| 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
|
|
|
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
|
|
|
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 |