PINTA - Prophylactic Incisional Negative Pressure Therapy for Major Amputations
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoyal College of Surgeons, Ireland
About this trial
Post-operative wound issues in abdominal surgery have a significant impact on patient outcomes. This study is taking place to investigate if Negative Pressure Wound Therapy (NPWT) dressings reduces Surgical Site Infections, post surgical complications and improves scar appearance compared to standard dressings.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Negative Pressure Wound Therapy
- Standard Wound Dressing
Treatment groups
728 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov