vitamineA ,C ; steroid consumption; chemotherapy; operation period up to2.5 hour; bulky subcutaneous tissue.
Age
To 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
240
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
nil
Secondary trial Id
nil
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Vice Chancellery For Research And Education, Arak University Of Medical Sciences
Street address
Post Box: 1884, Vice Chancellery Of Research And Education, Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Postal code
38481-76941
Approval date
2011-08-17, 1390/05/26
Ethics committee reference number
90-112-1
Health conditions studied
1
Description of health condition studied
Surgical Site Infection and Wound Healing
ICD-10 code
L08.9
ICD-10 code description
Local infection of skin and subcutaneous tissue, unspecified
Primary outcomes
1
Description
wound infection
Timepoint
5 days after intervention
Method of measurement
clinical findings and wound culture
2
Description
wound healing
Timepoint
5 days after intervention
Method of measurement
pathological servey of wound biopsy
Secondary outcomes
1
Description
wound hematoma
Timepoint
5 days after intervention
Method of measurement
bedside clinical findings
2
Description
fascial dehiscence
Timepoint
5 days after intervention
Method of measurement
bedside clinical findings and sonogeraphy
Intervention groups
1
Description
In case group a orange nelaton was put at the space superior to fascia and inferior to skin and was connected to hemovac drain suction with -60
mmhg negative pressure.skin sutured interrupted and hydrofilm dressing was done.
Category
Prevention
2
Description
In control group skin repaired with nylon 2-0 interrupted suture and hydrofilm dressing was changed daily.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Valieasr Hospital, Arak
Full name of responsible person
Dr. Mohsen Norooz Olyaei
Street address
Surgery Department, Valieasr Hospital, Valieasr Sq, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellery For Research And Education, Arak University Of Medical Sciences
Full name of responsible person
Dr.Hekmatpoo
Street address
Post Box: 1884, Vice Chancellery For Research And Education, Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellery For Research And Education, Arak University Of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Dr .Gholamreza Noori
Position
Thorax Surgeon, Assistant Professor
Other areas of specialty/work
Street address
Surgery Department, Valieasr Hospital, Valieasr Sq, Arak
City
Arak
Postal code
38149-5-7558
Phone
+98 86 1222 2007
Fax
+98 86 1222 0224
Email
Noori51@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Dr.Gholamreza Noori
Position
Thorax Surgeon, Assistant Professor
Other areas of specialty/work
Street address
Surgery Department, Valieasr Hospital, Valieasr Sq, Arak
City
Arak
Postal code
38149-5-7558
Phone
+98 86 1222 2007
Fax
+98 86 1222 0224
Email
Noori51@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University Of Medical Sciences
Full name of responsible person
Dr.Mohsen Norooz Olyaei
Position
Resident of General Surgery
Other areas of specialty/work
Street address
Surgery Department, Valieasr Hospital, Valieasr Sq, Arak