Health-Related Physical and Mental Quality of Life After Non-Traumatic Lower Extremity Amputation Using Incisional Negative Pressure Wound Therapy: A Randomized Controlled Trial
Christopher M. Ply*, Holly D. Shan, Samuel S. Huffman, Ryan Braun, John Steinberg, Stephen Baker, Christopher Attinger
Plastic Surgery, Georgetown, Washington,
Incisional negative pressure wound therapy (iNPWT) has shown to reduce complication rates and decreased time to prosthesis after LEA, therefore improving ambulation and functional independence. It is important to understand whether this avenue of wound healing post-surgery can influence mental and physical-related QoL. The purpose of this study is to explore if QoL in non-traumatic LEA recipients differs between patients receiving iNPWT compared to standard dry dressing.
Patients undergoing a non-traumatic LEA were randomized to receive either iNPWT (3-M Prevena, Ireland) or a standard dry dressing. Patient demographic data was obtained through chart review. The Medical Outcomes Study 12 Short Form Health Survey (SF-12) was given before surgery (entry) and at a 90-day follow-up appointment (exit); individual items were scored as well as divided into physical component summary (PCS) and mental component summary (MCS). Data analysis was performed using STATA version 17.0 with statistical significance set at values of p<0.05. Results were reported as (Dry dressing vs. iNPWT).
A total of 108 patients were chosen for participation and randomized to 54 per group; 8 patients were lost to follow-up and removed from the study. Within the individual SF-12 items, patients reported a significantly higher general health score post-LEA (3.24 ± 0.84 vs. 2.28 ± 0.89, p=0.039). The iNPWT cohort had an increase PCS while the dry dressing reported a decrease in PCS (0.68 ± 0.41 vs. -0.77 ± 0.57, p=0.043). MCS decrease post-LEA in both groups and did not differ in magnitude (-5.13 ± 1.04 vs. -4.02 ± 1.22, p=0.46).
Lower extremity amputation is an invasive physical procedure that may have many physical and mental implications, so it is not surprising that literature reports decreased QoL post-LEA. In combination with our prior findings from this pilot study that iNPWT may reduce time to use a prosthesis, this study found that iNPWT patients reported improved physical functioning compared to the dry dressing cohort, with no difference in health-related mental health.
SF-12 Questionnaire with Physical and Mental Component Summary and Change in Scores
| Dry Dressing (n=51) | iNPWT (n=49) | P-value | |
| Physical Component Summary Entry Score | 7.02±1.99 | 6.64±1.53 | 0.30 |
| Mental Component Summary Entry Score | 13.2±3.68 | 12.68±3.18 | 0.46 |
| Physical Component Summary Exit Score | 6.41±2.41 | 7.08±2.80 | 0.28 |
| Mental Component Summary Exit Score | 8.16±4.73 | 8.52±5.62 | 0.76 |
| Change in SF-12 Physical Component Summary | -0.77±0.57 | 0.68±0.41 | 0.043* |
| Change in SF-12 Mental Component Summary | -5.13±1.04 | -4.02±1.22 | 0.46 |
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