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Clinical Trials/CTRI/2024/03/063767
CTRI/2024/03/063767Not yet recruitingPhase 3 4

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

Dr Tapash Kumar Kalita1 site in 1 country120 target enrollmentStarted: April 1, 2024Last updated:

Trial Snapshot

Phase
Phase 3 4
Status
Not yet recruiting
Sponsor
Enrollment
120
Locations
1
Primary Endpoint
Time taken for suturing Post operative wound infection Pain scoring during suture removal Cost effectiveness Cosmesis

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Time taken for suturing Post operative wound infection Pain scoring during suture removal Cost effectiveness Cosmesis

Time Frame: Immediate post procedure | One week post procedure | Three months post procedure

Secondary Outcomes

  • Complications(Ease of use)

Investigators

Sponsor
Dr Tapash Kumar Kalita
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Tapash Kumar Kalita

Tezpur Medical College and Hospital

Study Sites (1)

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