Absorbable or Non Absorbable Sutures in Hand Surgery

NCT04812275 | Completed

• 1 other identifier: 2020-06004
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wound Complication Hand Surgery

Outcome Measures

Primary Outcomes (1)

• Infection

  Signs of superficial infection after surgery. Redness, pus, swelling.

  2 weeks

Secondary Outcomes (3)

• Rupture

  2 weeks

• VAS

  2 weeks

• Time

  2 weeks

Study Arms (2)

Non absorbable suture

ACTIVE COMPARATOR

Wound closure with non absorbale suture. Dimension and brand at the discretion of the surgeon.

Procedure: Skin closure

Absorbable suture

EXPERIMENTAL

Wound closure with absorbale suture. Dimension and brand at the discretion of the surgeon.

Procedure: Skin closure

Interventions

Skin closure PROCEDURE

Skin closure

Absorbable suture; Non absorbable suture

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Department of Hand surgery Södersjukhuset: lead

Study Sites (1)

Södersjukhuset Hospital

Stockholm, 118 83, Sweden

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 23, 2021
• Study Start: April 19, 2021
• Primary Completion: November 10, 2023
• Study Completion: November 11, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)