This single-blind clinical trial is designed to evaluate the effect of probing of contaminated surgical wounds. People between 12-60 years who underwent surgery for perforated appendicitis via Mc-Burney incision, after obtaining informed consent are placed in control or intervention group randomly (a total of 114 patients). Antibiotic prophylaxis and surgical techniques and postoperative care will be the same in both groups. Just a simple daily dressing is performed in the control group. In the intervention group, probing the wound by dipping a sterile dry cotton-tipped swab between the stitches down to the external oblique fascia is done and then simple dressing is performed. Probing only done once a day during hospitalization for wound drainage. During hospitalization all patients are assessed and examined daily of vital signs, white blood cell count, and any signs of wound infection (purulent or abnormal discharge, redness, swelling, pain). The examiner is unaware of the type of intervention (single-blinded). In case of infection, wound is opened and washing the wound twice daily is performed with normal saline. All patients are examined one week and three weeks after discharge to follow wound infection and wound healing process.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014082618939N1
Registration date:2014-10-06, 1393/07/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-10-06, 1393/07/14
Registrant information
Name
Amir Hosein Parniaei
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3426 5183
Email address
ah.parniaee@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2014-10-07, 1393/07/15
Expected recruitment end date
2015-03-06, 1393/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A survey of wound probing effectiveness on surgical site infection in patients with perforated appendicitis
Public title
probing effect in contaminated surgical wounds
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1.Ages between 12-60 years old; 2.Operation via Mc-Burney incision due to acute appendicitis; 3.Evidences of perforated appendicitis e.g., a hole, fecalith, abscess or puss observed by surgeon.
Exclusion criteria: 1.Non perforated appendicitis; 2.Incision other than Mc-Burney; 3.Pregnancy; 4.Ages less than 12 years old and more than 60 years old; 5.Severe sepsis and Immunodeficiency, diabetes, cardiovascular or renal or respiratory or hepatic insufficiency; 6.Body mass index higher than 30.
Age
From 12 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
114
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
In this survey, after obtaining informed consent and based on inclusion and exclusion criteria, patients are entered in study. A number is granted to each patient in order of entering to study; (from 1 to 114). To randomization, odd numbers are placed in the intervention group and even numbers in the control group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research, Building No.2, Shahid Beheshty Blvd.
City
Kermanshah
Postal code
Approval date
2014-06-07, 1393/03/17
Ethics committee reference number
9596
Health conditions studied
1
Description of health condition studied
Perforated acute appendicitis
ICD-10 code
K35.0
ICD-10 code description
Acute appendicitis with perforation
Primary outcomes
1
Description
Wound infection
Timepoint
Daily during hospitalization, one week and three weeks after discharge
Method of measurement
Based on clinical examination
Secondary outcomes
1
Description
Hospitalization time period
Timepoint
At the time of discharge
Method of measurement
Calculating days of hospitalization
2
Description
Wound healing
Timepoint
Three weeks after discharge
Method of measurement
Based on clinical examination
Intervention groups
1
Description
Just a simple dressing is done daily.
Category
Other
2
Description
Surgical wound probing is done only once a day during hospitalization until the wound is impenetrable. Probing is done with a cotton-tipped, sterile dry swab between stitches to depth of external oblique fascia. Simple dressing is applied after wound probing. Swabs are purchased from Bistoon-Teb company and become sterile in Imam Reza Hospital. Cotton-tipped swab contains no antiseptic or antibiotics.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Amir Hosein Parniaei
Street address
Imam Reza Hospital, Parastar Blvd.
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Kermanshah University of Medical Sciences, Building no.2, Shahid Beheshti Blvd.
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah University of Medical Sciences