Wound Infection Clinical Trial
Verified date | July 2007 |
Source | Sundsvall Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Regional Ethical Review Board |
Study type | Interventional |
The purpose of this study is to determine whether a technique using very small stitches when closing a midline incision can reduce the risk for wound complications such as incisional hernia, infection or dehiscence.
Status | Completed |
Enrollment | 737 |
Est. completion date | July 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Male or female patient with an acute or planned operation trough a midline incision at the Surgical Department in Sundsvall, Sweden Exclusion Criteria: - Age under 18 - Previous surgery through a midline incision - Scars from previous surgery crossing the midline - Preexisting hernia in the midline (umbilical, epigastric) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Sweden | Sundsvall Hospital | 851 86 Sundsvall |
Lead Sponsor | Collaborator |
---|---|
Sundsvall Hospital |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of wound infection | Within the first 30 days after surgery | ||
Primary | Frequency of incisional hernia | One year after surgery | ||
Secondary | Frequency of wound dehiscence | Within the first 10 days after surgery | ||
Secondary | Effect of different suture techniques on wound complications related to patient characteristics such as age, BMI, sex etc. and operative characteristics such as emergency surgery, type of surgery, degree of contamination, surgeon,etc.. | Within 1 year. |
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