ABSTRACT

Corresponding Author:
Dr. Yash Pandey,
Department of General Surgery,
Krishna Institute of Medical Sciences Deemed University,
Karad.
E-mail: dryash21@gmail.com

ABSTRACT

Diabetic foot ulcer will lead to a significant prolonged stress to the patients. Biological dressings like type 1 bovine collagen particles has advantage over conventional dressing in terms of early healing of wound. A total of 100 patients suffering from ulcer were taken randomly for this study after explaining the procedure and purpose of study. This was a comparative study between conventional dressing of ulcer and dressing with type 1 bovine collagen particles. There was significant difference in the result of collagen granules and conventional dressing. Collagen granules had better healing response rate.

AIMS AND OBJECTIVES.

To study the efficacy of topical agent type 1 bovine collagen granules in the management of diabetic foot ulcers.

METHODOLOGY

The patients who were admitted for diabetic foot ulcer at Dept. of Surgery, KIMS, Karad, tertiary care teaching centre during the study period were screened. 50 patients in the test group were treated with topical dressings of collagen granules. The control group of 50 patients was treated with conventional topical dressings and bedside debridement. Ulcer was noted using visual score.

RESULTS

The reduction of slough is as early as 3^rd week in test group than the control group. The number of patients with 75-100% wound filled with granulation tissue is as early as 3^rd week in test group than the control group where it took more than 4 weeks. The number of patients who underwent secondary suturing, skin grafting, and flap are significantly higher and also as early as 3^rd week in test group than the control group.

CONCLUSION

Collagen granules topical application enhanced wound healing of diabetic foot ulcer as compared to conventional treatment modalities.

KEYWORDS

Collagen Particles, Granulation Tissue, Wound.

INTRODUCTION

During the last decade, various new dressing materials developed like calcium alginate, hydrocolloid membranes, and fine mesh gauze. These have a disadvantage in that they become permeable to bacteria.^[1]

Biological dressings like collagen on the other hand create the most physiological interface between the wound surface and environment and are impermeable to bacteria. Collagen dressings have other advantages over conventional dressings

in terms of ease of application and being natural,

DISCUSSION

The number of patient studied was 100 and randomly divided into test group (50) and control group (50). Both the test and control groups were matched regarding their age, diabetic status, and nutritional status. The number of patients with no necrotic tissue is significantly higher in test group at 3^rd week followup (p<0.001), at 4^th week (p<0.001), at 5^th week (p<0.001), at 6^th week (p<0.001), and at the 7^th week (p<0.01) when compared to control group. There is minimal loss of viable tissue in the test group compared to control group because the number of bedside surgical debridement required is less and done superficially to remove dead tissue only.

The number of patients with 75-100% wound filled by granulation tissue is significantly higher in test group at 3^rd week followup (p<0.001), at 4^th week (p<0.001), at 5^th week (p<0.001), at 6^th week (p<0.001), and at 7^th week (p<0.005) when compared to control group.

The number of patients with no wound surface (nil) is significantly higher in test group at 3^rd week followup (p<0.05), at 4^th week (p<0.05), at 5^th week (p<0.05), at 6^th week (p< 0.001), and at the 7^th week (p<0.001) when compared to control group.

The duration of hospital stay was less in test group compared to control group.

Various factors have been implicated for an ulcer to develop in diabetic patients of which important is peripheral vascular disease, which causes decrease in sensation as a result of peripheral neuropathy.^[6] Secondary infection in a chronic ulcer is very common that will have a copious amount of discharge that smells foul. Antibiotic treatment for infection, wound dressing, pressure relief (special footwear, offloading, inserts, and casting), debridement, and desloughing are the traditional management approaches for diabetic ulcers.^[7] Embarrassing dressings, restricted mobility, and disability are the other issues that are often a great concern to the patients.^[8]

Collagens functions as structural proteins of extracellular matrix and are synthesised by the fibroblasts.^[9,10] In normal wound healing process, special enzymes called matrix metalloproteinases (MMPs) breaks down the malformed and damaged collagen present at the site of wound. So, when dressings containing collagen are used, the MMPS are kept busy breaking down that collagen and the healthy collagen that is innate of the body is thus protected helping in hastening the healing process.^[11] There are other modalities of dressing other than conventional Betadine dressing in ulcer management like sugar dressing, vacuum-assisted closure method. Direct instillation of sugar on the wound will result in low osmolar effect, promoting early granulation tissue formation, reduction in oedema. Hence, bacteriostatic effect is enhanced and thereby hastens the wound healing.^[12,13] Knutson and colleagues performed a study on wounds treated with granular sugar with povidone iodine to treat 605 patients with traumatic wounds and burns and observed reduction in healing time by 25%.^[14] But, there is still a lack in evidence explaining the cellular and molecular interactions between sugar and wound environment where in our study a molecular basis is explained. Vacuum-assisted wound closure is a recent and significant method of wound closure management. This method was first described by Fleishmann in 1993.^[15] This method works on application of controlled negative pressure on wound bed.

Gradual traction on living tissues can stimulate and promote regeneration of tissue structures. Morykwas et al studies showed decrease in the bacterial load in wounds treated with negative pressure therapy.^[16] There should be complete haemostasis before application of vacuum dressing and this has to be used in caution in patients with coagulopathies.

Collagen serves as the key extracellular component for repair and remodeling of skin tissue. As a biomaterial, collagen offers several advantages over traditional dressings, growth hormones, and biological coverings.^[17] The use of collagen as a drug delivery system is very comprehensive and diverse. Collagen can be extracted into an aqueous solution and molded into various forms of delivery systems. Due to its excellent biocompatibility and safety, the use of collagen in biomedical application has been rapidly growing and widely expanding to bioengineering areas.^[18] Collagen appears to be a good material for use as a biomedical implantable device and is used to form a matrix for regenerating tissue outside of the body, for example in regenerating skin for use in burns treatment, but increasingly it is also used in the development of other tissues offering the prospect of growing replacements for damaged organs. Collagen membranes are also chemotactic for regenerative cells and may enhance the migration and attachment of fibroblasts through its space-making ability.^[19]

Present study is a prospective study regarding collagen dressing versus conventional dressing. It was conducted between January 2015 to February 2016 in which 100 patients who presented with diabetic foot ulcer.

Various aetiologies were chosen by random sampling technique and were grouped into two groups consisting of 50 patients each to show the efficacy of collagen dressing.

The patient treated with collagen granules has faster reduction of slough/necrotic tissue and increased granulation tissue compared to study by OMKAR SINGH AND HARISH RAO.

Omkar Singh study reveals that regarding Collagen Dressing Versus Conventional Dressings in 120 patients with chronic wounds of varied aetiologies and with mean age 43.7 yrs. with two weeks of treatment, 60% of the ‘collagen group’ wounds, and only 42% of the ‘conventional group’ wounds were sterile (P=0.03).

Healthy granulation tissue appeared earlier over collagen-dressed wounds than over conventionally treated wounds (P=0.03). After eight weeks, 52 (87%) of ‘collagen group’ wounds and 48 (80%) of ‘conventional group’ wounds were >75% healed (P=0.21). Eight patients in the ‘collagen group’ and 12 in the ‘conventional group’ needed partial split-skin

grafting (P=0.04). Collagen-treated patients enjoyed early and more subjective mobility. No significant better results in terms of completeness of healing of burn and chronic wounds between collagen dressing and conventional dressing were found. Collagen dressing, however, may avoid the need of skin grafting and provides additional advantage of patients’ compliance and comfort.

In another study by Harish Rao regarding collagen dressings versus conventional dressings in wound healing of 100 patients with diabetic foot ulcer. In 75 patients collagen dressing was applied whereas conventional dressing in 25 patients. On enrollment, the median wound size was 33.5 cm2 in collagen dressing group and 48 cm2 in conventional dressing group. Healing time (4.02±0.59 vs. 7.6±1.38), duration of antibiotic therapy (15.12±4.55 vs 24.08±6.5), and mean followup period (2.40±0.61 vs. 2.96±1.2) were significantly less in collagen dressing group as compared to conventional dressing group (P<0.001). No adverse event was reported in both the groups. Collagen dressing is safe and effective in the treatment of foot ulcer and significantly reduces healing time, duration of antibiotic therapy, and followup time.

The present study made a comparison between the collagen dressing and conventional dressing. The efficacy and wound healing capacity of both the methods were gauged using suitable statistical test. The study revealed some interesting results: The study demonstrated that collagen granules dressing along with bedside surgical debridement had cumulative effect in reduction of slough, increase granulation tissue, and faster wound bed preparation.

The test group patients had increased growth of granulation tissue along with epithelisation, which is generally correlated with the development of a granulating wound bed. All this are done with visual score, so it cannot be determined whether there was increase in granulation tissue production resulting from the treatment or that more granulation was visible after debridement. But, patients in test group produced better result than control group.

The test group underwent skin grafting, secondary suturing, and flap as early as 3^rd week than control group because of faster wound bed preparation. The wound also healed faster because of increased epithelisation.

CONCLUSION

1. The study was done to give an insight to the depth of diabetic wound management as it has become a foremost problem in recent era.
2. The goal of this study was to enhance the wound/ulcers to be avoid of necrotic tissue and debris and to remove the senescent cells from the wound bed using type I Bovine Collagen Granules as the agents and preparing the wound for a healthy bed of granulation tissue to promote a rapid healing.
3. This is achieved in our study by using type 1 Bovine Collagen Granules, which is proved to be highly effective in reduction of slough, promoting granulation tissue formation, and reepithelialisation.
4. Type 1 Bovine Collagen Granule prove to be significantly effective in wound bed preparation in comparison with conventional treatment with local antiseptics.