CTRI

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CTRI Number

CTRI/2024/03/063767 [Registered on: 07/03/2024] Trial Registered Prospectively

Last Modified On:

11/09/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Surgical/Anesthesia

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Comparing Skin Closure Techniques: Sutures versus Staples at Tezpur Medical College and Hospital

Scientific Title of Study

A comparative study of outcome of skin closure with conventional sutures versus staples at Tezpur Medical College and Hospital

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Tapash Kumar Kalita
Designation	Postgraduate trainee
Affiliation	Tezpur Medical College and Hospital
Address	Room No 5 Department of General Surgery Tezpur Medical College and Hospital Tezpur Sonitpur Assam Sonitpur ASSAM 784010 India
Phone	8876462391
Fax
Email	mytapash88@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Nirmal Kumar Agarwal
Designation	Associate Professor
Affiliation	Tezpur Medical College and Hospital
Address	Room 8 First Floor Department of General Surgery Tezpur Medical College and Hospital Tezpur Sonitpur ASSAM 784010 India
Phone	9864097914
Fax
Email	nksurgeon@gmail.com

Details of Contact Person
Public Query

Name	Dr Tapash Kumar Kalita
Designation	Postgraduate trainee
Affiliation	Tezpur Medical College and Hospital
Address	Room No 5 Department of General Surgery Tezpur Medical College and Hospital Tezpur Sonitpur Assam Sonitpur ASSAM 784010 India
Phone	8876462391
Fax
Email	mytapash88@gmail.com

Source of Monetary or Material Support

Tezpur Medical College and Hospital Tezpur Sonitpur Assam

Primary Sponsor

Name	Dr Tapash Kumar Kalita
Address	Tezpur Medical College and Hospital Tezpur Sonitpur Assam
Type of Sponsor	Other [Self]

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
Dr Tapash Kumar Kalita	Tezpur Medical College and Hospital	General Surgery Ward Second and Third floor Department of General Surgery Tezpur Medical College and Hospital Tezpur Sonitpur ASSAM	8876462391 mytapash88@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Human Ethical Committee Tezpur Medical College and Hospital	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type

Condition

Patients

(1) ICD-10 Condition: K35||Acute appendicitis, (2) ICD-10 Condition: K811||Chronic cholecystitis, (3) ICD-10 Condition: K265||Chronic or unspecified duodenal ulcer with perforation, (4) ICD-10 Condition: K565||Intestinal adhesions [bands] withobstruction (postinfection), (5) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Skin Stapler	Subcutaneous sutures will be used on each patient to reduce stress, close dead space, and align wounds. The skin incision will then be sealed using skin staples. After one week, one month, and three months, the wound will be assessed. The relevant information will be gathered and documented about the patients.
Intervention	Suture	Subcutaneous sutures will be used on each patient to reduce stress, close dead space, and align wounds. The skin incision will then be sealed using a nonabsorbable suture. After one week, one month, and three months, the wound will be assessed. The relevant information will be gathered and documented about the patients.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	Patients in age group between 18-70 years of age Patients of both sexes. Patients who have given informed consent after reviewing the informed consent.

ExclusionCriteria

Details

Psychiatric patients
On table deaths
Immune-compromised states like TB, HIV
Patients having uncontrolled Diabetes
Patients who refused to cooperate for the entire study period
Pregnant women

Method of Generating Random Sequence

Random Number Table

Method of Concealment

On-site computer system

Blinding/Masking

Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
Time taken for suturing Post operative wound infection Pain scoring during suture removal Cost effectiveness Cosmesis	Immediate post procedure One week post procedure Three months post procedure

Secondary Outcome

Outcome	TimePoints
Complications Ease of use Functional outcome	Immediate post procedure One week post procedure Three months post procedure

Target Sample Size

Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120"

Phase of Trial

Phase 3/ Phase 4

Date of First Enrollment (India)

01/04/2024

Date of Study Completion (India)

31/08/2024

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Completed

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

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

Response - YES

What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identiﬁcation (text, tables, ﬁgures, and appendices).

What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identiﬁed for this purpose.

For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.

By what mechanism will data be made available?
Response - Proposals should be directed to [mytapash88@gmail.com].

For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2030?
Response - Beginning 3 months and ending 5 years following article publication.

Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL

Brief Summary
Modification(s)

Title of the Thesis	A comparative study of outcome of skin closure with conventional sutures versus staples at Tezpur Medical College & Hospital
Background	A variety of techniques and materials are available these days for wound apposition. Ideally, wound closure technique should provide skin apposition till healing occurs, prevent wound infection, provide equal strength throughout the length of the incision, have a good cosmetic result and should be easy and comfortable to use. Application of suture is the technique of choice for apposition of skin edges in surgical wounds. The same procedure performed with application of staplers is said to be faster and produce better cosmetic outcomes. So, its important to compare the conventional and stapler suturing techniques in terms of the above parameters.
Aims and Objectives	To study the relevant advantages & disadvantages offered by the skin stapler over the conventional skin suturing techniques.
Materials and Methods with brief mention of sample size data collection procedure.	Study will be conducted in the Department of GENERAL SURGERY, TMCH for one year . Sample size will be taken as calculated by standard statistical formula.
Result and Analysis	The results will be statistically analyzed and presented in graphical, tabular and textual form
Probable Hypothesis and Conclusion	To prove that the incidence of wound infection, pain score, time taken for suturing are lesser in stapler group compared to conventional sutures.
Source of fund	Self