The safety of punch biopsies on hard-to-heal wounds: a large multicentre clinical trial

Abstract

Objective: Punch biopsy is a simple and effective diagnostic technique used in hard-to-heal wound management. Histologic examination can rule out cancer in the wound bed or diagnose vasculitis in a hard-to-heal or suspicious ulcer. A biopsy can determine the level of bacteria in an ulcer when infection is suspected. Despite its use, health professionals practicing in wound clinics hesitate to perform punch biopsies. The reasons vary from the invasive nature of the procedure to a fear of complications. Methods: A multicentre clinical trial evaluated the addition of fluorescence imaging to clinical examination in determining bacterial burden in hard-to-heal wounds. The protocol required a 6mm punch biopsy of any area (up to three) suspected of having moderate-to-high bacteria levels either on clinical examination or fluorescence image. If clinical examination and fluorescence imaging both did not indicate bacteria, the health professional took a biopsy of the centre of the ulcer. The biopsies were performed under local anaesthesia after cleansing the ulcer bed with sterile normal saline. Haemostasis was achieved with direct pressure and the occasional topical clotting agent. All of the patients were followed for 30 days to monitor for adverse events. Results: A total of 350 patientis with wounds (diabetic foot ulcer n=138; venous leg ulcer n=106; pressure ulcer n=22; surgical site infection n=60; other n=24), enrolled by 20 investigators at 14 sites in the US, underwent a total of 412 punch biopsies. Haemostasis was achieved in all 412 biopsies. No biopsy sites required cautery or suture ligation to control bleeding. No subjects returned to the clinic secondary to bleeding. A patient developed an infection three days post-biopsy that could have been due to the punch biopsy. However, the patient was HIV-positive and the quantitative biopsy was positive for infection, biopsy bacterial load of 106 colony forming units (CFU)/g. Conclusion: This trial used a 6mm punch to obtain tissue for culture, histology and additional biomarker research. In daily wound care practice, a smaller 3mm punch suffices. Adverse events were rare despite the larger biopsy. Punch biopsies are a safe procedure for obtaining tissue for histologic or microbiologic analysis.

Diagnostic Accuracy of Point-of-Care Fluorescence Imaging for the Detection of Bacterial Burden in Wounds: Results from the 350-Patient Fluorescence Imaging Assessment and Guidance Trial

“…No serious adverse event resulting from use of the device was reported. 42 In 82% (287/350) of wounds, bacterial loads >10 4 CFU/g were observed, confirmed by microbiological analysis (Fig. 3).…”

Complications and risk factors of punch biopsy: A retrospective large‐scale study

“…Serena et al 5 reported on postoperative complications in a large multicenter clinical trial involving 412 skin biopsies for intractable skin ulcers using a 6-mm punch and found no significant difference in postoperative bleeding between patients receiving anticoagulation and those not receiving anticoagulation, similar to the results of our study.…”

Optimization of Laser-Based Method to Conduct Skin Ablation in Zebrafish and Development of Deep Learning-Based Method for Skin Wound-Size Measurement

“…In this consideration, rodents, like mice or rats, or even big mammalian animals, like pigs, were reported as good models to examine the skin wound-healing process and mechanism [6,70,71]. Moreover, there are some techniques that make use of more advanced tools, such as clinical dermatology lasers and biopsy punches, to investigate wound healing [11,14,23,26]. However, the clinical dermatology laser is relatively expensive and might be unaffordable to many laboratories.…”

“…However, this method is usually only performed in cells, as it is used to examine the cell migration of cells. Meanwhile, modern wound-healing experiments utilize more advanced tools, such as the biopsy punch and dermal laser [23][24][25][26][27]. The challenge for skin wound-healing experiments in fish is how to control the depth and size of the wound in a consistent manner.…”

“…The biopsy punch is a simple and effective diagnostic technique for wound management. However, professionals do not often use it for research because of various reasons, such as the invasive nature of the procedure or the fear of complications [23]. Another option is using a clinical dermal laser to conduct skin ablation [11,28].…”