Combined Hemostasis and Adhesion Prevention with the Novel Agent 4DryField^® PH—Initial Observations

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Surgical Science, 2014, 5, 533-539
Published Online December 2014 in SciRes. http://www.scirp.org/journal/ss
http://dx.doi.org/10.4236/ss.2014.512081
How to cite this paper: Korell, M. (2014) Combined Hemostasis and Adhesion Prevention with the Novel Agent 4DryField®
PH—Initial Observations. Surgical Science, 5, 533-539. http://dx.doi.org/10.4236/ss.2014.512081
Combined Hemostasis and Adhesion
Prevention with the Novel Agent
4DryField® PH—Initial Observations
Matthias Korell
Department of Gynecology, Johanna-Etienne-Hospital, Neuss, Germany
Email: m.korell@ak-neuss.de
Received 23 September 2014; revised 20 October 2014; accepted 20 November 2014
Academic Editor: Vahit Ozmen, Istanbul University, Turkey
Copyright © 2014 by author and Scientific Research Publishing Inc.
This work is licensed under the Creative Commons Attribution International License (CC BY).
http://creativecommons.org/licenses/by/4.0/
Abstract
Large size peritoneal trauma from extended surgery for high-grade expansive uterus pathology or
endometriosis might result in severe diffuse bleeding and peritoneal adhesion formation with ob-
jectionable sequelae. This paper introduces 4DryField® PH polysaccharide powder certified for
two indications: 1) given as powder 4DryField® PH provides hemostasis; 2) transformed into gel,
4DryField® PH forms an adhesion prevention barrier. Twenty-one women with expanded uterus
pathology and/or deep infiltrating endometriosis had surgery including repair of intestine lesions
(n = 8), ureterolysis/repair of bladder, including retrograde ureteric stents (n = 5). Subjective im-
pression of hemostatic effect, drain loss and infection parameters were recorded. Six women had
scheduled second look laparoscopy. 4DryField® PH applied as powder showed an immediate sig-
nificant hemostatic effect in all instances, especially in profound diffuse bleeding. Mean drain loss
was 497 ± 339 mL, moderate considering the extent of disease. Dripped with saline solution, 4Dry
Field® PH immediately formed a viscous gel acting as a barrier for adhesion prevention. Second
look laparoscopy revealed only one patient with significant adhesions. No adverse events were
observed; discharge was at Day 6.2 ± 1.4. In this cohort with extended gynecological laparoscopic
surgery 4DryField® PH was very effective for hemostasis. The results of second look laparoscopies
showed mainly no or minor adhesions. This can be considered very favorable regarding the extent
of disease in these patients. Considering the twofold effect in hemostasis and adhesion prevention,
4DryField® PH is a very helpful tool especially in extensive and complicated surgeries. Prospective
randomized studies are necessary to prove these promising results in larger series.
Keywords
Hemostasis, Adhesion Prevention, Polysaccharide, Gynecological Surgery

M. Korell
534
1. Introduction
Although procedures like hysterectomy or resection of endometriosis are generally considered safe, they are as-
sociated with several possible complications of which Infection and hemorrhage are reported to be the most fre-
quent early ones [1]-[4].
In further course, adhesion formation must be regarded as the most common complication occurring after 60% -
90% of procedures [5]-[7]. Adhesions are responsible for a long list of sequelae ranging from the most frequent
one, i.e. persistent pelvic pain, to the most frightening one, i.e. small bowel obstruction [5]-[8].
If surgery of endometriosis is necessary for treatment of infertility there is the dilemma that the surgical in-
tervention might induce adnexal adhesions, which are an even more frequent cause for secondary female infer-
tility than endometriosis.
4DryField® PH is a novel agent certified for both hemostasis and adhesion prevention. It is purely plant-based
4DryField® PH and consists of polysaccharide particles which have a high capability to absorb water. This pro-
vides a twofold effect:
1) Taking up water from wound blood leads to concentration of coagulation factors and blood cells, which
accelerates the clotting enhancing hemostasis [10].
2) 4DryField® PH particles and fluid form a gel which is highly effective as a barrier against adhesion forma-
tion. The noticeable anti-adhesive properties of 4DryField® PH have been demonstrated in animal experiments
[11].
This paper shows the use of 4DryField® PH for both hemostasis and adhesion prevention. In a first approach
4DryField® PH was only used in severe clinical cases: 1) complicated hysterectomies with extended areas of
diffuse bleeding and 2) deep infiltrating endometriosis with large peritoneal defects. The hemostatic effect of
4DryField® PH is evaluated and its efficiency in adhesion prevention controlled on basis of second look la-
paroscopy.
2. Patients and Methods
The present study includes 21 patients who underwent extensive surgery, either complicated hysterectomy and/
or resection of deep infiltrating endometriosis leaving large areas of peritoneal defects. The patients consented to
publication of her intraoperative photographs obtained during laparoscopy not allowing referring to patient´s
identity.
From September 2012 to October 2013, 4DryField® PH (Co. PlantTec Medical GmbH, Bad Bevensen, Ger-
many) was applied in a total of 21 patients (23 - 44 years of age, mean age 34, 5 years).
Ten patients (36 - 65 years of age, mean age 48, 2 years) had surgery due to uterus pathology all associated
with diffuse bleeding and leaving large peritoneal defects. Indication for surgery was large size Uterus myoma-
tosus in 5, Adenomyosis uteri in 3, and malignant disease in 2 patients (1 endometrial carcinoma, 1 cervical car-
cinoma stage III). Surgery of the latter was systematic pelvic and para-aortic lymph-adenectomy combined with
insertion of retrograde stents of both ureters.
In 4 of patients with uterus myomatosus the adnexa were resected and the uterus removed by morcellation. In
consequence of severe adhesions repair of small and large intestine became necessary in one patient.
All patients were treated laparoscopically.
In all cases 4DryField® PH was applied for diffuse oozing mainly from blood and lymph capillaries from the
vaginal stump or the area of lymph node resection.
The hemostatic effect of 4DryField® PH became evident by clot formation in all cases shortly after applica-
tion of the powder. The use of further adjuncts was not necessary. Remaining white powder was dripped with
saline solution to transform powder particles into a glassy gel to generate the adhesion prevention capability of
4DryField® PH as gel. Finally in all cases, Robinson drains were inserted.
The hemostatic efficiency of 4DryField® was judged by subjective assessment of the surgeon (MK). Patient
records were evaluated for quantitative parameters of peripheral blood (hemoglobin, leucocytes, C-reactive pro-
tein), temperature, drain loss, stay of drains, and in-hospital stay of patients.
The patient with endometrial cancer had stage pT2, pN0, pL0, R0, G2. The intra-operative lavage revealed
positive cytology. Postoperative chemotherapy regimen was planned with Carboplatin/Taxol. However, the pa-
tient refused this treatment. Characteristics of women with uterine pathology are summarized in Table 1.
Ten patients (23 - 44 years of age, mean age 34, 5 years) had deep infiltrating endometriosis mostly combined

M. Korell
535
Table 1. Characteristics of patients with surgery for uterus pathology.
Age
[yr] Location of
adhesions Diagnosis Surgery of
uterus Surgery of
adnexa Lymphnodes Other Bleeding
65*
right ileo
-cecal
after appendectomy
endometrium carcinoma
pT2 pN0 pL0 Vo R0
G2 positive peritoneal
lavage cytology
total
hysterectomy
bilateral
adnexectomy
bilateral pelvic
lymphadenectomy
diffuse
bleeding
46
all lower abdominal
and pelvic organs
cervical carcinoma III
radical
hysterectomy
bilateral
adnexectomy
bilateral pelvic
and para
-aortic
lymphadenectomy
double
-j-cath
of
both ureters
severest
diffuse
bleeding
34
all lower abdominal
and pelvic organs
adenomyosis uteri
squameous metaplasia
of endocervix
radical
hysterectomy
bilateral
adnexectomy
severest
diffuse
bleeding
41
all lower abdominal
and pelvic organs
uterus myomatosus
adenomyosis uteri
left endometrial cyst
total
hysterectomy
left
adenexectomy
repair of small and
large intestine,
rectum
diffuse
bleeding
50
uterus myomatosus
total
hysterectomy
diffuse
bleeding
39
severely enlarged
uterus myomatosus
total
hysterectomy
(morcellator)
diffuse
bleeding
50
severely enlarged
uterus myomatosus
total
hysterectomy
(morcellator)
diffuse
bleeding
45
a
denomyosis uteri
coagulation disorder
total
hysterectomy
bleeding
51
severely enlarged
uterus myomatosus
total
hysterectomy
(morcellator)
severe
diffuse
bleeding
57
severely enlarged
uterus myomatosus
total
hysterectomy
(morcellator)
severe
diffuse
bleeding
*Patient with second look laparoscopy.
with abdominal adhesions, 1 patient (41 years of age) had severe adhesions following multiple previous surge-
ries. Leading symptom in all patients was significant pain in the lower abdomen. The patient with multiple pre-
vious surgeries suffered from pain and bowel obstruction.
Table 2 summarizes the intraoperative characteristics of endometriosis patients as well as surgical interven-
tion on neighboring organs involved. 6 of 10 patients necessitated excision of large bowel and/or rectum endo-
metriosis, 1 repair of small intestine. Three patients had involvement of ureter, in 2 the bladder had to be par-
tially resected and/or repaired. As a sum, only patients with extensive disease were considered for treatment with
4DryField® PH. All patients were treated solely with laparoscopic surgery.
3. Second Look Laparoscopy
In 6 of the 21 patients a second laparoscopic surgery was performed. In 5 women with desire for pregnancy
(23.5 - 36 years), a planned second look laparoscopy was performed to release the ovariopexy 8 weeks (7 to 9
weeks) post-operatively, which allowed judgment of abdominal adhesion formation. The patient with positive
intra-operative lavage upon first surgery and refusal of chemotherapy developed free fluid in the abdomen and
had second look surgery for tumor staging.
4. Results
In all patients intra-operatively the hemostatic effect after administration of 4DryField® PH was judged as

M. Korell
536
Table 2. Characteristics of endometrioses patients and surgical interventions on neighboring organs involved in the disease.
Age [yr
]
Uterus Adnexa Vagina Rectum Ureter Bladder Other
42 myoma left adnexectomy
45 left ovatian
cystectomy resection of large
right-side hydatide
33
left ureterolysis
33 hysterectomy suture after
resection suture after
resection
suture after
resection suprapublic
drain of urine
36 suture after
resection suture after
resection
suture after
resection suprapublic
drain of urine
24* bilat. ovaropexy
revision of
recto-sigmoidal
junction
extensive left
ureterolysis
29* bilat. ovarial
cystectomy
suture of rectum and
sigma after resection
appendectomy,
suprapublic drain
28* adenomyosis
uteri extensive lesion in pouch of Douglas
affecting vagina and rectum
36* suture after
resection left ureterolysis double-j-cath
left ureter
28*
suture after resection
41**
repair of small intestine
*Patients with second look laparoscopy; **Patient with sole adhesion disease.
to be evident. In cases with massive bleeding, the application of 4DryField® PH resulted in rapid sufficient he-
mostasis. There was no necessity for other hemostatic agents, or for conversion from laparoscopic to open sur-
gery.
Postoperative transfusions were not necessary. Hemoglobin levels did not fall below 10 g/L. In three women
the C-reactive protein level exceeded 10 mg/dL (normal value < 0.5 mg/dL), which was accompanied by mild
leukocytosis in all three (10.5/nL, 13.1/nL, 16.1/nL) and elevated temperature (39.1˚C) in one patient.
Overall postoperative loss from Robinson drains was 497 ± 339 mL (55 to 1365 mL). Drains were removed at
day 4.3 ± 1.3 (3 to 8 days). Discharge from hospital was at day 6.2 ± 1.4 (4 to 9) days. Patients were free of pain
without necessity of elevated medication for pain relief. There were no local infections. All wounds had healed
per primam.
