Absorbable or Non Absorbable Sutures in Hand Surgery

December 14, 2023 updated by: Mirjam Hägg, Department of Hand surgery Södersjukhuset
After all surgical procedures, the skin must be closed with some form of stitch, in healthcare called suture. According to the tradition of hand surgery, sutures that must be removed by caregivers, ie non-resorbable thread, have been used extensively, and the frequency of complications in the form of wound rupture and infection is low. For many procedures, however, it can be an advantage to avoid removing the stitches, as it is both painful for the patient and time-consuming and resource-consuming for both the patient and the healthcare system. You can then use a thread that the body itself breaks down and absorbs, ie resorbable suture. In the project, we will compare resorbable and non-resorbable suture with the primary outcome of superficial infection in the surgical area sometime day 1-20 after surgery. Secondary outcomes are the occurrence of wound rupture, pain VAS (Visual Analog Scale) when changing 2 weeks postoperatively, patient satisfaction VAS at 2 weeks and time spent in minutes for changing at 2 weeks postoperatively. The project will include all consecutive patients> 18 years of age who are operated on at the hand surgery clinic Södersjukhuset for elective or emergency surgery that do not meet the exclusion criteria. The project will include 270 patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 118 83
        • Södersjukhuset Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • all consecutive patients> 18 years of age who are operated on at the hand surgery clinic Södersjukhuset for elective or emergency surgery that do not meet any of the exclusion criteria.

Exclusion Criteria:

  • -The researcher has an age <18 years.
  • Patients with known healing problems in the past, for example patients with burns or during cortisone treatment.
  • Patients undergoing surgery where skin grafting occurs.
  • Patients with acute injuries that include a traumatic wound-ie what is usually referred to as "open injuries" -where the risk of infection is higher from the beginning.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Non absorbable suture
Wound closure with non absorbale suture. Dimension and brand at the discretion of the surgeon.
Procedure: Skin closure
Skin closure
Experimental: Absorbable suture
Wound closure with absorbale suture. Dimension and brand at the discretion of the surgeon.
Procedure: Skin closure
Skin closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infection
Time Frame: 2 weeks
Signs of superficial infection after surgery. Redness, pus, swelling.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rupture
Time Frame: 2 weeks
The prevalens of wound rupture after hand surgery
2 weeks
VAS
Time Frame: 2 weeks
Visual analog scale
2 weeks
Time
Time Frame: 2 weeks
Time consumption removal of sutures
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Department of Hand surgery Södersjukhuset

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2021

Primary Completion (Actual)

November 10, 2023

Study Completion (Actual)

November 11, 2023

Study Registration Dates

First Submitted

February 26, 2021

First Submitted That Met QC Criteria

March 22, 2021

First Posted (Actual)

March 23, 2021

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2020-06004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Wound Complication Hand Surgery

Clinical Trials on Skin closure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ireland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe