The use of autologous platelet-rich-plasma during surgery in patients with gynecological cancer improves wound healing and reduces postoperative pain feeling

ISRCTN	ISRCTN17395989
DOI	https://doi.org/10.1186/ISRCTN17395989

Submission date: 22/05/2024
Registration date: 01/07/2024
Last edited: 01/07/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Background and study aims
Oncological patients are at high risk of developing postoperative wound complications, including failure of proper wound healing (wound dehiscence), defined as complete or partial wound separation (>1 cm long). Platelet-rich plasma (PRP) is a concentrate of plasma rich in platelets derived from whole blood, centrifuged to remove red blood cells. It has a higher concentration of growth factors than whole blood and is widely used in regenerative medicine to encourage the healing of bone and soft tissues. The use of PRP may also reduce pain in the postoperative period. This study aims to evaluate the impact of PRP application during surgical treatment on wound healing and pain intensity feeling in patients with gynecological cancers (ovarian, endometrial or cervical cancer).

Who can participate?
Adult patients aged >18 years old diagnosed with gynecological cancers (ovarian, endometrial or cervical cancer) qualified for surgical treatment by laparotomy (a surgical procedure that involves making an incision through the abdominal wall to gain access into the abdominal cavity)

What does the study involve?
The study involves the application of PRP or placebo (saline infusion) into the wound during a surgical procedure. Patients included in the study are unaware of what kind of intervention they receive – PRP or placebo. After surgery, patients are asked to assess pain intensity by fulfilling appropriate questionnaires (immediately after surgery, 6 and 12 hours after surgery). Patients are also asked to come for follow-up visits and fulfill additional questionnaires regarding scar quality and quality of life assessment on days 1, 8, 30 and 90 after surgery.

What are the possible benefits and risks of participating?
The possible benefit of participation in this study is an improvement in wound healing and a reduction in pain intensity after surgery. Platelet-rich plasma or placebo application is performed under anesthesia during the abdominal wall closure, thus it doesn’t cause any additional pain or discomfort for the patient. The procedure needs blood sample collection, but it can be performed during routine preoperative blood testing. The use of PRP is safe because it is derived from the patient’s blood – therefore there is no risk of allergic reactions either during the first or subsequent applications.

Where is the study run from?
The study is run by the Department of Obstetrics, Women’s Diseases and Oncogynecology, National Medical Institute of the Ministry of the Interior and Administration in Warsaw, Poland

When is the study starting and how long is it expected to run for?
June 2016 to December 2019

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Tadeusz Issat, tadeusz.issat@imid.med.pl

Contact information

Prof Tadeusz Issat
Public, Principal Investigator

Kasprzaka 17a
Warszawa
01-211
Poland

ORCID ID	0000-0002-3647-3550
Phone	+48223277044
Email	tadeusz.issat@imid.med.pl

Dr Katarzyna Pankiewicz
Public, Scientific

Kasprzaka 17a
Warszawa
01-211
Poland

ORCID ID	0000-0001-7756-1963
Phone	+48223277044
Email	katarzyna.pankiewicz@imid.med.pl

