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CTRI Number  CTRI/2025/11/097038 [Registered on: 07/11/2025] Trial Registered Prospectively
Last Modified On: 30/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing suture thread and skin staplers for skin closure after cesarean delivery 
Scientific Title of Study   Comparison between polyglecaparone 25 suture versus skin stapler for skin closure in Cesarean delivery 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mahendra G 
Designation  Professor and HOD 
Affiliation  Adichunchanagiri Institute of Medical Sciences 
Address  Department of OBG, Adichunchanagiri Institute of Medical Sciences, Nagamangala Taluk, Dist, B.G Nagara, Karnataka

Mandya
KARNATAKA
571448
India 
Phone  9964026610  
Fax    
Email  drmuba@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mahendra G 
Designation  Professor and HOD 
Affiliation  Adichunchanagiri Institute of Medical Sciences 
Address  Department of OBG, Adichunchanagiri Institute of Medical Sciences, Nagamangala Taluk, Dist, B.G Nagara, Karnataka

Mandya
KARNATAKA
571448
India 
Phone  9964026610  
Fax    
Email  drmuba@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mahendra G 
Designation  Professor and HOD 
Affiliation  Adichunchanagiri Institute of Medical Sciences 
Address  Department of OBG, Adichunchanagiri Institute of Medical Sciences, Nagamangala Taluk, Dist, B.G Nagara, Karnataka

Mandya
KARNATAKA
571448
India 
Phone  9964026610  
Fax    
Email  drmuba@gmail.com  
 
Source of Monetary or Material Support  
Adichunchanagiri Institute of Medical Sciences 
 
Primary Sponsor  
Name  Adichunchanagiri Institute of Medical Sciences 
Address  Nagamangala Taluk, Dist, B.G Nagara, Karnataka 571448 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Tejaswini Mudri  Adichunchanagiri Institute of Medical Sciences  Department of OBG, Nagamangala Taluk, Dist, B.G Nagara, Karnataka 571448
Mandya
KARNATAKA 
8123943368

mudritejaswini08@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Adichunchanagiri Institute of Medical Sciences Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z481||Encounter for planned postprocedural wound closure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Poliglecaprone-25 suture  Skin closure using single-layer subcuticular continuous 3-0 , poliglecaprone (Monoglyde) with buried knot technique; no external sutures.  
Intervention  Skin stapler  Skin closure using disposable sterile stainless steel skin stapler (Surgipler Neo) applied as per manufacturers instructions.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Pregnant women aged 18–45 years undergoing LSCS (elective or emergency)
Skin closure planned with single layer subcuticular technique
Able and willing to provide written informed consent and attend follow-up visits 
 
ExclusionCriteria 
Details  Known allergy to suture or staple material
Current systemic infection or immunosuppression (e.g., long-term steroids, chemotherapy)
Known bleeding disorder
Significant obesity where fascial closure or wound management is expected to differ (BMI greater than 40 kg/m²)
Multi-layer disrupted closure or major intraoperative complication requiring re-exploration
Previous lower abdominal surgery with distorted anatomy at incision site 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Incidence of surgical site infection (SSI), defined according to standard criteria (purulent drainage from incision, culture positive wound drainage, or physician diagnosis of superficial/deep incisional SSI requiring antibiotics or wound opening)   Incidence of SSI within 30 days post operation.  
 
Secondary Outcome  
Outcome  TimePoints 
Cosmetic outcome of the scar measured by a validated scale — e.g., Patient and Observer Scar Assessment Scale (POSAS)   Day of discharge, 30 days post operation and 3 months post operation 
Wound-related complications: seroma, hematoma, wound dehiscence/separation (partial/full), suture extrusion, hypertrophic scar/keloid formation  Within 3 months of post operation  
Postoperative pain at incision site (measured by Visual Analogue Scale)  24 hours post operation, 7 days post operation and 30 days post operation 
Time taken for skin closure during Cesarean section   Day of surgery 
Re-admission related to wound complications   within 30 days post operation 
Patient satisfaction with wound healing (Likert scale)  3 months post operatively 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   17/09/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Cesarean sections are the most frequently performed major surgeries in obstetrics and gynecology. There is increase in number of  cesarean sections globally today, and there are several factors that contribute to this including - maternal obesity, an aging maternal population, maternal request for non-medical reasons. These women pass through a period of post operative pain and discomfort. Thus there is a load on the financial resources of  healthcare system. Use of the appropriate technique to approximate the wound after caesarean section would not only avoid financial load but also help in early recovery of the patient.

Five to ten times as many surgical-site infections occur after cesarean birth as after vaginal delivery. Thus the question of reducing infections, quick wound healing and better cosmetic outcome have arisen, hence the need for the hour is to identify and make changes to decrease the rate of wound infection and improve cosmetic outcome. An essential part of cesarean section is skin closure; it affects cosmetic outcomes, patient and surgeon satisfaction, and the existence or absence of wound problems. The goals of wound closure include obliteration of dead space, even distribution of tension along deep suture lines, and maintenance of tensile strength across the wound. Methods used for mechanical wound closure includes staples, tape, adhesives, and sutures. Suture closure permits primary wound healing. 

The optimal skin closure method should be quick, affordable, safe, and successful. It should also cause the least amount of pain to the patient and provide pleasing esthetic results. In addition, there should be less need for postoperative monitoring and a low incidence of wound complications. The process of wound healing is affected by the structural properties and coating of the suture. Using ideal suture material for subcuticular skin closure not only aids in restoring skin functions but also provides cosmesis. Subcuticular suturing is performed just beneath the epidermal layer and is preferred for postcesarean skin approximation as it prevents foreign material from passing through. Subcuticular skin suturing following CS has a reduced incidence of wound issues and aesthetically pleasing outcomes. Poliglecaprone is an absorbable suture, completely absorbed within 90 days of application, with minimal inflammatory reaction. Therefore, this study is designed to compare sub-cuticular skin closure by monoglyde versus skin stapler  

 
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