Case Series

The Use of a Novel Desiccating Agent as an Adjuvant Therapy to Surgical Debridement in the Infected Diabetic Foot: A Case Series

by H. Erhan Güven1, Leandro Tapia Garcia2, Thomas Serena2*

1Department of General Surgery, University of Health Sciences, Ankara Etlik City Hospital,; Diabetic Foot and Chronic Wounds, Ankara, Turkey

2SerenaGroup® 125 Cambridge Park Dr. Cambridge, MA, USA

*Corresponding author: Thomas Serena, SerenaGroup® 125 Cambridge Park Dr. Cambridge, MA, USA

Received Date: 05 June 2024

Accepted Date: 10 June 2024

Published Date: 12 June 2024

Citation: Güven HE, Garcia LT, Serena T (2024) The Use of a Novel Desiccating Agent as an Adjuvant Therapy to Surgical Debridement in the Infected Diabetic Foot: A Case Series. J Surg 9: 11070 https://doi.org/10.29011/2575-9760.11070

Abstract

A common complication of diabetes, diabetic foot infections, can lead to devastating complications. Early antibiotic and surgical treatment are key to preserving the affected limb. Emergent surgical intervention is the mainstay of therapy; however, despite aggressive surgical debridement, some patients still go onto lower extremity amputation. Amputation in diabetics has a prognosis worse than the most common cancers. The need for advanced therapies in the treatment of the infected diabetic foot remains an unmet need. This case series reviewed the use of a novel Tissue Desiccating Agent (TDA), methanesulfonic acid, in combination with surgical debridement and antibiotics in the treatment of severe diabetic foot infections. Research suggests that the addition of a TDA facilitates debridement and disrupts both planktonic and biofilm-based bacteria promoting healing and decreasing the time to definitive reconstruction. A total of eleven patients were treated with the novel TDA. It was applied in the operating room at the time of the initial surgical intervention. Two cases are presented in detail. Overall, there appeared to be a more complete debridement and more rapid time to grafting with the addition of the desiccant. Further research into the role of TDAs in the treatment of the infected diabetic foot is warranted.

Keywords: Chemical debridement; Desiccating agent; Diabetic foot infection; Diabetic foot ulcer; Debridement; Necrotizing infection

Introduction

The World Health Organization defines Diabetic Foot Syndrome (DFS) as an ulceration of the foot associated with infection, neuropathy, and ischemia [1]. Threatening limb and life, DFS, is one of the most serious complications of diabetes [2]. Rapidly spreading infection in the diabetic foot can lead to extensive tissue destruction necessitating amputation. Prompt diagnosis and intervention reduces the risk of complications including amputation, sepsis, and death [3]. In addition to antibiotic therapy, surgery to remove necrotic material, including the fascial tissue, and drain pockets of purulence is the mainstay of treatment [4]. In most cases, the initial procedure for the severely infected diabetic foot does not remove all the nonviable and infected tissue. Repeat operative debridement is required [5]. The goal of treatment, once the acute infection subsides, focuses on reconstruction of the anatomy and wound closure. For many years, local flaps and split thickness skin grafting have played an integral role in the surgical approach [6]; however, these procedures require a granulating, uninfected wound bed without the presence of biofilm [7,8]. The addition of local agents that accelerate the debridement process may reduce the time to grafting or flap closure. In this case series, surgical debridement was combined with a novel topical dissecting agent (TDA, DebX Medical, Amsterdam, Netherlands) applied at the time of the initial surgical intervention in patients with severe diabetic foot infections. The goal was to supplement surgical debridement by removing residual infected tissue and disrupting biofilm and thereby decreasing the time to definitive closure.

Several studies suggest that acid-based desiccants are effective in the treatment of periodontal disease [9-11]. It is believed that the desiccants remove nonviable tissue and dehydrate and destroy biofilm [12]. Skin and soft tissue infections, like periodontal infections, have high bacterial bioburden, complex biofilm formation and high levels of inflammatory proteases; however, the desiccants used to treat periodontal disease are too astringent for open wounds. The novel tissue desiccant used in this study is a dehydrating compound, formulated by combining 99% methanesulfonic acid with proton acceptors and dimethyl sulfoxide. This combination is more suitable for open wounds [13].

Materials and Methods

This study was conducted by the primary author at a single medical center. It received ethics committee approval for publication by the local institutional review board (Ethical Board Approval, Date:14.02.2024 Number: AEŞH-BADEK-2024-124, Ankara Etlik Şehir Hastanesi). Prior to surgery, all patients signed an informed consent that included the publication of deidentified information and photography. Eleven(11) patients suffering from severe diabetic foot infections with necrotizing fasciitis of plantar and/or dorsal facia of the foot were treated through a combined surgical and chemical debridement approach using a tissue desiccant. Six of the 11 patients were recommended below-the-knee amputation at other hospitals. Preoperative evaluation, included history and physical examination, X-rays and comprehensive laboratories. Patient demographics and an overview of laboratory findings are shown in table 1. Broad spectrum antibiotics were started prior to taking the patient to the operating room because of the accompanying sepsis. The surgical intervention involved the excision of necrotic material, infected tissue, and drainage of abscesses. All the procedures were performed under a popliteal nerve block to minimize the risks associated with general anesthesia. Following the surgical debridement and thorough irrigation of the affected area, the topical dissecting agent was applied to further aid in debridement and biofilm control. Postoperatively, antibiotic therapy was continued to mitigate the risk of secondary infections and facilitate recovery. Repeat operative debridement was performed at the discretion of the surgeon. After resolution of the acute infection, the patients underwent split thickness skin grafting for wound closure.

Patient

Age

Sex

Comorbidities

Wound localization

1

62

M

Diabetes mellitus, acute myocardial infarction.

Right heel, and dorsal foot

2

61

M

Diabetes mellitus

Left medial dorsal foot

3

70

F

Diabetes mellitus

Dorsum right foot

4

58

F

Diabetes mellitus, hypertension, hyperlipidemia,

Left dorsal foot

5

42

M

Diabetes mellitus.

Interdigital space between 4th and 5th toes left foot

6

49

M

Diabetes mellitus, asthma.

First toe right foot

7

58

M

Diabetes mellitus, cataract, cerebrovascular aneurysm, congestive heart failure.

Fifth toe

8

72

M

Diabetes mellitus

Left foot first toe, and between 1 and 2

9

59

F

Diabetes mellitus, rheumatoid arthritis

Left foot

10

60

M

Diabetes mellitus, hyperlipidemia

Right foot

11

51

M

Diabetes mellitus

Right plantar foot

Table 1: Patient Demographics.

Case Studies

Case 1: A 62-year-old male with long standing diabetes mellitus was referred to the surgery department for treatment of a Wagner 4 diabetic foot ulcer on the right heel. The ulcer had been present for several weeks (Figure 1). His medical history included diabetes mellitus primarily treated with oral hypoglycemic agents. He had a history of coronary artery disease and suffered an acute myocardial infarction 20 years earlier and treated with a percutaneous coronary intervention (PCI). He had peripheral arterial disease for which he underwent stenting of an 80% occlusion of the right iliac artery and 100% occlusion of the right superficial femoral artery, in the month prior to admission. His blood work on admission is shown in Table 2. The patient's severe diabetic foot infection required immediate surgical intervention which included a prompt surgical drainage and debridement, complemented with chemical debridement with a topical dissecting agent spread over all the exposed surface of the wound (Figure 2). Three days post-surgery the patient underwent further surgical debridement and negative pressure wound therapy was initiated (Figure 3). Following a four-month healing period, during which the wound developed adequate granulation tissue, the patient underwent a successful grafting procedure (Figure 4). He had 100% graft take and complete wound closure (Figure 5).

Parameter

Patient

Normal Range

Unit

LRINEC

WBC

15.87

4.5-10

103/mm3

1

Hb

10

13-17

g/dL

2

Glu

196

80-120

mg/dL

1

CRP

138

0-5

mg/dL

0

Cr

1.28

0.7-1.2

mg/dL

0

Na

131

136-145

mmol/L

2

Total

6

HbA1c

9.4

4-6.1

%

Table 2: Blood work on admission.