PINTA - Prophylactic Incisional Negative Pressure Therapy for Major Amputations

Launched by ROYAL COLLEGE OF SURGEONS, IRELAND · Aug 29, 2023

Keywords

ClinConnect Summary

The PINTA clinical trial is studying a special type of dressing called Negative Pressure Wound Therapy (NPWT) to see if it can help patients who have major amputations, like below-knee or above-knee surgeries. This dressing is designed to reduce the risk of infections and other complications after surgery, as well as improve the appearance of scars compared to regular dressings. The trial is currently looking for participants who are at least 18 years old and will be undergoing a major lower extremity amputation with a proper closure of the surgical site.

If you or a loved one is eligible and chooses to participate, you can expect to be randomly assigned to either the NPWT group or the standard dressing group after your surgery. The study aims to gather information on how well NPWT works in preventing infections and improving healing. It’s important to note that certain patients, like those under 18, pregnant women, or those with specific types of amputations, won't be able to join this trial. Participating could contribute to important research that may benefit future patients undergoing similar procedures.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients aged 18 years or older;
• • Patients undergoing major lower extremity amputation, including below-knee amputation, through-knee amputation and above-knee amputation, for any indication;
• • Patients with primary closure of the surgical incision using either interrupted or continuous sutures
• Exclusion Criteria:
• • Patients \<18 years;
• • Women who are pregnant and/or breast-feeding;
• • Patients with amputations performed without primary skin closure, including guillotine amputations, amputations deliberately left open for drainage purposes and amputations with soft tissues defects at the stump;
• • Patients with amputations where skin glue is the only means of skin closure
• • Patients with a clinically absent femoral pulse