Study information

Study design	Single-center single-blind placebo-controlled interventional study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet.
Scientific title	The application of autologous platelet-rich-plasma during laparotomy in patients with gynecological malignancies improves wound healing and reduces postoperative pain feeling – a single-blind placebo-controlled intervention study (preliminary report)
Study hypothesis	Platelet-rich plasma (PRP) application into the wound during surgery in gynecological cancer patients improves wound healing and reduces pain in the postoperative period
Ethics approval(s)	Approved 09/11/2016, The Bioethical Committee of Central Clinical Hospital of Interior in Warsaw (Wolska 137, Warsaw, 02-507, Poland; +48 47 722 15 52; komisja.etyki@cskmswia.gov.pl), ref: 99/2016
Condition	Gynecological cancer
Intervention	Adult women undergoing surgical treatment because of female genital tract malignancies are included. Patients are randomly assigned to one of the two different groups: Group 1 will receive an application of platelet-rich plasma (PRP) and Group 2 (control group) will receive an application of placebo (0,9% NaCl solution) into the wound during the surgery. The allocation ratio is 1:1 and it is supervised by an independent clinician, who is not involved in the PRP application during surgery. The randomization is performed manually and the allocation concealment is performed by using sequentially numbered opaque envelopes. Surgical treatment is performed by laparotomy with the midline incision in all patients. Surgical procedures include bilateral salpino-oophorectomy, total abdominal hysterectomy with bilateral salpingo-oophorectomy, radical hysterectomy with pelvic lymph node assessment and ovarian cancer full protocol. At the end of the surgery, during the abdominal closure, PRP or a placebo (0.,9% NaCl solution) is applied by a series of microinjections into the abdominal muscles fascia, as well as into the subcutaneous tissue. All patients receive antibiotic prophylaxis with a single dose of 2g cefazolin administered intravenously up to 20 minutes before skin incision. All patients have general anesthesia during the procedure. After the surgery, all patients are treated with analgesics. The basic therapy is intravenous paracetamol and morphine administered in the form of patient-controlled analgesia (PCA). Additionally, some patients are treated with intravenous metamizole or ketoprofen, when needed.
Intervention type	Biological/Vaccine
Pharmaceutical study type(s)	Not Applicable
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Autologous platelet-rich-plasma
Primary outcome measure	Wound dehiscence, defined as both complete and partial wound separation (>1 cm long) diagnosed by the clinician during the follow-up period
Secondary outcome measures	1. Postoperative pain intensity measured using a Visual Analogue Scale (VAS) immediately after the surgery, 6 and 12 hours after the surgery 2. Analgesic use after surgery in the early postoperative period measured using data collected in patient medical records, defined as the mean and total number of morphine boluses needed, the number of doses of paracetamol, metamizole and ketoprofen needed per one-day 3. Scar quality assessment measured by the Patient and Observer Scar Assessment Scale (POSAS) recorded on days 1, 8, 30 and 90 after surgery by both patient and clinician 4. Quality of life assessment after surgery measured using the 12-Item Short Form Survey (SF-12) on days 1, 8, 30 and 90 after surgery
Overall study start date	01/06/2016
Overall study end date	31/12/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target number of participants	23 patients in the study group; 23 patients in the control group
Total final enrolment	46
Participant inclusion criteria	1. Aged > 18 years 2. Diagnosis (or suspicion) of gynecological malignancy (ovarian, endometrial or cervical cancer) with the qualification for surgical treatment by laparotomy
Participant exclusion criteria	1. Allergy for analgesics 2. Viral or bacterial local infections, coagulation disorders 3. Body mass index (BMI) > 40 kg/m2 4. Lack of consent for the study enrollment
Recruitment start date	01/01/2018
Recruitment end date	31/05/2019

Locations

Countries of recruitment

Poland

Study participating centres

Department of Obstetrics, Women’s Diseases and Oncogynecology

National Medical Institute of the Ministry of the Interior and Administration in Warsaw
Wołoska 137
Warszawa
02-507
Poland

Department of Obstetrics and Gynecology, Institute of Mother and Child

Kasprzaka 17a
Warszawa
01-211
Poland

Sponsor information

National Medical Institute of the Ministry of the Interior and Administration
Hospital/treatment centre

Woloska 137
Warsaw
02-507
Poland

Phone	+48 47 722 15 52
Email	ginekologia@cskmswia.gov.pl
Website	http://mib.gov.pl/

Instytut Matki i Dziecka
Hospital/treatment centre

Kasprzaka 17a
Warszawa
01-211
Poland

Phone	+48223277044
Email	klinika.poloznictwa@imid.med.pl
Website	https://icmh.org.bd/
"ROR"	https://ror.org/03v4km086

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	31/12/2024
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a peer-reviewed journal
IPD sharing plan	The datasets generated during and/or analysed during the current study will be available upon request from Katarzyna Pankiewicz, e-mail: katarzyna.pankiewicz@imid.med.pl Available for institutional review board-approved individual patient data meta-analysis 12 months after publication.

Editorial Notes

23/05/2024: Study's existence confirmed by the Bioethical Committee of the Central Clinical Hospital of Interior in Warsaw.