Wound Closure After Total Knee Arthroplasty: Comparison of Polypropylene and Polyglactin 910 Suture. A Randomised Controlled Trial.
Phase: NA
Conditions: Wound Heal, Wound Dehiscence, Wound Complication
Sponsor: Indus Hospital and Health Network

Cover Page 
 
WOUND CLOSURE AFTER TOTAL KNEE ARTHROPLASTY: COMPARISON OF 
POLYPROPYLENE AND POLYGLACTIN 910 SUTURE-A RANDOMISED 
CONTROLLED TRIAL 
 
NCT no not yet assigned  
 
Date: 04/02/2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

MATERIALS AND METHODS: 
The present parallel randomized controlled trial was conducted to compare the outcomes of 
wound closure using polypropylene versus subcuticular polyglactin 910 sutures in patients 
undergoing total knee arthroplasty (TKA).  
Ethical approval:  
Approval for the Indus Hospital and Health Network institutional review board was obtained 
beforehand. (IRB# 2021_10_004 ) 
Patient selection:   
All patients aged 50-80 years, belonging to either sex, diagnosed with end-stage osteoarthritis or 
post-traumatic arthritis, and scheduled for bilateral primary total knee arthroplasty at the 
Department of Orthopedics, Indus Hospital and Health Network, Karachi were enrolled in the 
study. Exclusion criteria included patients having existing skin, neuromuscular, or connective 
tissue disorders, rheumatoid arthritis, immunosuppression, morbid obesity, and pregnancy. All 
patients provided voluntary informed written consent before enrolment in the study.  
Intervention: 
In all patients undergoing primary TKA, one knee was closed using polypropylene, whereas the 
other was closed with Polyglactin 910 sutures. All surgeries were performed by the same 
surgical team using a standard medial parapatellar approach. The number of sutures and wound 
closure techniques were standardized across both groups.  
Outcomes: 
Wound healing was then assessed in the postoperative period at regular intervals (days +3, +7, 
+15, and +30). Wound-related complications such as surgical site infection (SSI), dehiscence, 
delayed healing, and Hollander score were recorded. Patient-related outcomes such as pain levels 
and satisfaction with wound healing were also assessed.  
Randomization: 
The patients were randomized assigned into two groups. The samples were allocated into two 
groups by a simple randomization technique using computer generated random numbers. The 

choice of procedure was determined based on whether the number fell into either group A or B. 
Group A had wound closure via polypropylene suture while Group B with polyglactin 910. 
Statistical analysis: 
Data analysis was performed using SPSS version 24.0. After assessing the normality of the data, 
all continuous variables were represented as medians (IQR). Discrete variables are shown as 
frequencies and percentages. The Hollander score prediction model was used to evaluate the 
correlation between the Hollander score and all independent variables. Statistical significance 
was set at P < 0.05. 
Results:  
A total of forty patients were enrolled in this study. There was a female predominance in the 
present study, with a M:F ratio of 1:2.07 (Table 1). The median (IQR) age of the study 
participants was 58 years (50.5 - 69.0 years). Hypertension was the most frequent comorbidity 
[33(82.5 %)], followed by diabetes mellitus [15 (37.5%)].  
At baseline, ASA of Anesthesiologists grade II was the most frequently observed class in the 
study cohort (85%). The complications and the Hollander score of the patients as observed in the 
two suture groups are displayed in Table 2. Presentation of erythema was observed in more 
patients in the polypropylene group versus polyglactin 910 group for postoperative days 3, and 7 
i.e. 21 versus 16, and 14 versus 12 respectively but then became vice versa for days 15, and 30 
during which the polyglactin 910 group had more patients i.e. 5 versus 3 and 2 versus 0 
respectively. The polyglactin 910 group had a higher number of patients in comparison to the 
polypropylene group for parameters such as wound dehiscence (3 versus 0), wound discharge 
(24 versus 16), blisters (3 versus 2), stitch abscess (3 versus 1), >1 cm of cellulitis (16 versus 
12), step-off border (17 versus 15), >2mm width scar (10 versus 9), and suture removal due to 
infection (3 versus 1). The polyglactin 910 group also had a higher of patients with systemic 
symptoms compared to the polypropylene group (7 versus 4). Poor overall cosmesis was 
observed in an equal number of patients in both suture groups i.e. 8 (20%). The median 
Hollander score in both suture groups was reported to be 6. In terms of the correlation 
coefficient, age [-0.076 (0.042)], weight [-0.121 (0.047)], and presence of diabetes mellitus [-

1.335 (0.741)] had a positive while height [0.095 (0.045)] had a negative correlation on the 
prediction of Hollander score 

 
IRB Number: IHHN_IRB_2021_10_004 
PI Name: Nek Mohammad 
PI version: v1, Oct 2021 
 
 
CONSENT FORM  
Study Title:  Wound closure after Total knee Arthroplasty: comparison between polypropylene and 
                       polyglactin 910 sutures 
 
What you should know about the study: 
• 
You are being asked to join a research study. 
• 
This consent form explains the research study and your part in the study. 
• 
You are a volunteer. You have the right to choose whether to participate or not participate in this study. If 
you decide to participate and later change your mind, you may do so without any penalty or 
consequences to your treatment here. 
Purpose of research project: 
To compare the wound healing in patient undergone Total Knee Arthroplasty, comparison between non-
absorbable polypropylene and absorbable polyglactin 910. Currently in our setup we are using 
polypropylene for the wound closure and facing wound complication and prolong hospital stay of the 
patient. So with this study if we found polyglactin is superior then the polypropylene then we can switched 
to polyglactin for wound closure. We will be enrolled 60 participants in this study 30 in each group.  
What you will be asked to do in this study 
If you are agreed for this research, then you will be placed in one of the two groups.  
Group A: wound closed with Non-absorbable polypropylene which is routine at The Indus hospital 
Group B: wound closed with absorbable polyglactin 910.  
 
Privacy: We assure you that your research information will be kept secret. We will use ID numbers 
instead of your name. Your name will not be given to anyone without your consent.  Your doctor, 
researchers from Indus Hospital will be able to look at your medical records.  It is possible that research 
papers may be published for scientific purposes; however, your name nor that of any other participant will 
not be used. 
Risks and Discomfort: 
No risk involved as it is a post-operative wound status comparison study of two different sutures. 
Benefits:  
If by doing this study if we found Non-absorbable polyglactin 910 has good result, then it will be beneficial 
for future patients undergone total knee arthroplasty. 
Alternatives:  
You have the choice of not being part of the study. 
What happen if you choose not to be part of the study? 

 
IRB Number: IHHN_IRB_2021_10_004 
PI Name: Nek Mohammad 
PI version: v1, Oct 2021 
 
 
If you decide not to participate in this research, your operation at the hospital will continue as usual.  Even 
after signing this consent form, you may stop participating at any time. 
Cost of taking part in research: You do not have to pay for taking part in this study.  
 
Payment for taking part in research: You will not get money to be part of this study.  
 
Who do I call if have questions or problem? 
If you have questions about this research, you can contact Dr. Nek Mohammad He can be contacted at 
The Indus Hospital, (Mobile 03153454744) 
 
If you have questions about your rights in a research study as a volunteer, call or contact the Interactive 
Research & Development-IRB office between office hours on Monday to Friday 9am – 5pm at the Indus 
Hospital (Mobile 0300 827 2693) 
 
SIGNATURES 
If you agree to participate in this study, please sign this form. You will receive a copy of this form. 
 
 
 
Sign of study volunteer/participant: _____________________________ Date:___________________ 
 
 
Sign of person taking consent: _____________________________          Date: _________________