NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT

Breast Cancer Clinical Trial

— NPWTinDIEP  

Official title:

Negative Pressure Wound Therapy for Abdominal Incisions in DIEP Reconstructions: A RCT

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05338281
• Other study ID #: 120134
• Status: Withdrawn
• Phase: N/A
• Start date: September 2023
• Est. completion date: October 2025

Study information

• Verified date: April 2023
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The current study is a single center randomized control trial that will examine the effect of closed incision negative pressure wound therapy (ciNPT) versus conventional dressing on abdominal incision in a deep inferior epigastric perforator (DIEP) flap based reconstruction. Patients will be followed by 30 days post-operatively to compare outcomes including the rate of surgical site infection, seroma, and the scar quality.

Description:

The current study will examine the effect of closed incision negative pressure wound therapy on DIEP flap donor site. A total of 520 patients who are candidates for DIEP flap-based breast reconstruction will be included in this study, and randomly divided into the two groups. Those with contraindications to ciNPT will be excluded. The surgical consultation and procedure will be conducted same for both groups. Patients will be followed by 30 days post-operatively. Outcome measures will include incidence of surgical site infection, wound dehiscence, seroma, hematoma, delayed wound healing, and surgical scar quality.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients who are undergoing either immediate, or delayed reconstruction of the breast following mastectomy
• Patients going either unilateral or bilateral reconstruction

Exclusion Criteria:

• Patients who are not candidates for DIEP flap based breast reconstruction, such as those with insufficient abdominal tissue, or unfit for the surgery will be excluded from this study. -
• Patients who have contraindications to the ciNPT
• Patients who have pre-existing conditions that may confound results such as bleeding disorder or therapeutic anticoagulation will be excluded from the study.
• Patients who do not want to carry an additional canister from the ciNPT during the initial recovery phase will be excluded from the study.

Related Conditions & MeSH terms

• Breast Cancer
• Surgical Site Infection
• Surgical Wound Infection
• Wound Dehiscence

Intervention

Device:
• Negative Pressure Wound Therapy
The negative pressure wound therapy will be placed in addition to usual care of the abdominal donor site, such as closure with resorbable sutures, drain placements.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Western University, Canada	Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Surgical Site Infection (SSI)	The post-operative SSI at the abdomen will be determined following the Center for Disease Control (CDC) criteria. This includes one or more of the following: 1. Purulent drainage from the incision, 2. Organisms identified from an aseptically-obtained specimen 3. Superficial incision with one of the following signs or symptoms localized pain or tenderness; localized swelling; erythema; or heat.; d. Diagnosis of a superficial incisional SSI by a physician or designee	30 days after operation
Secondary	The rate of seroma diagnosis	The diagnosis of seroma will be completed by clinical exam and/or diagnostic imaging such as ultrasound or computed tomography.	30 days after operation
Secondary	The rate of hematoma diagnosis	The diagnosis of hematoma will be completed by clinical exam and/or diagnostic imaging such as ultrasound or computed tomography.	30 days after operation
Secondary	The rate of wound dehiscence	The diagnosis of wound dehiscence will be made by clinical exam.	30 days after operation