Outcomes of Vacuum Assisted Closure versus Conventional Dressings in patients with Diabetic Foot Ulcers

doi:10.21203/rs.3.rs-4830001/v1

Download PDF

Research Article

Outcomes of Vacuum Assisted Closure versus Conventional Dressings in patients with Diabetic Foot Ulcers

https://doi.org/10.21203/rs.3.rs-4830001/v1

This work is licensed under a CC BY 4.0 License

Version 1

posted

You are reading this latest preprint version

Introduction:

To compare the effectiveness of Vacuum Assisted Closure (VAC) dressing over Conventional Dressing in case of Diabetic Foot Ulcers.

In view of this, the present study was planned to weigh between Vacuum Assisted Closure (VAC) and the conventional dressing methods in case of Diabetic Foot Ulcer in factors like rate of granulation tissue formation, Bacterial clearance in the end of the therapy and duration of wound healing.

Patients and Methods:

This was a randomized comparative study conducted in the department of General Surgery, Indira Gandhi Institute of Medical Sciences, Patna from January 21 to December 22.50 patients with lower limb diabetic ulcers were included who were randomized into two groups-Conventional Dressing was done(n = 31); Vacuum Assisted Closure (VAC) dressing was done(n = 19). Patients were compared for outcomes after dressing. Statistical Analysis was done by SPSS software and P value < 0.05 were considered statistically significant.

Result:

Compared to Conventional Dressing,Vacuum Assisted Closure (VAC) Dressing group had comparable age,gender and associated comorbidities (p value > 0.05), took less but comparable duration for granulation tissue to appear (6.94SD2.61 vs. 9.03SD2.30, p value-0.29) took significantly lesser duration for wound culture to be negative (11.36SD4.47 vs. 14.83SD3.89, p value-0.037), took significantly lesser duration for wound healing (36.84SD9.34 vs. 43.16SD9.22, p value-0.033).

Conclusion:

Vacuum Assisted Closure (VAC) dressing was advantageous over Conventional Dressing for Dressing of lower limb diabetic ulcers in terms of time taken for formation of granulation tissue, time taken for wound culture to be negative and on long term follow ups, also in duration of healing of wounds.Vacuum Assisted Closure (VAC) dressing for chronic wounds or ulcers seemed to be a promising option to conventional dressing and the short-term results were good.

Diabetic Ulcer

Vacuum Dressing

Normal Saline Dressing

Lower limb

India, is one of the first nations most affected with diabetes, foot ulceration is the most common complication, affecting approximately 15% of diabetic patients [1]. Patients with DM have up to a 25–35% lifetime risk of developing a foot ulcer [2], which precedes amputation in up to 85% of cases [3]. The management of the Diabetic foot ulcers is largely determined by its severity (grade), vascularity of the limb, and the presence of infection [4–6]. The optimal topical therapy for Diabetic Foot Ulcers is not well defined. Saline moistened gauze has been the standard method; however, it has been difficult to continuously maintain a moist wound environment. Subsequently, various hydrocolloid wound gels, growth factors, enzymatic debridement compounds, hyperbaric oxygen therapy, cultured skin substitutes, and other wound therapies have been advocated.[7]. Negative-pressure wound therapy (NPWT) is a relatively newer technique in managing complex wounds. It was first described by Charikar [8] as an experimental technique for treating subcutaneous fistulas. However, it was the clinical work by Argenta and Morykwas a decade later that allowed Negative-pressure wound therapy (NPWT) to gain recognition as a useful clinical tool for managing complex and difficult wounds [9–11]. Today,Negative-pressure wound therapy (NPWT) is well established for treating trauma wounds, general surgical wounds, and diabetic foot wounds. Supporting evidence for Negative-pressure wound therapy (NPWT) in the treatment of diabetic foot wounds includes numerous prospective and multi-centered randomized controlled trials [12]. Vacuum Assisted closure (VAC) is a non-invasive, active wound management system, which uses negative pressure in order to enhance the healing process and increase local blood flow and reduce oedema and bacterial colonization and promote closure of the wound by promoting the rapid formation of granulation tissue [13]. Recent studies have shown that application of a sub atmospheric pressure in a controlled manner to the wound site has an important role in assisting wound healing [14]. Complex effects at the wound-dressing interface following application of a controlled vacuum force have been documented. These include changes on a microscopic, molecular level and on a macroscopic, tissue level: interstitial fluid flow and exudates management, oedema reduction, effects on wound perfusion, protease profiles, growth factor and cytokine expression and cellular activity, all leading to enhanced granulation tissue formation and improved wound healing parameters [15–17]. In view of this, the present study was planned to weigh between Vacuum Assisted Closure (VAC) and the conventional dressing methods in case of Diabetic Foot Ulcer in factors like rate of granulation tissue formation, Bacterial clearance in the end of the therapy and duration of wound healing.

