Antithrombotics and Complications in Skin Grafts

Complications in Skin Grafts When Continuing Antithrombotic Therapy Prior to Cutaneous Surgery Requiring Skin Grafting: an Observational Study

Patients who were referred to cutaneous surgery and needed full thickness or split skin grafting and using antitrombotic or non-antitrombotic therapies were observed. Data on patient characteristics, diagnosis, location of surgery and surgery performed, antithrombotic medication and complications in skin grafts were collected. Skin grafts were traced on a transparent film and areas of unhealed skin graft were marked

Study Overview

• Status: Completed
• Conditions: Skin Graft Complications

Detailed Description

Use of anticoagulants is common and practice regarding continuation or discontinuation of the medication peri-operatively for cutaneous surgery lacks evidence-based consensus. Therefore, patients who were referred to cutaneous surgery and needed full thickness or split skin grafting and using antitrombotic or non-antitrombotic therapies were observed. Data on patient characteristics, diagnosis, location of surgery and surgery performed, antithrombotic medication and complications in skin grafts were collected. Skin grafts were traced on a transparent film and areas of unhealed skin graft were marked

• Study Type: Observational
• Enrollment (Actual): 172

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A total of 172 patients (92 males and 80 females) having 187 skin grafts were included. Avarage size of the skin grafts were 1278 mm2 ranging from 52mm2 to 14283mm2. Skin grafts where the patients received no or paused antithrombotic treatment were 90 while 97 skin grafts belonged to patients in antithrombotic treatment

Description

Inclusion Criteria:

Patients referred to cutanous surgery with full thickness or split skin grafting. The excision should be performed on the levels of subcutis or perichondrium -

Exclusion Criteria:

Patients having a pacemaker, needed skin graft on bare bone and patients with an INR above 3.5

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Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative bleeding	5-7 postoperative day

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Investigators: Principal Investigator: Lene Birk-Sørensen, PhD, Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: January 14, 2020
• First Submitted That Met QC Criteria: January 14, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2019-29-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No