The current study aimed to compare subcuticular and semi-mattress appendectomy wound suturing methods in terms of pain, wound complications, scar width and patients’ satisfaction to introduce a more suitable method.
Design
Randomized clinical trial with parallel groups without blinding which will be conducted on 50 patients undergoing appendectomy.
Settings and conduct
This parallel RCT (phase III) study will be conducted at Imam Sajjad Hospital of Ramsar from September 2019 to March 2020. 50 patients in two groups of 25 will be enrolled. Included patients are diagnosed with acute appendicitis by a surgeon and treated with open appendectomy. Patients will be assigned into two groups; intervention group A undergoing subcuticular suture and intervention group B undergoing semi-matress suture. Patients are randomized in block of 5 patients. Follow-up will take place on 3rd, 7th and 30 days after surgery by a surgeon. Patients will be evaluated for pain severity, and aesthetic outcome by Visual Analog Scale (VAS). Surgical site infection, scar width and other complications will be evaluated by direct observation. Subsequently groups will be compared with each other. With respect to nature of the study blinding is not done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Acute uncomplicated appendicitis, Informed consent
Exclusion criteria: Immunodeficiency, Age > 18 years and BMI<30 kg/m2
Intervention groups
Each group receives different suturing technique for their surgical wound. One group is treated with non-absorbable subcuticular sutures and other group will receive semi-mattress sutures
Main outcome variables
Width of surgical scar a month after appendectomy; Aesthetic VAS score one month after surgical intervention; Prevalence of surgical site and suturing complications on 3rd, 7th and 30 days after appendectomy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190813044523N1
Registration date:2019-09-06, 1398/06/15
Registration timing:prospective
Last update:2019-09-06, 1398/06/15
Update count:0
Registration date
2019-09-06, 1398/06/15
Registrant information
Name
Mohammad Hadizadeh Neisanghalb
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 5522 2031
Email address
h.of.mohammad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Subcuticular and Semi-matress Suture Size and Complications in Appendectomy Surgical Scar
Public title
Comparison of Two Suturing Methods in Appendectomy Repairs
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Uncomplicated acute appendicitis
Informed consent
Exclusion criteria:
Immunodeficiency
BMI<30 kg/m2
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with blocks of 5 Considering the sample size of 50, 10 blocks with 20 cards (10 cards for each group) will be selected; by selecting each block, 5 patients will be assigned into each group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committe of Ramsar Campus- Mazandaran University of Medical Sciences
Street address
Taleghani St, Taleghani 20 Alley
City
Ramsar
Province
Mazandaran
Postal code
4691786953
Approval date
2019-05-20, 1398/02/30
Ethics committee reference number
IR.MAZUMS.RIB.REC.1398.004
Health conditions studied
1
Description of health condition studied
Acute appendicitis
ICD-10 code
K35
ICD-10 code description
Acute appendicitis
Primary outcomes
1
Description
Width of scar
Timepoint
One month after surgical intervention
Method of measurement
Ruler
2
Description
Aesthetic of surgical scar
Timepoint
One month after surgical intervention
Method of measurement
VAS (visual analog scale)
3
Description
Wound dehiscence
Timepoint
3rd, 7th and month after surgical intervention
Method of measurement
Physical examination by physician
4
Description
Pain at surgical site
Timepoint
3rd and 7th day after surgical intervention
Method of measurement
VAS (visual analog scale)
5
Description
Wound infection
Timepoint
3rd and 7th day after surgical intervention
Method of measurement
Physical examination by physician
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A (Subcuticular suture): In this group of patients, after appendectomy, the subcutaneous tissue is repaired with absorbable stitches and then, the skin is going to be sutured subcutaneously with 3-0 nylon stitches. In subcuticular suturing method, needle is introduced in beginning of the wound then its run through subcuticular layer of skin. In the end needle exits through the end of the wound.
Category
Treatment - Surgery
2
Description
Intervention group B (Semi-matress suture): In this group of patients, after appendectomy, subcutaneous tissue is repaired with absorbable stitches and then, the skin is sutured with semi-mattress technique with 3-0 nylon stitches. Semi-mattress suturing method is a variant of Vertical mattress sutures, In Semi-mattress method, needle is introduced through edge of the wound then it is run through subdermal layers and after passing through subcuticular layer of the opposite edge, needle exits on the same side of introduction. each suture is done separately.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Sajjad Hospital of Ramsar
Full name of responsible person
Mohammad Hadizadeh Neisanghalb
Street address
Enghelab sq.
City
Ramsar
Province
Mazandaran
Postal code
4691786953
Phone
+98 11 5522 2031
Email
h.of.mohammad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ramsar Campus - Mazandaran University of Medical Sciences
Full name of responsible person
Davood Farzin
Street address
Taleghani St.
City
Ramsar
Province
Mazandaran
Postal code
4691786953
Phone
+98 11 5522 6108
Email
d.farzin@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ramsar Campus - Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ramsar Campus - Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Hadizadeh Neisanghalb
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Taleghani St, Taleghani 20th St.
City
Ramsar
Province
Mazandaran
Postal code
4691786953
Phone
+98 11 5522 6108
Email
h.of.mohammad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ramsar Campus - Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Hadizadeh Neisanghalb
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Taleghani St, Taleghani 20th St.
City
Ramsar
Province
Mazandaran
Postal code
4691786953
Phone
+98 11 5522 6108
Email
h.of.mohammad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ramsar Campus - Mazandaran University of Medical Sciences
Full name of responsible person
Mohammad Hadizadeh Neisanghalb
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Taleghani St.
City
Ramsar
Province
Mazandaran
Postal code
4691786953
Phone
+98 11 5522 6108
Email
h.of.mohammad@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
all collected deidentified data for primary and secondary outcome measures are going to be shared
When the data will become available and for how long
after publishing the study, data are going to be available
To whom data/document is available
data are going to be available to all researchers and clinician irrespective to their employment sector
Under which criteria data/document could be used
permission are granted upon request for secondary and meta-analysis
From where data/document is obtainable
requests are gathered through principle researcher's e-mail address
What processes are involved for a request to access data/document
upon verification of request and reason data are given in three month.