The study was conducted in the Department of General Surgery, IGIMS Patna, Bihar, India, after obtaining clearance from the Institutional Ethics Committee (IEC). Informed written consent was obtained from each patient.The study was a Prospective single centre, randomized comparative study comparing two methods for Diabetic Foot ulcer dressing. The study was carried out from December 2020 to December 2022.

INCLUSION CRITERIA-

• Above 18 years of age • An informed written consent will be obtained from the patient. • Patients with lower limb ulcers with ulcer size between 5–15 cm.• Be able and willing to comply with the study procedure.

EXCLUSION CRITERIA-

• Patients aged > 70 years. • Pregnant or nursing mothers.• People on medications, such as corticosteroids, immuno-suppressive agents or chemotherapy. • Ulcers with underlying osteomyelitis of the bone. •Patients not willing to participate in the study.

Sample Size: A sample size of 50 patients was included in the study. Eligible Patients were informed about the study by the attending doctor at the outpatient department of General Surgery.

The patient was seen in Surgery OutPatient Department (OPD).History was taken and clinical examination was done. The patients who were fulfilling the inclusion criteria were given the consent form to sign and after taking consent for their participation in the study, they were included in the participating pool. Total participating pool was divided randomly into 2 groups ·

Wounds of all the patients included in the study underwent surgical debridement initially and during subsequent dressing change to remove necrotic tissue and slough. Patients in both groups were administered with insulin therapy according to their blood sugar levels and injectable antibiotics were started empirically initially and then according to the culture and sensitivity report. Patients admitted with other comorbidities like Hypertension, Tuberculosis, Hypothyroidism were treated as per the consultation provided from the respective departments of the institute and if any intervention was required for the same, Patient was free to undergo the intervention.

GROUP A (Vacuum Assisted Closure)

After debridement in the emergency operation theatre, a foam-based dressing was applied over the wounds of the study group patients under all aseptic conditions. The dressing was covered with an adhesive drape to create an airtight seal. An evacuation tube embedded in the foam was connected to a vacuum and sub atmospheric (negative) pressure was applied within a range of 80–125 mm Hg on a continuous basis for 96 hours. The tube drained the secretion into a collection canister. In this way, a previously open wound was converted into a controlled, closed and moist wound. Dressings were regularly changed every 4 days during the admission period.

GROUP B (Conventional dressing)

Patients were treated with conventional dressings. Alternate day dressings were done during admission period.

Wound tracing and photos were taken every 4 days during the first two weeks after admission to look for granulation tissue and compare the wound size. Swab for culture report was taken at admission and every fourth day during the first two weeks after admission.On the 8th day, culture sensitivity, wound size, granulation tissue were noted. · Ulcers were treated until the wound was closed spontaneously, surgically or until completion of the 8-week period, whichever was earlier. · Patients who were discharged from the hospital after wound closure were followed monthly in the surgical OPD. · Treatment success was defined as wound closure within a period of 8 weeks and failure, as inability of wound closure within 8 weeks.

Statistical analysis

Categorical variables were presented in number and percentage and continuous variables were presented as mean ± SD and median. Normality of Data was tested by Kolmogorov-Smirnov test. If the normality is rejected then a non parametric test was used. Statistical tests will be applied as follows. Quantitative variables were compared using Unpaired T Test/Mann Whitney Test (when the data sets were not normally distributed) between the two groups. Qualitative Variables were compared using Chi Square test/Fisher’s exact test. A p value of < 0.05 was considered statistically significant.The data was entered in MS EXCEL spreadsheet and analysis was done using Statistical Package for Social Sciences (SPSS) version 22.0.

Computerized Randomization Technique-To randomly select among two groups ,the random number generating function RANDBETWEEN () was used with lower limit as 1 and upper limit as 2. If 1 is generated, the conventional dressing group was allocated and if 2 is generated, Vacuum Assisted Closure (VAC) dressing group was allocated.

Application of Vacuum Assisted Closure (VAC) Dressing on Day 1

The demographic details of the patients in our study are mentioned in Tables 1–4.The overall mean age of Conventional Dressing Group was 51.7097 as compared to 52.9474 years in Vacuum Assisted Closure (VAC) group.38 patients were males and 18 were females.13 Patients have associated hypertension with type 2 diabetes whereas only 3 patients have associated hypothyroidism.

