Abstract
Background
Low cost Negative Pressure Wound Therapy (NPWT) dressings have been considered as an alternative to traditional daily dressings. There is scanty literature evaluating the change in the percentage area of wound covered by granulation tissue following application of low-cost NPWT. The change in the bacteriological flora following application of low-cost NPWT devices has also not been evaluated.
Methods
Patients above the age of 18 years with acute musculoskeletal injuries of <3 weeks duration which underwent a surgical debridement and required subsequent wound coverage were included in the study. Area of the wound and the area covered by the granulation tissue as well as the bacteriological count were measured before and after application of NPWT. A low cost NPWT using wall mounted vacuum device was put on the patient giving a constant negative pressure of 125 mm of Hg for 2 days. The findings before and after application of NPWT were compared and analyzed using Wilcoxin Signed-rank test.
Results
21 patients with mean age of 35.52±15.075 were included. The pre-NPWT granulation tissue area ranged from 122 mm2 to 8483 mm2 with a mean of 1648.38 mm2 (SD = 1933.866). The post-NPWT granulation tissue area ranged from 234 mm2 to 7847 mm2 with a mean of 2364.48 mm2 (SD = 1857.716). The mean increase in granulation tissue was 716.1 mm2.The pre-NPWT wound area ranged from 422 mm2 to 10847 mm2 with a mean of 4009.62 mm2 (SD = 3026.209). The post-NPWT wound area ranged from 326 mm2 to 9143 mm2 with a mean of 3410.33 mm2 (SD = 2636.206). The mean reduction in wound size was 599.29 mm2.The pre-NPWT bacteriological count ranged from 3000/ml to 130000000/ml with a mean of 12616761.90/ml (SD = 29664589.37). The post-NPWT bacteriological count ranged from 1000/ml to 380000000/ml with a mean of 26401523.81/ml. The mean increase in bacteriological count was 13784761.91/ml.
Conclusion
There was a statistically significant decrease in wound size (p = 0.001) and statistically significant increase in percentage area of granulation tissue coverage (p = 0.000) following low cost NPWT application. However there was no statistically significant increase in bacteriological clearance in these patients.
Keywords: Negative pressure dressing, Open wounds, Negative pressure wound therapy, Musculoskeletal injuries, Vacuum assisted closure, Low cost
1. Introduction
Negative pressure wound therapy (NPWT) has been shown to improve the healing of wounds due to varied mechanisms such as increased blood flow to the damaged tissue, decreased interstitial edema, increased wound contraction, increased granulation of wound beds, and increased bacteriological clearance.1,2,3,4,5
Topical NPWT has been shown to be effective in improving granulation tissue formation and maturation.5 A larger increase in the granulation tissue may help to optimize wound conditions prior to wound closure or coverage, especially in musculoskeletal injuries.6 The effect of NPWT on the reduction of bacterial load in acute traumatic musculoskeletal wounds is also an important part of effective treatment.7 Various studies have shown NPWT to be inherently bacteriostatic while other studies have reported selective suppression of non-fermentative gram-negative bacilli (NFGNB), including Pseudomonas species, following NPWT. The assumption that NPWT suppresses proliferating bacteria is debatable.8
Various low-cost NPWT devices have been tried by various authors for limb wounds/ulcers.9, 10, 11, 12, 13, 14, 15 In settings with limited medical resources, simplified NPWT dressings have been considered as an effective alternative to traditional daily dressings.16,17 To the best of our knowledge there is no literature evaluating the change in the percentage area of wound covered by granulation tissue following application of low-cost,wall mounted NPWT device. The change in the bacteriological flora following application of low-cost NPWT devices has also not been evaluated. The current study was conducted to fill these lacunae.
2. Materials and methods
This prospective interventional study was conducted at a tertiary care center following approval by Institutional Ethics Committee. It included 21 patients of either sex above the age of 18 years with acute musculoskeletal injuries of less than 3 weeks’ duration having undergone surgical debridement and requiring subsequent wound coverage. Patients who had immunosuppression, were on anticoagulants, had wounds with exposed bone, nerves, vessels and chronic osteomyelitis were excluded from the study.16
After obtaining a written informed consent from the patients the wound was surgically debrided in the operation theatre. Subsequently in the ward a low-cost wall mounted NPWT was applied on the wound (Fig. 1).
Fig. 1.
NPWT applied to a patient with a wound on the right thigh.
Prior to the application of low cost NPWT two swabs were taken from the wound bed (for microbiological sampling prior to NPWT application), by twirling the end of the swab stick on a 1 cm2 area in the centre of the wound for 5 s with enough pressure to cause minimal bleeding.18,19 The same procedure was repeated on the wound following the removal of NPWT.
The first swab was used for direct routine bacteriological culture (MacConkey and blood agar plating followed by incubation at 37 °C for 18–24 h after which the plate was assessed as per the standard protocol) and gram staining. The second swab was sent for bacteriological count. Using aseptic technique, the swab was transferred to a pre-measured sterile saline tube and thereafter 1 ml of the preparation was used to make dilutions of 10−2, 10−4, 10−6. These dilutions were aseptically transferred to petri-plates using nutrient agar as the media. The number of bacteria (Colony Forming Unit/ml) of the sample was determined using the formula:
Microbiological identification of colonies was done using the standard protocol for pus/wound processing in microbiological laboratory and the findings were recorded for statistical analysis.20
Simultaneously the area of the wound and the granulation tissue coverage were marked on a standard A4 size transparent sheet (OHP sheet) with pre-printed grids of 1 mm2
(which has been kept in a formalin chamber for a minimum of 24 h) after placing it on the wound surface (Fig. 2). The tracings of the wound and the visible granulation tissue were marked on the transparent sheet with a sterile marking pen. The surface area of the wound and the surface area of the visible granulation tissue traced on the transparent paper were calculated in mm2 (Fig. 2).
Fig. 2.
Standard transparent sheets with pre-printed grids of 1 mm square.
The percentage of area covered by granulation tissue in relation to the total surface area of the wound was calculated as per the formula:
The same procedure was repeated on the wound following the removal of NPWT dressing.
Commercially available polyurethane foam of 1.25 inches thickness was autoclaved for the application of low cost NPWT dressing. The sterile foam was cut according to the wound contours and then it was placed gently onto the wound cavity to provide an even distribution of negative pressure.10,12,13 A sterile adhesive drape (IOBAN®3M) was put to seal the wound and the polyurethane foam and covered up to 4–5 cm of normal surrounding skin to ensure effective wound sealing.
A 1-cm cut was made in the adhesive drape dressing and superficial part of the polyurethane foam and a regular suction tube was put into the foam not touching the wound.10 The edges of the cut were sealed by impervious stickers in a mesentery like covering. The other end of the suction tube was connected to a wall mounted vacuum suction pump with a gauze meter for pressure control which are rouinely available in regular wards. The amount of continuous negative pressure applied was 125 mm of Hg.3,5,16,21,22 The NPWT dressing (Fig. 3) was changed after 2 days of application (see Fig. 4).
Fig. 3.
Application of sterile foam onto the wound covered by IOBAN ®3M drape.
Fig. 4.
A) Shows wound on the shoulder prior to the application of NPWT. 4 B) shows tracing of the wound on the transparent sheet of grid, showing islands of granulation tissue (area with streaks) prior to application of NPWT. 4C) shows the wound following the application of NPWT for 48 h 4D) shows tracing of the wound on the transparent sheet with grid showing the increase in the area of granulation tissue (area with streaks).
The size of the wound (in mm2) and the area of granulation tissue (in mm2) were measured prior to and after removal of low cost NPWT dressing as per the previously described method and recorded in predesigned performa for statistical analysis.
The data was recorded in MS Excel spreadsheet program and analyzed using SPSS software version 20.0. Descriptive statistics were elaborated in the form of means/standard deviations and medians/IQRs for continuous variables, and frequencies and percentages for categorical variables. Due to the high variability in wound size, granulation tissue and bacteriological count, the data was considered to be non-uniform. Hence, Wilcoxon Signed-rank test, which is a non-parametric test was applied (p value of less than 0.05 was considered to be significant).
3. Results
Twenty one patients (17 male, 4 female) with mean age of 35.5 years were included in the study. There was statistically significant reduction in wound size (p = 0.000) following application of low cost wall mounted NPWT device (Table 1).
Table 1.
Reduction in wound size following application of low cost wall mounted NPWT device.
| SERIAL NUMBER | AGE SEX | WOUND AREA PRE-NPWT (IN MM2 | WOUND AREA POST-NPWT (IN MM2) | REDUCTION IN WOUND AREA (IN MM2) | PERCENTAGE REDUCTION IN WOUND SIZE (IN %) |
|---|---|---|---|---|---|
| 1 | 78/M | 6200 | 5760 | 440 | 7.09 |
| 2 | 28/M | 6118 | 5354 | 764 | 12.48 |
| 3 | 42/M | 8416 | 8194 | 222 | 2.63 |
| 4 | 18/M | 422 | 326 | 96 | 22.75 |
| 5 | 22/F | 6032 | 4250 | 1782 | 29.54 |
| 6 | 50/M | 2602 | 2132 | 470 | 18.06 |
| 7 | 24/M | 4118 | 2984 | 1134 | 27.54 |
| 8 | 62/M | 4928 | 4249 | 679 | 13.78 |
| 9 | 22/F | 1392 | 1155 | 237 | 17.02 |
| 10 | 26/M | 4295 | 3854 | 441 | 10.27 |
| 11 | 18/M | 1906 | 1452 | 454 | 23.82 |
| 12 | 45/M | 664 | 574 | 90 | 13.55 |
| 13 | 30/M | 4011 | 3048 | 963 | 24.01 |
| 14 | 35/M | 825 | 645 | 180 | 21.82 |
| 15 | 40/M | 1503 | 1201 | 302 | 20.09 |
| 16 | 36/M | 9998 | 8165 | 1833 | 18.33 |
| 17 | 32/F | 1595 | 1408 | 187 | 11.72 |
| 18 | 34/M | 1639 | 1412 | 227 | 13.85 |
| 19 | 30/F | 3971 | 3724 | 247 | 6.22 |
| 20 | 24/M | 2720 | 2587 | 133 | 4.89 |
| 21 | 50/M | 10847 | 9143 | 1704 | 15.71 |
The pre-NPWT wound area ranged from 422 mm2 to 10847 mm2 with a mean of 4009.62 mm2 (SD = 3026.209). The post-NPWT wound area ranged from 326 mm2 to 9143 mm2 with a mean of 3410.33 mm2 (SD = 2636.206). Thus, the mean reduction in wound side was 599.29 mm2after application of low cost NPWT.
The increase in the granulation tissue coverage following application of low-cost wall mounted NPWT device was found to be statistically significant (p = 0–001).
The pre-NPWT granulation tissue area ranged from 122 mm2 to 8483 mm2 with a mean of 1648.38 mm2 (SD = 1933.866). The post-NPWT granulation tissue area ranged from 234 mm2 to 7847 mm2 with a mean of 2364.48 mm2 (SD = 1857.716). Thus, the mean increase in granulation tissue area was 716.1 mm2 following application of low cost NPWT (Table 2).
Table 2.
Percentage increase in granulation tissue area following application of low cost wall mounted NPWT device.
| SERIAL NUMBER | AGE/SEX | AREA OF GRANULATION TISSUE COVERAGE PRE-NPWT (IN MM2) | AREA OF GRANULATION TISSUE COVERAGE POST-NPWT (IN MM2) | PERCENT AGE GRANULATION TISSUE COVERAGE PRE-NPWT | PERCENTAGE GRANULATION TISSUE COVERAGE POST-NPWT | PERCENTAGE CHANGE IN GRANULATION TISSUE COVERAGE |
|---|---|---|---|---|---|---|
| 1 | 78/M | 3718 | 4736 | 59.96% | 82.20% | 22.24% |
| 2 | 28/M | 3748 | 4238 | 61.26% | 79.15% | 17.89% |
| 3 | 42/M | 2222 | 3494 | 26.40% | 42.64% | 16.24% |
| 4 | 18/M | 122 | 234 | 28.90% | 71.70% | 42.80% |
| 5 | 22/F | 2922 | 3313 | 48.44% | 77.95% | 29.51% |
| 6 | 50/M | 267 | 1165 | 10.06% | 54.64% | 44.58% |
| 7 | 24/M | 1612 | 2623 | 39.14% | 87.90% | 48.76% |
| 8 | 62/M | 2217 | 3693 | 44.98% | 86.91% | 41.93% |
| 9 | 22/F | 974 | 1056 | 69.97% | 91.42% | 21.45% |
| 10 | 26/M | 1730 | 3141 | 40.27% | 81.49% | 41.22% |
| 11 | 18/M | 821 | 1223 | 43.07% | 84.22% | 41.15% |
| 12 | 45/M | 163 | 323 | 24.54% | 56.27% | 31.73% |
| 13 | 30/M | 1903 | 2263 | 47.44% | 74.24% | 26.80% |
| 14 | 35/M | 696 | 593 | 84.36% | 91.93% | 7.57% |
| 15 | 40/M | 1211 | 1057 | 80.57% | 88.09% | 7.52% |
| 16 | 36/M | 8483 | 7847 | 84.84% | 96.10% | 11.26% |
| 17 | 32/F | 195 | 611 | 12.22% | 43.39% | 31.17% |
| 18 | 34/M | 329 | 976 | 20.07% | 69.12% | 49.05% |
| 19 | 30/F | 340 | 1462 | 8.56% | 39.25% | 30.69% |
| 20 | 24/M | 591 | 2096 | 21.72% | 81.02% | 59.30% |
| 21 | 50/M | 352 | 3510 | 3.24% | 38.30% | 35.06% |
Following the application of low cost wall mounted NPWT the bacteriological count (number of bacteria/ml) decreased in 13/21 patients (61.9%) while 8/21 patients (38.1%) had an increase in the bacteriological count. The pre-NPWT application bacteriological count ranged from 3000/ml to 130000000/ml with a mean of 12616761.9/ml (SD = 29664589.37). The post-NPWT application bacteriological count ranged from 1000/ml to 380000000/ml with a mean of 26401523.8/ml. The mean increase in bacteriological count was 13784761.9/ml. However this was found to be statistically not significant (p = 0.404).
Gram staining and culture of patients pre- and post-NPWT applications have been detailed in Table 3. 17 out of 21 patients showed similar gram staining bacteria pre- and post-NPWT application in the current study.
Table 3.
Gram staining and culture.
| SERIAL NUMBER | AGE/SEX | GRAM STAIN PRE NPWT APPL | GRAM STAIN POST NPWT APPL | ORGANISM CULTURED PRE NPWT APPL | ORGANISM CULTURED POST NPWT APPL |
|---|---|---|---|---|---|
| 1 | 78/M | GNB | GNB | Escherichia coli | Escherichia coli |
| 2 | 28/M | GNB + GPC | GNB | Escherichia coli | Escherichia coli |
| 3 | 42/M | GNB | GNB | Acinetobacter baumannii | No growth |
| 4 | 18/M | GPC | GPC | Staphylococcus aureus | Staphylococcus aureus |
| 5 | 22/F | GNB | GNB | Klebsiella pneumoniae | Klebsiella pneumoniae |
| 6 | 50/M | GNB | GNB | Acinetobacter baumannii | Acinetobacter baumannii |
| 7 | 24/M | GPC | GPC | MRSA | MRSA |
| 8 | 62/M | GNB +GPC |
GNB | Escherichia coli | Escherichia coli |
| 9 | 22/F | GNB | GNB | Escherichia coli | Escherichia coli |
| 10 | 26/M | GNB | GNB | Escherichia coli + Pseudomonas aeuroginosa | Escherichia coli |
| 11 | 18/M | GPC | GPC | Staphylococcus Haemolyticus | Staphylococcus Haemolyticus |
| 12 | 45/M | GPC | GNB + GPC | Staphylococcus epidermidis + Escherichia coli | Escherichia coli |
| 13 | 30/M | GNB | GNB | Escherichia coli + acinetobacter baumannii | Escherichia coli |
| 14 | 35/M | GNB | GNB | Escherichia coli | Escherichia coli + Pseudomonas aeuroginosa |
| 15 | 40/M | GPC | GPC | Staphylococcus aureus | Staphylococcus aureus |
| 16 | 36/M | GNB | GNB | Pseudomonas aeuroginosa | Pseudomonas aeuroginosa |
| 17 | 32/F | GNB | GNB | Pseudomonas aeuroginosa | Pseudomonas aueroginosa |
| 18 | 34/M | GNB | GNB | Escherichia coli | Escherichia coli |
| 19 | 30/F | GPC | GPC | Staphylococcus aureus | Staphylococcus aureus |
| 20 | 24/M | GNB + GPC | GNB + GPC | Klebsiella pneumoniae | Klebsiella pneumoniae |
| 21 | 50/M | GNB | GNB | Pseudomonas aeuroginosa | Pseudomonas aeuroginosa |
GNB: Gram negative bacilli, GPC: Gram positive cocci, MRSA: Methicillin-resistant Staphylococcus aureus.
4. Discussion
In the current study we evaluated the change in granulation tissue coverage and bacteriological load in the wounds of patients with acute musculoskeletal injury using a low cost wall mounted negative pressure wound therapy device.
The low cost NPWT used in our study consisted of commercially available foam (sterilized by using autoclave), adhesive dressing routinely used in wards and a wall mounted vacuum suction device available in hospital wards.
Mouse et al.23 reported a significant reduction in wound size in 100% of the case undergoing vacuum assisted closure therapy. This study utilized the conventional VAC® designed by Morykwas and Argental et al.2 Similarly Nain et al.24 evaluated 30 patients and concluded that a significantly early appearance of granulation tissue was seen in the VAC group along with a decrease in wound size, which was greater than the conventional saline dressing group.
Most of the studies on NPWT used the VAC® system which, although highly effective, is costly to use and hence is difficult to use in medical setups with low economic resources. Therefore, attempts to modify VAC® system were made and a few studies reported a successful outcome. Kumar et al. utilized one such system consisting of saline gauzes and Ryle's tube for suctioning.25 They reported a mean reduction in wound size by 25.4 cm2 and development of 100% granulation tissue in wounds by end of 4 weeks.
In the current study mean increase in granulation tissue area of 716 mm2 and the mean reduction in wound size by 599.29 mm2 was comparable to the other studies, while using a much cheaper alternative to the traditional commercially available NPWT devices.
The various benefits of NPWT can be attributed to a wide variety of mechanisms of which, bacteriological clearance was claimed as one. Over the years multiple studies have been conducted to evaluate the effect of NPWT on bacteriological clearance and to this date a common consensus hasn't been reached.23,24,26, 27, 28
Moues et al. evaluated 54 patients in a comparative study and concluded that the bacteriological load did not change significantly in both the VAC® and the conventionally treated patients. However, the patients receiving the VAC therapy had significantly improved wounds thus interpreting that the beneficial effects of VAC therapy cannot be attributed to bacteriological clearance from the wound.23 However Tan et al. evaluated 70 patients in a comparative study and concluded that NPWT enhances the bacteriological clearance of infected wounds as compared to conventional saline dressing.27 The various studies concerning the change in bacteriological count following NPWT application are summarized in Table 4.
Table 4.
Studies evaluating the change in bacteriological count following NPWT application.
| STUDY | FEATURES | SAMPLE SIZE | GRANULATION TISSUE AND WOUND SIZE | REMARKS |
|---|---|---|---|---|
| Moues et al. (2004)23 | Bacterial load in relation to VAC therapy. | 54 patients 29 patients were randomized to VAC whereas 25 patients received moist gauze therapy. |
In 11 out of 26 VAC-treated wounds (42%), the biopsies taken at the end of the follow-up period contained more than 105 bacteria com- pared to 10 out of 24 conventional-treated wounds (42%). | The quantitative bacteriological load did not change significantly in both VAC and conventional therapy group.The study concluded that although VAC improves the wound, this cannot be attributed to bacteriological clearance. |
| Braakenburg et al. (2006)26 | Clinical efficacy and cost effectiveness of VAC technique in management of acute and chronic wounds. | 65 patients 32 patients were randomized to VAC therapy and 33 patients to conventional therapy. |
At the end of the therapy there was bacterial growth in 84% of wounds treated with VAC therapy compared to 58% treated with conventional therapy. | The study concluded that there was no significant reduction in positive bacterial swabs from the wound bed hence the positive attributes of VAC cannot be correlated with bacterial growth. |
| Tan et al. (2011)27 | Clinical efficacy of VAC therapy in management of adult osteomyelitis | 68 patients of which 35 of which received VAC therapy and the other 33 received conventional gauze therapy. | 29 out of the 35 patients who received VAC therapy showed negative wound cultures at the endpoint. Compared to this only 15 out of 33 patients showed the same in the conventional dressing group. |
The study concluded that NPWT enhances the bacteriological clearance of infected wounds. |
| Nain et al. (2011)24 | Role of NPWT in healing of diabetic foot ulcers | 30 patients 15 treated with NPWT 15 treated with conventional dressing |
Of patients treated with NPWT, 40% had cultures suggestive of no growth by the end of 3rd week. Compared to this only 20% showed no growth in the other group |
The study concluded that wounds treated with NPWT showed rapid clearance of bacteriological load. |
| Sinha et al. (2013)28 | VAC therapy vs standard wound therapy for acute musculoskeletal injuries | 30 patients 15 patients randomized to VAC dressing 15 patients randomized to moist saline gauze dressing |
60% of patients treated with VAC therapy showed no growth at the end of the 8th day as compared to the saline dressing group with showed only 20% of the patients with no growth. | The study concluded that there was significant decrease in the bacteriological growth in the VAC group when compared to the conventional group. |
| Current study | Evaluation of change in granulation tissue coverage and bacteriological load in acute musculoskeletal wounds using low cost NPWT | 21 patients were evaluated both pre and post application of low cost NPWT | In 13/21 patients there was a decrease in total bacteriological count whereas in 8/21 patients there was an increase in the total bacteriological count per ml after 48 h of low cost NPWT application. | The current study concluded that there was statistically no significant increase in bacteriological clearance from the wounds of acute musculoskeletal injury patients subjected to wall mounted low cost NPWT. |
Our study evaluated the bacteriological clearance of wounds following the use of low cost NPWT in 21patients. In 13/21 patients there was a decrease in the bacteriological count and in the remaining 8, there was an increase in the bacteriological count. However, all the patients showed a significant improvement in the wound following 48 h of low cost NPWT application.
As an additional parameter bacteriological species was also evaluated pre and post-NPWT application using wall mounted low cost device. 17/21 cases showed similar gram staining and microorganisms pre and post NPWT application which were predominantly gram-negative organisms. 4/21 cases showed a mixed flora either pre or post the NPWT application.
The current study showed that low cost NPWT application does not significantly influence the bacterial flora of the wound. The assessment of bacteriological clearance showed a non-significant decrease in bacteriological clearance from the wound. To the best of our knowledge no study could be found evaluating bacteriological clearance from the wound using a low cost NPWT device although multiple studies have been conducted evaluating the same using commercially available systems. Our results are comparable to many studies which state that the beneficial effects of NPWT cannot be attributed to an increased bacteriological clearance from the wound.23,26,29,30
The strengths of the current study are its prospective design and being a study of the outcomes of two parameters following a low cost NPWT application, whereas most of the previous studies were conducted with more expensive commercially available NPWT devices. However, the limitation of the current study are its small study size and absence of control group.
The current prospective interventional study concludes that there was statistically significant increase in coverage of granulation tissue and statistically significant decrease in the wound size of patients of acute musculoskeletal injury subjected to low cost wall mounted NPWT. However, there was no significant increase in bacteriological from the wounds.
Source(s) of support or funding
Nil.
Declaration of competing interest
None declared.
Contributor Information
Siddharth Pathak, Email: siddharthpathak.30@gmail.com.
Amit Srivastava, Email: amitsrvstv00@gmail.com.
Aditya N. Aggarwal, Email: dranaggarwal@hotmail.com.
Manish Chadha, Email: mchadha@hotmail.com.
Bineeta Kashyap, Email: dr_bineetakashyap@yahoo.co.in.
N.P. Singh, Email: singhanjna@yahoo.co.in.
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