Comparison of Nylon and Monocryl Sutures for Skin Closure and Their Effects on Wound Healing Outcomes in Patients Undergoing Total Knee Arthroplasty: A Randomized Clinical Trial
Comparison of the Effectiveness of Nylon and Monocryl Sutures for Skin Closure Following Total Knee Arthroplasty: The primary objective of this study will be to compare nylon and Monocryl sutures in joint replacement surgery in terms of wound healing, complication rates (infection, inflammation, and bleeding), and patient satisfaction. Evaluation of the Effect of Nylon and Monocryl Sutures on Wound Healing Time: This study will assess the time required for complete wound healing in the two groups using nylon and Monocryl sutures.
Design
A prospective, randomized, interventional clinical trial involving two groups of patients.
Settings and conduct
At Imam Khomeini Hospital, following completion of joint replacement surgery, the skin will be closed with nylon sutures in one group of patients and with Monocryl sutures in the other group. Routine postoperative wound dressing and care will then be provided.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Patients requiring total knee arthroplasty.
Age between 45 and 85 years.
Confirmation that the patient is aware of the study and has provided informed consent.
Exclusion Criteria:
Patients with a history of previous surgery involving the target joint.
Patients with inflammatory joint diseases.
Patients who smoke or consume alcohol.
Patients with hypoalbuminemia or severe anemia.
Patients who are unable to provide informed consent.
Intervention groups
Group 1 (Nylon Suture): In this group, the wounds will be closed using nylon sutures with interrupted subcutaneous stitches.
Group 2 (Monocryl Suture): In this group, the wounds will be closed using Monocryl sutures with interrupted subcutaneous stitches.
Main outcome variables
Wound pain intensity, Wound cosmetics, Wound complications, Wound healing time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200305046700N20
Registration date:2026-10-21, 1405/07/29
Registration timing:prospective
Last update:2026-10-21, 1405/07/29
Update count:0
Registration date
2026-10-21, 1405/07/29
Registrant information
Name
Mohammadreza Razzaghof
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 0196
Email address
m-razzaghof@razi.tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-11-01, 1405/08/10
Expected recruitment end date
2027-07-01, 1406/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Nylon and Monocryl Sutures for Skin Closure and Their Effects on Wound Healing Outcomes in Patients Undergoing Total Knee Arthroplasty: A Randomized Clinical Trial
Public title
The Comparative Evaluation of Nylon and Monocryl Sutures for Skin Closure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients requiring knee replacement surgery, aged 45 to 85 years
confirmed awareness of the study and provision of informed consent.
Exclusion criteria:
Patients with a history of joint surgery
inflammatory joint diseases
smoking
alcohol consumption
hypoalbuminemia
severe anemia
inability to provide informed consent
Age
From 45 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed using the Sealed Envelope online randomization service. A computer-generated permuted block randomization sequence with variable block sizes of 4 and 6 will be used. The randomization sequence will be generated before recruitment and will not be accessible to investigators responsible for patient enrollment.
For allocation concealment, each assignment will be associated with a sequentially numbered, sealed, opaque card. After confirming eligibility and enrolling the patient, the study secretary will open the next card in sequence and communicate the assigned group to the surgeon immediately before surgery. Thus, the treatment allocation will remain concealed until the patient has been enrolled and randomized.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will not be informed of the type of suture used.
The surgeon will be notified of the patient groups by the secretary on the day of surgery.
Data will be categorized; post-operative data for groups A and B will be collected by assistants.
The analysis remains blinded to the data analyst.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, International Campus, Office of Vice-President for Educational Affairs, Number 25, Hojat Dost St., Felestin St., Keshavarz Blvd., Tehran , Iran.
City
Tehran
Province
Tehran
Postal code
1416634793
Approval date
2026-06-02, 1405/03/12
Ethics committee reference number
IR.TUMS.IKHC.REC.1405.143
Health conditions studied
1
Description of health condition studied
Total knee arthroplasty
ICD-10 code
Z96.6
ICD-10 code description
Presence of orthopedic joint implants
Primary outcomes
1
Description
Wound pain intensity
Timepoint
Days 5 and 14, and weeks 6 and 12, and months 3 and 6 after surgery.
Method of measurement
A visual numerical rating scale ranging from 0 to 10, on which the patient self-reports the intensity of pain.
2
Description
Wound cosmetics
Timepoint
Days 5 and 14, and weeks 6 and 12, and months 3 and 6 after surgery.
Method of measurement
POSAS (Patient and Observer Scar Assessment Scale), assessed by both the patient and the observer.
3
Description
Wound complications
Timepoint
Days 5 and 14, and weeks 6 and 12, and months 3 and 6 after surgery.
Method of measurement
Clinical assessment and reporting by both the patient and the physician.
4
Description
Wound healing time
Timepoint
Days 5 and 14, and weeks 6 and 12, and months 3 and 6 after surgery.
Method of measurement
Assessment of the time required for complete wound healing.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group 1 (Nylon Suture): In this group, the wounds will be closed using nylon sutures with interrupted subcutaneous stitches.
Category
N/A
2
Description
Group 2 (Monocryl Suture): In this group, the wounds will be closed using Monocryl sutures with interrupted subcutaneous stitches.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Seyyed MohammadJavad Mortazavi
Street address
Tehran, at the end of Keshavarz Boulevard, Imam Khomeini Hospital Complex.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir
Web page address
https://ikhc.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Sahraian
Street address
Office of Vice-Chancellor for research, Central Building of Tehran University of Medical Sciences, No. 226, Qods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 8163 3686
Fax
+98 21 8163 3686
Email
vcr@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Razzaghof
Position
Assistant professor of orthopedic surgery
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Tehran, at the end of Keshavarz Boulevard, Imam Khomeini Hospital Complex.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 0196
Email
m-razzaghof@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Razzaghof
Position
Assistant professor of Orthopedics Surgery
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Joint Reconstruction Research Center, Imam Khomeini Hospital Complex, East Baqerkhan Street, North Chamran Highway
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1586
Email
m.razzaghof@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Razzaghof
Position
Assistant professor of orthopedic surgery
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Joint Reconstruction Research Center, Imam Khomeini Hospital Complex, East Baqerkhan Street, North Chamran Highway
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 0196
Fax
Email
m-razzaghof@razi.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD