Surgical IncisionNCT03861065
Secondary Versus Tertiary Wound Closure in High Risk Gynecologic Abdominal Surgical Incisions
A study testing Tertiary Wound Closure and Historical Wound Closure in people with Surgical Incision, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Surgical Incision
- What is being tested?
- Tertiary Wound Closure and Historical Wound Closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2019to 26 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnancy
- Allergy to triclosan
- Patients undergoing HIPEC
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
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.
Read the 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.
- Conditions
- Surgical Incision
- Being tested
- Tertiary Wound Closure, Historical Wound Closure
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tertiary Wound ClosureProcedure or surgery
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.
Historical Wound ClosureProcedure or surgery
Participants wounds are left partially open to heal.
| Study group | Role | What they receive |
|---|---|---|
| Tertiary Wound Closure | Experimental | In the alternative tertiary wound closure, the wound will be partially closed rather than being left open. Sutures in the skin will be placed but not closed. A vacuum assisted closure device will be placed over the wound to help healing. After 4-7 days, the vacuum device will be removed, and the participant's doctor will close the wound. Receives: Procedure: Tertiary Wound Closure |
| Historical Wound Closure | Active comparator | The standard approach to your wound would be to leave it partially open and let it heal over a period of 3-6 months ("secondary closure"). Receives: Procedure: Historical Wound Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Wound Closures Comparing Tertiary Wound Closure Versus Historical Controls Postoperative Day 30
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.
Measured: 30 days after tertiary wound closure
Secondary outcomes (4)
Number of Participants With Surgical Site Infections (SSI) for Tertiary Technique Versus Historical Controls
The number of Surgical Site Infections (SSI) within 30 days using a tertiary closure technique compared to historical controls receiving a secondary would closure.
Measured: 30 days after tertiary wound closure
Length of Hospital Stay
The length of stay as defined by the time from surgery to discharge as compared to historical controls receiving a secondary would closure.
Measured: Up to 3 months after surgery
Proportion of Patients Returning After Surgery
The proportion of patients that return to hospital within 30 days of surgery.
Measured: Up to 30 days after surgery
Quality of Life Questionnaire SF-36 (Version 1)
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.
Measured: Up to 3 months after tertiary wound closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start27 Feb 2019
- Primary completion26 Nov 2020
- Study completion26 Nov 2020
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgical IncisionStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michael G Kelly, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861065
- Sponsor's protocol ID
- IRB00055298
- Other IDs
- NCI-2019-01292, P30CA012197, CCCWFU04418
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2019
- Last updated
- 17 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Versus Tertiary Wound Closure in High Risk Gynecologic Abdominal Surgical Incisions
- ClinicalTrials.gov ID
- NCT03861065
- Acronym / sponsor ID
- IRB00055298
- Conditions
- Surgical Incision
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 26 Nov 2020 (actual)
- Study completion
- 26 Nov 2020 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Posted 17 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tertiary Wound Closure | Experimental | Procedure: Tertiary Wound ClosureIn the alternative tertiary wound closure, the wound will be partially closed rather than being left open. Sutures in the skin will be placed but not closed. A vacuum assisted closure device will be placed over the wound to help healing. After 4-7 days, the vacuum device will be removed, and the participant's doctor will close the wound. |
| Historical Wound Closure | Active comparator | Procedure: Historical Wound ClosureThe standard approach to your wound would be to leave it partially open and let it heal over a period of 3-6 months ("secondary closure"). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy
- Allergy to triclosan
- Patients undergoing HIPEC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tertiary Wound ClosureThe 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. | Procedure or surgery | Tertiary Wound Closure |
| Historical Wound ClosureParticipants wounds are left partially open to heal. | Procedure or surgery | Historical Wound Closure |
Primary outcome
Number of Participants With Wound Closures Comparing Tertiary Wound Closure Versus Historical Controls Postoperative Day 30
Time frame: 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.
4 secondary outcomes
Number of Participants With Surgical Site Infections (SSI) for Tertiary Technique Versus Historical Controls
Time frame: 30 days after tertiary wound closure
Length of Hospital Stay
Time frame: Up to 3 months after surgery
Proportion of Patients Returning After Surgery
Time frame: Up to 30 days after surgery
Quality of Life Questionnaire SF-36 (Version 1)
Time frame: Up to 3 months after tertiary wound closure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael G Kelly, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tertiary Wound Closure and Historical Wound Closure in people with Surgical Incision, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Wound Closures Comparing Tertiary Wound Closure Versus Historical Controls Postoperative Day 30 (time frame: 30 days after tertiary wound closure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.