Surgical Incision
Conditions
Brief summary
The purpose of this research study is to determine if closing a surgical wound differently is better than the procedure that is currently used. The wound will be closed with what is considered "tertiary intent." This means, rather than leaving the wound open, the wound will be partially closed after surgery, and then completely closed 4-7 days after surgery. The investigators also want to see how this new wound closure process affects your quality of life.
Detailed description
Primary Objective To compare the percentage of patients whose wound remained closed on postoperative day #30 after tertiary closure compared to historical controls who underwent secondary would closure. We are primarily looking at time to wound closure. We will be able to abstract this information from the postoperative clinic visit notes from patients in the "historical control" cohort. We will identify 20 patients with characteristics described in the inclusion criteria of this study who underwent laparotomy with secondary would closure during the calendar year 2018. Secondary Objectives To compare the proportion of acute and chronic wound infection in wounds closed with a tertiary closure technique to historical controls receiving a secondary wound closure. To compare the length of stay of patients receiving a tertiary wound closure to historical controls receiving a secondary wound closure. To describe the number of patients receiving a tertiary wound closure that return within 30 days of surgery as compared to historical controls receiving a secondary wound closure. To describe the quality of life in patients receiving a tertiary wound closure.
Interventions
PROCEDURETertiary Wound Closure
The wound will be closed with what is considered tertiary wound closure. This means, rather than leaving the wound open, the wound will be partially closed after surgery, and then completely closed 4-7 days after surgery.
PROCEDUREHistorical Wound Closure
Participants wounds are left partially open to heal.
Sponsors
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with high risk class II, class III, class IV abdominal wounds * Undergoing laparotomy for gynecologic related disorders * Patients undergoing laparotomy for both benign and malignant diagnoses will be included in this study
Exclusion criteria
* Pregnancy * Allergy to triclosan * Patients undergoing HIPEC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Wound Closures Comparing Tertiary Wound Closure Versus Historical Controls Postoperative Day 30 | 30 days after tertiary wound closure | The number of surgical wounds that remained closed at postoperative day #30 after tertiary wound closure as compared to historical controls receiving a secondary wound closure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Surgical Site Infections (SSI) for Tertiary Technique Versus Historical Controls | 30 days after tertiary wound closure | The number of Surgical Site Infections (SSI) within 30 days using a tertiary closure technique compared to historical controls receiving a secondary would closure. |
| Length of Hospital Stay | Up to 3 months after surgery | The length of stay as defined by the time from surgery to discharge as compared to historical controls receiving a secondary would closure. |
| Proportion of Patients Returning After Surgery | Up to 30 days after surgery | The proportion of patients that return to hospital within 30 days of surgery. |
| Quality of Life Questionnaire SF-36 (Version 1) | Up to 3 months after tertiary wound closure | The quality of life is estimated only in patients receiving a tertiary wound closure. Groups of questions were transformed into a 0-100 scale for eight domains. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichael G Kelly, MD
Wake Forest University Health Sciences
Participant flow
Recruitment details
The study enrolled patients to receive tertiary wound closure; historical controls who received secondary wound closure during 2018 were selected for comparison. Historical Controls were not considered enrolled and were only used for comparison.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 57.32 years STANDARD_DEVIATION 13.8 |
| Race/Ethnicity, Customized African American | 3 Participants |
| Race/Ethnicity, Customized Caucasian | 7 Participants |
| Race/Ethnicity, Customized Hispanic | 4 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 5 |
| other Total, other adverse events | 5 / 5 |
| serious Total, serious adverse events | 2 / 5 |
Outcome results
None listed