Table 1

Association between Age in group: TYPE OF DRESSING USED
TYPE OF DRESSING USED
Age in group	Conventional dressing	Vacuum-Assisted Closure (VAC)	Total
≤ 40	2	2	4
41–50	14	6	20
51–60	10	6	16
61–70	5	5	10
TOTAL	31	19	50

Chi-square value: 1.4007; p-value: 0.7054

Table 2

Association between Gender: TYPE OF DRESSING USED
TYPE OF DRESSING USED
Gender	Conventional dressing	Vacuum-assisted Closure (VAC)	Total
Female	9	3	12
Male	22	16	38
Total	31	19	50

Chi-square value: 1.1326; p-value: 0.2872

Odds Ratio 2.1818 (0.5084, 9.3643)

Table 3

Association between Co morbidity: TYPE OF DRESSING USED
TYPE OF DRESSING USED
Comorbidity	Conventional dressing	Vacuum-Assisted Closure (VAC)	Total
T2DM	22	10	32
T2DM, HTN	7	6	13
T2DM, TB	0	2	2
T2DM,THYROID	2	1	3
TOTAL	31	19	50

Chi-square value: 4.2766; p-value: 0.2331

(T2DM-Type 2 Diabetes Mellitus,HTN-Hypertension,TB-Tuberculosis)

Table 4

Distribution of mean Age: TYPE OF DRESSING USED
		Number	Mean	SD	Minimum	Maximum	Median	p-value
Age	Conventional dressing	31	51.7097	8.4150	39.0000	70.0000	50.0000	0.6205
Age	Vacuum-assisted closure	19	52.9474	8.7017	38.0000	66.0000	52.0000	0.6205

In this study it was found that 21 patients out of total 31 patients in the Conventional Dressing Group developed granulation tissue at the end of 8th day whereas 17 out of 19 patients in the Vacuum Assisted Closure (VAC) dressing Group had granulation tissue at the end of the 8th day.

Table 5: Distribution of mean Time Taken For Granulation Tissue To Appear (Days) : TYPE OF DRESSING USED

		Number	Mean	SD	Minimum	Maximum	Median	p-value
Time Taken For Granulation Tissue To Appear (Days)	Conventional dressing	31	9.0322	2.3019	4.0000	12.0000	8.0000	0.292
Time Taken For Granulation Tissue To Appear (Days)	Vacuum-assisted closure	19	6.9473	2.6135	4.0000	12.0000	8.0000	0.292

Mean ± SD of time taken for granulation tissue to appear (Days) in Conventional Dressing is 9.03SD2.30 which is comparable to Vacuum Assisted Closure (6.94SD2.61)(p value-0.292).It is shown in Table 5.

In the study, it was found at the end of 8th day, only 4 patients out of total 31 patients in the Conventional Dressing Group had sterile wound culture compared to 10 patients out of 19 patients in Vacuum Assisted Closure (VAC) Dressing Group.

Table 6: Distribution of mean Time Taken For Wound Culture To Be Negative (Days) : TYPE OF DRESSING USED

		Number	Mean	SD	Minimum	Maximum	Median	p-value
Time Taken For Wound Culture To Be Negative (Days)	Conventional dressing	31	14.8387	3.8909	4.0000	20.0000	14.0000	0.037
Time Taken For Wound Culture To Be Negative (Days)	Vacuum-assisted closure	19	11.3684	4.4747	4.0000	20.0000	14.0000	0.037

Mean ± SD of time taken for wound culture to be negative (Days) in Conventional Dressing was 14.83SD3.89 which was significantly more to Vacuum Assisted Closure (11.37SD4.47)(p value-0.037).It is shown in Table 6.

Table 7

Distribution of mean Duration Of Healing (Days) : TYPE OF DRESSING USED
		Number	Mean	SD	Minimum	Maximum	Median	p-value
Duration Of Healing (Days)	Conventional dressing	31	43.1612	9.2271	28.0000	62.0000	42.0000	0.033
Duration Of Healing (Days)	Vacuum-assisted closure	19	36.8421	9.3408	18.0000	58.0000	40.0000	0.033

Mean ± SD of Duration of Healing in Conventional Dressing was 43.17SD9.22which was significantly higher to Vacuum Assisted Closure Dressing (36.84SD9.34). (p value-0.033). It is shown in Table 7.

The present study was a randomized comparative study on 50 known Diabetic patients with lower limb ulcer [31 patients who underwent Conventional Dressing and 19 patients underwent Vacuum Assisted Closure (VAC) dressing] where we aimed to compare the effectiveness of Conventional Dressing with Vacuum assisted Closure (VAC) in case of lower limb diabetic ulcer. We found that Vacuum assisted Closure (VAC) dressing resulted in less duration for granulation tissue to appear, for wound culture to be negative and less duration for healing. The study demographics of the population showed that the cases were comparable to controls in terms of age, gender and associated comorbidities. In a randomized comparative trial like ours, the similarity of the characteristics of the patient ensures that any difference in outcome is purely due to intervention and not due to chance bias. In our study, most of the patients usually presented with chronic non healing lower limb ulcers due to the chronicity of the disease (T2DM) associated with some other comorbidities. Our study consisted of 50 patients which were randomly divided into two groups, Group A of conventional Dressing of 31 patients while Group B of Vacuum assisted Closure (VAC) dressing of 19 patients. Among other studies, Lone et al consists of 56 patients randomly divided in two even groups [7]. Management of foot ulcer is largely determined by grade of ulcer, vascularity, and presence of infection. Current therapeutic options of Diabetic Foot Ulcer management include repeated debridement, pressure offloading, and treatment of ischemia, metabolic stabilization and preventive strategies incorporated at primary healthcare level.Several studies have followed and identified faster healing times with Negative-pressure wound therapy (NPWT) when compared to moisturized saline gauze.Vacuum assisted Closure (VAC) is generally well tolerated and, with few contraindications or complications, is fast becoming a mainstay of current wound care. Hence, we planned to use Negative-pressure wound therapy (NPWT) for the treatment and fast healing of Diabetic Foot ulcers. Duration for Granulation Tissue to appear In the present study, compared to conventional dressing,Vacuum assisted Closure (VAC) group took less but comparable duration for granulation tissue to appear (9.032SD2.30 vs. 6.94SD2.61, p value-0.29). Among previous studies, Lone et al found that the Vacuum assisted Closure (VAC) group took significantly less time for granulation tissue to appear when compared to conventional dressing(66.7% of Vacuum assisted Closure (VAC) group patients developed granulation tissue by end of 4 weeks vs. 28% in case of conventional dressing.)(p value-0.049) [7].In D'Souza et AL, it was found that at the end of first dressing on day 4,about 70% of Vacuum assisted Closure (VAC) group wounds had red granulation tissue as compared to 47% in case of Conventional dressing which was significantly higher.(p value-0.038) [1]. Time Taken for wound culture to be negative in the present study, compared to conventional Dressing,Vacuum assisted Closure (VAC) group took significantly less duration for wound culture to be negative (11.37SD4.47 vs 14.83SD3.89, p value-0.037). Among previous studies, Lone et al showed that the cultures were reported sterile in week 1 itself after application of Vacuum assisted Closure (VAC) as compared to week 2 in normal dressing [7]. However, in D’Souza et al, in the Vacuum assisted Closure (VAC) group 72.73% ulcers had no bacteria at the end of therapy whereas in the Conventional Dressing group, 79.17% were rendered sterile at the end of therapy (Duration of Therapy-2 weeks) [1]. Duration for Wound Healing In the present study, compared to conventional Dressing, Vacuum assisted Closure (VAC) group took significantly less duration for wound healing (36.84SD9.34 vs 43.17SD9.22, p value-0.033). Among previous studies, in Lone et al, the majority of wounds in Vacuum assisted Closure (VAC) Group (81.8%) got closed in 5 weeks as compared to only 60% in Conventional Dressing Group in 8 weeks [7]. Five cases in the Conventional Dressing group failed to heal within the duration of 8 weeks (56 Days) resulting in Treatment Failure as compared to only one case in Vacuum assisted Closure (VAC) Dressing group. Overall,Vacuum assisted Closure (VAC) Dressing seemed to be a novel method for dressing of lower limb diabetic ulcers with better outcomes than Conventional Dressing.

In the study it was found that the Vacuum assisted Closure (VAC) dressing was advantageous over Conventional Dressing for dressing of lower limb diabetic ulcers in terms of time taken for formation of granulation tissue, time taken for wound culture to be negative and on long term follow ups,also in duration of healing of wounds.Vacuum assisted Closure (VAC) dressing for chronic wounds or ulcers seemed to be a promising option to Conventional Dressing and the short term results were good.However,Vacuum assisted Closure (VAC) dressing can cause a monetary burden over patient in comparison with conventional dressings.Thus,based on our experience in this study, Vacuum Assisted Closure(VAC) dressing can be suggested as a feasible technique for the dressing of Chronic Ulcers especially Diabetic Ulcer.

