Protocol summary

Study aim
Comparison of the Effectiveness of Nylon and Monocryl Sutures for Skin Closure Following Shoulder Replacement Surgery: 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 hemiarthroplasty, anatomic total shoulder arthroplasty, or reverse total shoulder arthroplasty. 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
Comparison of Nylon and Monocryl Sutures for Skin Closure After Shoulder Replacement Surgery
IRCT registration information
IRCT registration number: IRCT20200305046700N18
Registration date: 2026-08-19, 1405/05/28
Registration timing: prospective

Last update: 2026-08-19, 1405/05/28
Update count: 0
Registration date
2026-08-19, 1405/05/28
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
2026-10-02, 1405/07/10
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 Shoulder Arthroplasty: A Randomized Clinical Trial
Public title
Comparison of Nylon and Monocryl Sutures for Skin Closure FollowingShoulder Arthroplasty: A Randomized Clinical Trial, Imam Khomeini HospitalComplex, ۲۰۲۶-۲۰۲۷
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients requiring hemi-shoulder arthroplasty, total shoulder arthroplasty, or reverse shoulder arthroplasty; 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, smokers or patients with alcohol use disorder, patients with hypoalbuminemia or severe anemia, and patients unable to provide informed consent.
Age
From 45 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 126
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to two groups: Group 1 will include patients receiving nylon sutures for skin closure, and Group 2 will include patients receiving Monocryl sutures for skin closure. Randomization will be performed using a digital randomization application. To maintain allocation concealment and minimize selection bias, group assignments will be recorded in sealed opaque cards and will remain concealed until patient enrollment into the study.
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.1405.144

Health conditions studied

1

Description of health condition studied
Shoulder Total 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.

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
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 Moetazavi
Street address
Tehran, at the end of Keshavarz Boulevard, Imam Khomeini Hospital Complex.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1586
Email
smjmort@yahoo.com

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 no further information
Study Protocol
Undecided - It is not yet known if there will be 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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