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Introduction

Maternal obesity increases a woman’s risk of developing a surgical site infection following caesarean section. ¹ Surgical site infection (SSI) after caesarean section is common and ranges between 3%–15% worldwide.² The presence of SSI post caesarean section increases a woman’s risk of maternal morbidity and mortality,^3,4 and can be challenging for the mother trying to self-manage her recovery and care for a newborn.⁵ Further, SSI can contribute to prolonged maternal hospitalisation, increased health care costs, and other socioeconomic implications.⁶

In recent years, the use of prophylactic incisional negative pressure wound therapy (iNPWT) has emerged as a key strategy to reduce the risk of wound complications and promote healing of closed surgical incisions, especially after caesarean section surgery.⁷ In this context, iNPWT is applied over a closed incision that has been secured with sutures or staples and then sealed with a semi-occlusive adhesive dressing connected to a portable suction pump. Also known as vacuum-assisted wound closure, iNPWT involves a non-invasive system that applies localised negative pressure between -50mmHg and 125mmHg to the wound surface. The mechanism of this device works by pulling the wound edges together and improving microvascular blood flow, thereby facilitating wound healing.⁸ A growing body of literature has examined the potential role of incisional negative pressure wound therapy (iNPWT) in reducing surgical site infections (SSI) after caesarean section. However, results are mixed. While some studies show modest benefits, others report minimal or no advantage. A recent meta-analysis reported a number needed to treat (NNT) of 58 to prevent one superficial SSI, raising questions about the broad clinical value of iNPWT.⁹ Therefore, it is important to understand how patients experience iNPWT, particularly, those who may not derive a measurable clinical benefit.

Given that women are required to manage the iNPWT independently after hospital discharge, it is essential to understand their experience of using this device in real-world contexts. While the technology has become more compact and portable, little is known about how women perceive and navigate its use during daily activities. Existing research has largely centred on clinical outcomes, yet the experiential dimensions, such as comfort, usability and acceptability remain unexplored. Recent studies have begun to examine patient reported outcomes (PROMs) associated with iNPWT, including scar quality and patient experience,¹⁰ providing additional context for interpreting patient perceptions. Understanding these factors is increasingly recognised as a priority in the design and development process of medical devices¹¹ as end-user feedback can influence design improvements, patient safety,¹² and engagement.^11,13 This study does not evaluate clinical effectiveness but aims to address this gap by exploring the acceptability, usability and the perceived experience of using iNPWT among women following caesarean birth.

Methods

Study design

This exploratory qualitative interview study was conducted as part of a larger, multi-site randomised controlled trial (RCT), to provide an in-depth description of the perceptions of women with obesity regarding the use the iNPWT dressing. This design was appropriate as it provides a deeper understanding of the phenomenon of interest and allowed the researchers to understand the world from the participants’ perspectives.¹⁴ The results of the parent RCT have been published elsewhere.²³ In the parent RCT, pain and wound healing were assessed through patient self-report and clinical evaluation by an independent outcome assessor for SSI. No validated quantitative instruments were used to measure comfort or wound appearance. Data for this qualitative component were collected as part of the parent RCT; however, analysis and publication were undertaken following completion and reporting of the main trial outcomes.

Setting and sample

The study setting was a 153-bed maternity hospital in Australia that delivers about 10,000 babies and performs 4000 caesarean births annually. The parent trial screened 12,077 women, 2035 of whom were randomised to receive either iNPWT (n=1017) or standard dressing (n=1018). Women were eligible if they had a pre-pregnancy BMI≥30, were aged 18 or older, and were scheduled for an elective or urgent caesarean section. Women showing signs of infection were excluded. In some clinical cases, obstetricians were permitted to override randomisation based on clinical judgement, and these cases were documented as randomised but not treated. In this study, a subsample of women from the larger multi-site RCT was included. Women were eligible to participate if they: (1) received the iNPWT dressing in the parent trial and (2) were able to provide written consent. Participants were purposefully selected to ensure maximum variation relative to age, BMI and parity.

To minimise bias, the researchers who selected participants for the qualitative study had no access to their clinical outcomes, such as surgical site infection (SSI), at the time of selection. The higher proportion of elective caesarean sections (17 out of 20 participants) reflected the distribution of the parent trial, in which approximately 73% of enrolled women underwent elective caesarean sections.²³

Intervention

The PICO™ single use NPWT (Figure 1) ¹⁵ was the intervention dressing women received in the parent trial. The dressing, connected by tubing to a small portable suction pump, exerts a continuous negative pressure of 80mmHg and acts to remove exudate from the wound bed through absorbency and evaporation.¹⁶ The duration of therapy for the women enrolled was between five and seven days according to the manufacturer’s recommendations. The iNPWT carton provided to the women contained an additional dressing complete with fixation tape for the women to change the dressing, if necessary.

 

Figure 1. iNPWT with tubing and suction pump¹⁵

 

Ethical considerations

We obtained ethical approval from the hospital and university research ethics committees prior to study commencement (HREC/15/QRBW/126) and (GU Ref No: NRS/28/15/HREC). After a full explanation of the study, informed written consent was obtained during recruitment and participants were informed that they may be selected for a telephone interview. Consent was renegotiated with participants randomised to the iNPWT arm before the telephone interviews. This study adheres to the Consolidated Criteria for Reporting Qualitative Research (COREQ).¹⁷

Data collection

We collected data through semi-structured telephone interviews conducted two weeks post-discharge following caesarean section. This timeline allowed the women to reflect on their use of iPNWT following completion of therapy. Interviews took place between February 2019 and October 2019. Telephone interviews were selected as they were cost-effective and conducive to free-flowing information.^18,19

Participants were asked five open-ended questions about their perceived experiences using the iNPWT dressing, guided by an interview guide (Appendix 1), which was informed by literature and pilot tested for clarity and relevance. Interviews ranged from three to seven minutes in duration. Despite their brevity, the interviews yielded consistent and thematically coherent data. Data sufficiency was observed after 12 interviews, with no new insights emerging. However, we interviewed an additional eight participants to ensure demographic variation (age, BMI, parity) and to confirm thematic saturation, consistent with principles of maximum variation.²⁰

Demographic data, including age, BMI, comorbidities, parity, gravidity and the number of previous caesarean sections, were collected by chart audit before the interviews. Other quantitative data collected from the parent trial included the change of dressing and satisfaction with the allocated dressing. The research assistant conducting the interviews was a trained midwife with several years of research experience. Any unclear information was clarified with the participants to avoid misconceptions. All interviews were audio recorded and transcribed verbatim, and all identifiable information, was removed.

Data analysis

We analysed quantitative data (demographic/clinical characteristics) using Statistical Package for Social Sciences (SPSS) version 25 (IBM Corp. SPSS Version 25. Armonk, NY). An embedded mixed-methods approach to content analysis was adopted.²¹ Qualitative content analysis was initially conducted to identify categories and subcategories, followed by quantitative analysis to quantify these categories and subcategories. The qualitative findings provided valuable insights into the context and subjective experiences, while the quantitative analysis complemented the qualitative findings by providing numerical evidence. As part of this process, a research assistant listened to each recording and read the transcripts for immersion in the data. Codes that were directly derived from verbatim statements were initially mapped across the five structured questions and then abstracted into subcategories and categories based on common concepts identified in the data. Evaluation of data sufficiency involved examining the qualitative findings alongside the aims of the study, the uniqueness of participants’ experiences, and the quality of the interviews. An electronic audit trail was reviewed by two researchers. The analysis was an iterative process, with the researchers constantly referring to the raw data to substantiate emerging ideas and categories. The labelling of categories/subcategories was discussed among the researchers until consensus was reached.

Rigor

Trustworthiness of this study relative to credibility, transferability, dependability and confirmability was upheld using several strategies.²² Credibility of the analysis was enhanced using constant comparative analysis among the researchers. The findings were taken back to the research midwife who interviewed the participants to check that findings reflected what participants said, supporting the credibility of the findings. The use of maximum variation in sampling increased the conceptual transferability of findings, and we have described the setting/contents to allow readers to assess whether these findings are transferable to their context. Dependability was ensured by maintaining memos throughout data analysis to document analytical decisions and the use of direct quotes from participants to support findings. Finally, investigator bias was minimised by having a researcher with a background in dietetics (versus midwifery or nursing) lead data analysis, increasing the confirmability of findings.

Results

Twenty women participated in the interviews. The average age of the participants was 32 years (SD=4.2, range 27–41 years), and the mean pre-pregnancy BMI was 35.1 (SD=5.5). Most women (80%) had a pre-pregnancy BMI of 30.0 to 39.9kg/m-squared. One participant had a pre-pregnancy BMI greater than 50, but her experience did not differ notably from the rest of the cohort in terms of comfort, usability, or satisfaction with the dressing. Ten (50%) women had had at least one caesarean section previously. Seventeen (85%) caesarean sections were planned. All women were somewhat or completely satisfied with the iNPWT dressing, with 11 women (55%) reporting being somewhat satisfied and 9 women (45%) being completely satisfied. None of the women required a change of dressing after their caesarean section, and one of them developed a SSI. Participants’ demographic data is summarised in Table 1. Their perceptions of using the iNPWT dressing were grouped into three categories and 11 subcategories (Table 2).

 

Table 1. Demographics information (n=20)

 

Table 2. Categories and subcategories

 

Wearing the iNPWT dressing

Women described their experience of wearing the iNPWT dressing in relation to comfort, tightness and perceived functional or sensory benefits. Overall, participants were satisfied with the dressing’s comfort; none reported it as uncomfortable to wear. Several women described it as “really comfortable”, with two adding that they were “pleasantly surprised” as they had expected “a bit more pain in the beginning”. However, somewhat diverse views were expressed regarding the level of tightness around the lower abdomen. A few women reported that it felt tight around the lower abdomen during the first three days, which limited their mobility. In contrast, five others who had previously undergone caesarean sections perceived the tightness positively, describing it as “feeling firm” and offering a sense of abdominal “support” that improved their comfort and mobility. Additionally, several participants said they were “not really aware” of the dressing or compared it to “wearing any other dressing,” which they viewed favourably. Most women compared the iNPWT dressing to a previous caesarean section dressing experience(s). Some preferred their current experience using the iNPWT dressing due to perceived functional and/or sensory benefits. Compared to previous caesarean sections, these women felt more reassured, considering the dressing “would beep” if something was possibly wrong. Others perceived that the iNPWT dressing provided greater support, enhanced mobility, reduced pain while wearing it and/or upon removal, and/or required fewer changes. Although not explicitly framed as anxiety-reducing, several women conveyed a sense of relief, support or reassurance, particularly in contrast to past caesarean recoveries, where they felt more discomfort or vulnerability. One woman shared, “With the pump on over the days I didn’t notice it and I was getting in and out of bed a lot easier … I struggled getting out of hospital [last time] … But with the PICO dressing I was a lot more — what’s the word? It didn’t affect me at all.” (P11).

Managing iNPWT dressing accessories

While all participants expressed general satisfaction with wearing the iNPWT dressing itself, many described challenges in managing its accessories (such as the pump [including battery], cords, storage pouch and sling). These issues affected their ability to perform daily activities such as toileting, showering, sleeping, and breastfeeding. About 11 women (55%) reported mild difficulty with these routine tasks. Two participants found sleeping difficult, either because they inadvertently lay on the device or the pump disconnected during the night. Another two women noted that the cord would “get caught up” while breastfeeding, making the process cumbersome.

Women responded to these inconveniences in two ways: by adapting to the limitations through creative adjustments and by offering recommendations for future improvements. Despite these challenges, their feedback underscores the importance of addressing accessory-related usability issues to support everyday function during postnatal recovery.

A common topic discussed by the women was how they adapted or managed the iNPWT accessories while performing activities of daily living. Many perceived performing tasks such as showering/toileting as difficult because they had to “try to keep the pump dry” or “remember to carry it”. For example, three women stated that they disconnected the pump from the dressing to have “a bit of freedom” or because they “didn’t have anywhere to hang it” at home while showering/toileting. Others spoke of using a plastic bag (n=1), or the sling and pouch provided to hang it up (n=2) to prevent the pump from getting wet.

Clothing and accessory choices also played a role in managing the device. To facilitate movement, women commonly used the sling and pouch, wore clothing with pockets (n=4), or placed the pump inside their underwear. In three cases, women resorted to using underwear due to the pouch or sling breaking or not receiving one initially. One participant preferred this method over using the pouch.

“I just always made sure I had clothing with pockets in it at least so I can pop it in the pocket. Just with getting in the shower … popping it in a little plastic bag and making sure it didn’t get wet …” (P17).

Feedback about the sling and pouch varied. Two women suggested alternatives such as an elastic belt or a neck lanyard or clip for better support. Others found the provided accessories helpful and recommended using them during mobility or while showering. Similarly, opinions about the size and length of the pump and tubing ranged from being “too bulky” to “a good size/length” that fit in a pocket or could be hung up. Despite the mixed feedback, it was clear that wearability and convenience were key considerations in how women navigated daily life with the iNPWT system.

Removing the iNPWT dressing

Women described their experiences of dressing removal in relation to pain, comfort, and wound appearance. All participants unanimously reported minimal to no pain during the removal process itself, with some describing it as a “pleasant surprise”. However, a few reflected on how they felt in the hours or days following removal. Two women felt relieved and “more comfortable not wearing it”, while others perceived the dressing as providing physical support. For instance, three participants experienced mild soreness after removal and associated this with the absence of support: “As soon as I took it off, I didn’t do too much. I said to my mum and my partner, I want to put it back on … because the pain wasn’t as bad. I got a little tiny bit of pain after taking it off, but other than that, yeah, it was really, really good.” (P12).

This discomfort was generally short-lived, and most women reported feeling “fine after a few days”. One woman only realised on Day 7 that the pump had stopped working when she woke up sore, reinforcing her belief in the dressing’s supportive function.

Some women also commented on the wound’s appearance post-removal. Two were highly satisfied and recommended the dressing for routine use, citing excellent healing and scar condition: “I think everyone that has a caesarean should have that dressing, because I had no dramas at all — after I had my caesarean, I had it taken off a week later, my caesarean scar has been absolutely perfect, it’s healed really, really well.” (P15).

Others gave neutral feedback or did not specifically mention scar appearance. However, three women reported that their general practitioners were impressed with the wound’s condition, using the terms “surprised”, “amazed” or “impressed” with the wound condition.

Receiving iNWPT information

Women discussed the methods used to communicate iNWPT dressing-related information frequently using terms like “clear” and “concise” to enhance verbal instructions. Several also found the written fact sheet useful for enhancing comprehension. Overall, women expressed satisfaction with the content of the information provided, describing it as “accurate”, and most agreed it was sufficient. They found the guidance useful for managing the device, including instructions on how the suction system worked and where to store the pump:

“I was given plenty of information and plenty of knowledge with regard to the dressing and how to look after it … so it was all really informative.” (P17).

Some women recalled receiving information about the potential benefits of using the iNPWT device, such as facilitating the healing process, which they valued.

“The information that I was given, told me how this was going to benefit the healing of my wound and obviously how it was going to benefit other people in the study and the trial … what they [gave me] — was definitely enough.” (P13).

Discussion

While there has been an increased use of portable iNPWT in wound management for women undergoing caesarean birth,^23,24 there has been limited research on the usability or user experience of the dressing for these women. Our study is one of the first qualitative studies to provide an in-depth exploration of end-users’ experience of using iNPWT after caesarean birth. Our findings suggest that women generally reported satisfaction with the process and experience of wearing the dressing, though this ranged from somewhat to completely satisfied. This satisfaction was often linked to the comfort of the dressing itself; however, participants also described the need to adapt and manage the accessories to minimise potential challenges. Removal of the iNPWT dressing was commonly described as painless, and several women expressed satisfaction with the appearance of the wound. Information provided about the dressing’s function and benefits was viewed as simple, concise and easy to understand. These insights may help inform improvements in patient education and device usability.

Challenges using the iNPWT dressing

Many of the early drawbacks of NPWT devices, such as a large, bulky canister, have been addressed in recent years and replaced with portable and disposable versions. However, we also identified some challenges in using iNPWT, indicating that further refinement is required. The transition from hospital to home after a caesarean section with a newborn can be challenging for women, and having to manage the iNPWT dressing with a small suction pump can be burdensome. For example, several women described the portability of the device as an important aspect of usability. Yet, they also reported that the long tubing connected to the portable battery pump interfered with essential tasks such as breastfeeding, showering or using the toilet. To minimise this inconvenience, some women resorted to creative solutions such as either disconnecting the pump or using a small disposable bag to prevent the pump from getting wet when showering. Consistent with previous studies, our participants also perceived the suction tubing attached to the canister as a potential hazard that restricted mobility and increased the risk of falls.^25-27 Although the single use iNPWT dressing may be easier to manage in comparison to the traditional NPWT, ²⁸ several recommendations were offered for improving the iNPWT, focused on issues around its wearability and managing the dressing and associated tubing. Future directions for developing the device should include modifications to increase ease of use.

Clinical benefits of using the iNPWT dressing

Notably, our qualitative study explored women’s perceptions and was not designed to assess clinical outcomes or compare dressing types. The findings reflect subjective experiences, which may nonetheless inform considerations around device design and patient-centred care.

Our findings suggest that women generally had a positive experience using iNPWT following caesarean birth. Several participants perceived benefits associated with the dressing, including comfort and ease of removal. Some women described experiencing minimal pain during dressing wear and removal, which they found reassuring. Wound care procedures such as dressing changes can cause significant pain and discomfort for patients,²⁹ and poorly controlled incisional pain can heighten stress and anxiety, negatively impacting physical and psychological well-being.³⁰ Pain may also interfere with the physiological processes involved in wound healing.^31,32 While these effects were not directly assessed in our study, they provide an important context for understanding why some participants may have appreciated the five to seven day iNPWT therapy, which eliminates the need for frequent dressing changes. For women who experience discomfort during dressing removal, this could hypothetically be a more acceptable and less distressing approach.

A few women also noted perceived improvements in wound healing and the appearance of their scar. One of the potential mechanisms of iNPWT includes continuous removal of fluid, physical splinting of the surgical site and reduction of tension across the incision to promote wound healing.⁸ Although evidence supporting the use of iNPWT remains contested despite several large RCTs undertaken,^23,24 a recent systematic review and meta-analysis of existing RCTs concluded that iNPWT may reduce superficial SSI in comparison with standard dressings in this patient cohort.⁹

Patient education improves end-user engagement

The success of a clinical device in delivering its promised outcomes largely depends on the end user’s ability to operate the device according to the manufacturer’s instructions.¹³ Although the design of the iNPWT was uncomplicated, women had to adhere to certain steps to ensure appropriate usage of the dressing. Hence, ensuring end-user ‘buy in’ early is essential to achieve adherence to the therapy.³³ In our study, the general feedback on the education of dressing change and troubleshooting the iNPWT device was positive. It is possible that increased knowledge of the mechanism of the iNPWT from the education given by clinicians and research midwife was central to the women feeling confident and in control of their incisional wound management. Additionally, understanding the potential benefits of the iNPWT dressing was perhaps a key enabler in the women’s postoperative recovery, as they were well-informed of their recovery. Having a sense of control is essential for women to effectively engage in postoperative recovery after caesarean section and to maintain treatment adherence to promote wound healing.³⁴

Limitations

There were several limitations with our study. First, the women included were from a single institution study, and it is possible that perceptions of these women may not be transferable to other sites. However, women in this study were selected using maximum variation sampling based on age, BMI and parity. Secondly, the positive rapport built between the interviewer and participants may have encouraged openness but also introduced a degree of social desirability bias, with women possibly less inclined to share negative experiences. Although the interviewer was an experienced midwife not involved in data analysis or interpretation, her professional role and relationship with participants may have created a perceived power dynamic that constrained full disclosure. Finally, most interviews were very short, ranging from three to seven minutes. This may have limited the depth of responses, although the consistency of feedback and systematic approach to analysis suggest data sufficiency was achieved. A strength of this study is that many participants had prior experience with caesarean birth and wound healing, which provided a useful point of comparison when reflecting on their experience with the iNPWT dressing.

Conclusions

Overall, the women in this study reported a generally positive experience wearing the iNPWT dressing, despite some adjustments required in their daily routines. While post-caesarean recovery posed challenges, many participants perceived that using iNPWT contributed positively to their sense of recovery and comfort. An understanding of end-users’ experiences and incorporating their feedback is essential to identify areas for improvement, enhance users’ satisfaction, and support safer use in future applications.

Conflict of interest

The authors declare no conflicts of interest.

Ethical Approval

The study was approved by the ethics committees of the Royal Brisbane and Women’s Hospital and Griffith University. (HREC/15/QRBW/126) and (GU Ref No: NRS/28/15/HREC).

Funding

This study was funded by the Australia National Health and Medical Research Council project grant APP1081026.

Trial registration

ANZCTR identifier 12615000286549.

Acknowledgements

The authors acknowledge the help of Ms Teoni McHale who conducted the interviews.

Consent

Informed written consent was obtained from patients prior to the start of the study.

Author contributions

All authors made substantial contributions to the conception and design of the study, analysis and interpretation of data, and drafting and critical revision of the manuscript. All authors approved the final manuscript and agree to be accountable for all aspects of the work.

Author(s)

Evelyn Kang*^1,2, Megan Rattray⁴, Wendy Chaboyer^2,3, Kassam Mahomed⁶, David Ellwood^7,9, Sailesh Kumar^5,8, Vicki Clifton⁵, Brigid M Gillespie^2,3,9
1Faculty of Health Science, Higher College Technology, Abu Dhabi, UAE
²School of Nursing and Midwifery, Griffith University, Brisbane, Australia
³NHMRC Centre of RE in Wiser Wound Care, Menzies Health Institute Queensland, Griffith University, Gold Coast, Australia
⁴Flinders University, College of Medicine & Public Health, Adelaide, South Australia
⁵Mater Research Institute, University Queensland, Brisbane, Australia
⁶Ipswich Hospital, Ipswich, Australia
⁷School of Medicine and Dentistry, Griffith University, Brisbane, Australia
⁸Mater Mother’s Hospital, Brisbane, Australia
⁹Gold Coast Hospital & Health Services, Gold Coast, Australia

*Corresponding author email e.kang@griffith.edu.au

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