NCT03861065

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

February 27, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2020

Completed
5.4 years until next milestone

Results Posted

Study results publicly available

April 17, 2026

Completed
Last Updated

April 17, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

February 25, 2019

Results QC Date

February 19, 2026

Last Update Submit

March 30, 2026

Conditions

Surgical Incision

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 days after tertiary wound closure

Secondary Outcomes (4)

  • Number of Participants With Surgical Site Infections (SSI) for Tertiary Technique Versus Historical Controls

    30 days after tertiary wound closure

  • Length of Hospital Stay

    Up to 3 months after surgery

  • Proportion of Patients Returning After Surgery

    Up to 30 days after surgery

  • Quality of Life Questionnaire SF-36 (Version 1)

    Up to 3 months after tertiary wound closure

Study Arms (2)

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.

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").

Procedure: Historical Wound Closure

Interventions

Tertiary Wound ClosurePROCEDURE

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.

Tertiary Wound Closure
Historical Wound ClosurePROCEDURE

Participants wounds are left partially open to heal.

Historical Wound Closure

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Allergy to triclosan
  • Patients undergoing HIPEC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Results Point of Contact

Title
Study Nurse
Organization
Wake Forest Baptist Comprehensive Cancer Center
arcarrol@wakehealth.edu
336-713-3539

Study Officials

  • Michael G Kelly, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2019

First Posted

March 4, 2019

Study Start

February 27, 2019

Primary Completion

November 26, 2020

Study Completion

November 26, 2020

Last Updated

April 17, 2026

Results First Posted

April 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)