Authors’ Contributions

• Study conception and design-Piyush Ranjan

• Acquisition of data-Piyush Ranjan,Rishika and Saptarshi Mondal

• Analysis and interpretation of data-Piyush Ranjan

• Drafting of manuscript-Piyush Ranjan

• Critical revision of manuscript-Rishika,Saptarshi Mondal

Dsouza, C., Diaz, E., & Rao, S. (2017: A randomized controlled trial comparing low-cost vacuum assisted dressings and conventional dressing methods in the management of diabetic foot ulcers. International Surgery Journal. 4:3858-3865.
Nalini S, David G, Armstrong DG, Lipsky BA: Preventing foot ulcers in patients with diabetes . JAMA. 2005, 293:217-28.
Reiber GE, Vileikyte L, Boyko EJ, del AM, Smith DG, LaveryLA, et al. Causal pathways for incident lower extremity ulcers in patients with diabetes from two settings. Diabetes Care. 1999, 22:157-62.
Frykberg RG: Diabetic foot ulcerations. In: RG Frykberg (ed.), The high-risk foot in diabetes mellitus. New York: Churchill Livingstone; 1991. pp.:151-95.
Frykberg RG: Diabetic foot ulcers: current concepts. J Foot Ankle Surg. 1998, 37:440-6.
Frykberg RG, Armstrong DG: Giurini J, Edwards A, KravetteM, Kravitz S, et al. Diabetic foot disorders: a clinical practice guideline. American College of Foot and Ankle Surgeons. JFoot Ankle Surg. 2000, 39:1-60.
Ali M. Lone, Mohd I. Zaroo, Bashir A. Laway, Nazir A. Pala, Sheikh A. Bashir & Altaf Rasool (2014: Vacuum assisted closure versus conventional dressings in the management of diabetic foot ulcers: a prospective case-control study. Diabetic Foot & Ankle. 5:1. 10.3402/dfa.v5.23345
Chariker ME, Jeter KF, Tintle TE, Bottsford JE: Effective management of incisional and cutaneous fistulae with closed suction wound drainage. Contemp Surg. 1989, 34:59-63.
Argenta LC, Morykwas MJ: Vacuum-assisted closure: a new method for wound control and treatment: clinical. experience. Ann Plast Surg. 1997, 38:563-76.
Morykwas MJ, Argenta LC: Non Surgical modalities to enhance healing and care of soft tissue wounds . J South Orthop Assoc 1997. 6:279-88.
Morykwas MJ, Argenta LC, Shelton-Brown EI: McGuirt Vacuum-assisted closure: a new method for wound control and treatment: animal studies and basic foundation. Ann Plast Surg1997. 38:553-62.
Muhammed Y. Hasan, Rachel Teo & Aziz Nather (2015: Negative-pressure wound therapy for management of diabetic foot wounds: a review of the mechanism of action, clinical applications, and recent developments. Diabetic Foot & Ankle. 6:1. 10.3402/dfa. v6.27618
A Randomized Comparative Study of Vacuum Assisted Dressing V/S Conventional Dressing in Management of Chronic Wounds In Diabetic Patients. European Journal of Molecular & Clinical Medicine. 9:834-842.
Al-Mallah, A., Al-Sayed, A., & Bayoumi, A. (2018: Negative pressure wound therapy versus conventional dressing in treatment of diabetic foot wound. The. Egyptian Journal of Hospital Medicine. 72:4054-4059. 10.21608/ejhm.2018.9115
Riaz, M. U., Khan, M. U. R., & Akbar, A. (2010: Comparison of vacuum assisted closure versus normal saline dressing in healing diabetic wounds. Pakistan Journal of Medical & Health Sciences. 4:308-313.
Ali, Anjum, Khurshid RETRACTED ARTICLE: Evaluation of low-cost custom-made VAC therapy compared with conventional wound dressings in the treatment of non-healing lower limb ulcers in lower socioeconomic group patients of Kashmir valley. J Orthop Surg Res 10. 183:
Janugade, Chhabra, Das: Outcomes of VAC versus conventional dressings in patients with lower limb ulcer. International Surgery Journal. 5:1792-1796.

Charts are available in the Supplementary Files section.

No competing interests reported.

Charts.docx

Download PDF

Version 1

posted

You are reading this latest preprint version

Outcomes of Vacuum Assisted Closure versus Conventional Dressings in patients with Diabetic Foot Ulcers

Status:

Version 1

Abstract

Figures

Introduction

Patients And Methods

INCLUSION CRITERIA-

EXCLUSION CRITERIA-

Methodology

GROUP A (Vacuum Assisted Closure)

GROUP B (Conventional dressing)

Statistical analysis

Results

Discussion

Conclusion

Declarations

References

Charts

Additional Declarations

Supplementary Files

Status:

Version 1