A Randomized Study Comparing Closed-Incision Negative-Pressure Wound Therapy with Standard Care in Immediate Breast Reconstruction : Plastic and Reconstructive Surgery

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A Randomized Study Comparing Closed-Incision Negative-Pressure Wound Therapy with Standard Care in Immediate Breast Reconstruction

Pieszko, Karolina MD, PhD1,3,4; Pieszko, Konrad MD, PhD2; Wichtowski, Mateusz MD, PhD5; Cieśla, Sławomir MD, PhD1; Ławnicka, Agnieszka MD1; Jamont, Robert MD3; Boyd, J. Brian MD4; Murawa, Dawid MD, PhD1,5

Author Information

Zielona Gora, Nowa Sol, and Poznan, Poland; and Los Angeles, CA

From the 1Clinic of General Surgery and Surgical Oncology

2Faculty of Medicine and Health Sciences, University of Zielona Gora

3Department of Plastic Surgery and Burns, Hospital in Nowa Sol

4Department of Surgery, Division of Plastic Surgery, Harbor-UCLA Medical Center

5Surgical Oncology Clinic, Karol Marcinkowski University of Medical Sciences.

Received for publication September 1, 2021; accepted May 23, 2022.

This trial is registered under the name “Closed Incision Negative Pressure Wound Therapy in Immediate Postmastectomy Breast Reconstruction,” ClinicalTrials.gov identification no. NCT04808765 (https://clinicaltrials.gov/ct2/show/NCT04808765).

Presented at the International Society of Aesthetic Plastic Surgery (ISAPS) World Congress, in Vienna, Austria, September 11 through 13, 2021.

Disclosure statements are at the end of this article, following the correspondence information.

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Karolina Pieszko, MD, PhD, Zyty 26, 65-190 Zielona Gora, Poland, [email protected]

Plastic and Reconstructive Surgery 151(6):p 1123-1133, June 2023. | DOI: 10.1097/PRS.0000000000010110

Abstract

Background: 

Breast cancer remains the most common nonskin cancer among women. Prophylactic methods for reducing surgical-site complications after immediate breast reconstruction (IBR) are crucial to prevent acellular dermal matrices or prosthesis exposure and loss. The authors assessed the impact of closed-incision negative-pressure wound therapy (ciNPWT) versus standard dressings (ST) after IBR on surgical-site complications, superficial skin temperature (SST), skin elasticity, and subjective scar quality, to determine the potential benefit of prophylactic ciNPWT application.

Methods: 

A multicenter randomized controlled study of 60 adult female patients was conducted between January of 2019 and July of 2021. All patients had oncologic indications for IBR using implants or expanders.

Results: 

Application of ciNPWT correlated with a significant decrease in surgical-site complications within 1 year of surgery (total, 40%; ST, 60%; ciNPWT, 20%; P = 0.003) and resulted in more elastic scar tissue as measured with a Cutometer (average coefficient of elasticity, 0.74; ST, 0.7; ciNPWT, 0.9; P < 0.001). The SST of each scar 1 week after surgery was significantly higher in the ciNPWT group (average SST, 31.5; ST SST, 31.2; ciNPWT SST, 32.3; P = 0.006). According to the Patient and Observer Scar Assessment Scale v2.0, subjective scar outcomes in both groups were comparable.

Conclusions: 

This is the first randomized controlled study that demonstrated a significant decrease in surgical-site wound complications within 1 year of surgery in IBR patients receiving ciNPWT. A high probability of postoperative radiotherapy should be a relative indication for the use of ciNPWT. 

CLINICAL QUESTION/LEVEL OF EVIDENCE: 

Therapeutic, II.

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