Protocol summary

Study aim
comparison of nylon and Monocryl sutures in joint replacement surgery in terms of wound healing, complication rates (infection, inflammation, and bleeding), and patient satisfaction.
Design
A prospective, randomized, double-blind, parallel-group clinical trial will be conducted in 100 patients. Patients will be randomized in a 1:1 ratio to nylon or Monocryl skin suture groups using variable block sizes of 4 and 6 through the Sealed Envelope online randomization system.
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 hip replacement surgery. Age between 18 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
After completion of the joint replacement surgery, the skin will be closed with nylon sutures in one group and with Monocryl sutures in the other group.
Main outcome variables
Wound pain intensity, Wound cosmetics, POSAS (Patient and Observer Scar Assessment Scale), Wound complications, Wound healing time

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200305046700N19
Registration date: 2026-10-10, 1405/07/18
Registration timing: prospective

Last update: 2026-10-10, 1405/07/18
Update count: 0
Registration date
2026-10-10, 1405/07/18
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
2026-11-06, 1405/08/15
Expected recruitment end date
2027-06-22, 1406/04/01
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 Hip Arthroplasty: A Randomized Clinical Trial
Public title
Comparison of Nylon and Monocryl Sutures for Skin Closure Following Hip Arthroplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients requiring hip replacement surgery, aged 18 to 85 years, confirmation of patient awareness regarding the study and provision of informed consent.
Exclusion criteria:
Patients with a history of prior surgery in the target joint area patients with inflammatory joint diseases patients who smoke or consume alcohol patients with hypoalbuminemia or severe anemia patients unable to provide informed consent
Age
From 18 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
Patients will be randomly allocated in a 1:1 ratio to either the nylon or Monocryl suture group. 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 be blinded to the type of suture used and will not be informed of their group allocation. On the day of surgery, the patient’s group allocation will be communicated to the surgeon by the study secretary. Postoperative data from patients in groups A and B will be collected and recorded by the study assistants. The data will be coded without identifying the suture type or treatment group and will subsequently be provided to the data analyst. The analyst will remain blinded to group allocation and suture type until completion of the statistical analysis.
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.1405.142

Health conditions studied

1

Description of health condition studied
Total Hip 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 numerical scale ranging from 0 to 10, on which the patient self-reports the intensity of pain.

Secondary outcomes

1

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.

2

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

3

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.

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
Intervention group: 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

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
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 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 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 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

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
There is not a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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