Six women underwent second look laparoscopy. Considering the extent of the initial disease upon first sur-
gery the incidence of abdominal adhesion formation was 2 of 5 women being completely free of adhesions, 2
having few non-vascularized adhesions apart from the area of 4DryField® PH application. One patient had sig-
nificant adhesions which, however, again were somewhat apart from the area application of 4DryField® PH
powder. In this patient, the fossa ovarica treated with 4DryField® PH appeared to be free of adhesions.
The patient with endometrial cancer having had refused postoperative chemotherapy presented with free liq-
uid in computed tomography at 1-year follow-up. Second look laparoscopy for tumor staging revealed the pelvic
situs, i.e. area of hysterectomy and both iliac lymphadenectomies without local recurrence. However, ubiquitary
there were white spots predominately at the diaphragm and anterior abdominal wall disclosing to be peritoneal
metastases of adenocarcinoma. There was no adhesion formation neither in the pouch of Douglas nor in the
areas of extensive lymph node resection.
Figure 1 demonstrates the technique of application of 4DryField® PH on a slightly bleeding peritoneal defect.
After complete hemostasis has been achieved powder is transformed into gel by gentle dripping with saline so-
lution. Figure 2 shows the result after 8 weeks with the areas of former peritoneal defects being free of adhesion
pathology.
5. Discussion
Post-operative hemorrhage, besides infection, is still the second most early complication following gynecologi-

M. Korell
537
Figure 1. Application of 4DryField® PH powder to the area of left
ovarian fossa (A); and pouch of Douglas (B); 4DryField® PH pow-
der in left ovarian fossa (C); and pouch of Douglas (D) is trans-
formed into gel.
Figure 2. Laparoscopic photographs of the pouch of Douglas (A)
and fossa ovarica (B) during second-look laparoscopy 8 weeks af-
ter 4DryField® PH application. (A) Pouch of Douglas is complete-
ly healed and free of adhesions; (B) Fossa ovarica is completely
healed and free of adhesions.

M. Korell
538
cal surgery [3] [4]. This also accounts for the laparoscopic approach [4] [12]. Hematoma, prolonged lymphatic
oozing, combined with prolonged necessity of drainage contributes to the incidence of infections, especially in
obese patients. The hemostatic effect of 4DryField® PH could be observed during surgery by means of visible
clot formation and ceasing of bleeding. This was especially impressive in one patient with resection of multifoc-
al endometriosis. Overall, considering that in this study 4DryField® PH was only applied in patients with exten-
sive surgical procedures, the rate of post-operative drain loss indicates that there is a substantial styptic effect
on blood and also on lymph capillaries. Furthermore, there was no necessity for use of another hemostat or to
switch from laparoscopic to open access. Remarkably, elevated C-reactive protein levels were not always ac-
companied by leukocytosis or fever, and might be due to degradation activities as it is in polysaccharide ab-
sorption.
The rate of adhesion formation after extensive surgery in pathologies comparable to our patients can be pros-
pected to be up to 90% [6] [7] and their consequences respectively possible complications are substantial [13].
With the individual risk of patients―i.e. pain, infertility, obstruction of intestinal passage to ileus―being always
in the foreground, recently the economic aspects have been discussed by Ray et al. [14] for the US, and
Tingstedt et al. for Sweden [15]. Introduction of laparoscopy did somewhat diminish the incidence of adhesion
formation but not substantially eliminate the problems and costs [13]. Gynecologic surgery plays an important
role in readmission rate [16]. Gynecologists and increasingly individual patients and patient organizations put
more and more attention on abdominal adhesions and their consequences.
In women who are in child bearing age and who have the wish for children gynecological surgery faces the
dilemma that the surgical trauma might induce adhesions—the most frequent cause for secondary female infer-
tility [17]. Thus, the second look laparoscopies in the present study deserve special consideration. Present data
are promising but however, need to be confirmed by multicenter studies.
The capability of 4DryField® PH to be functional as hemostat and adhesion prevention agent is very attractive
since two major complications of gynecological surgery are focused on. The excellent outcome with only few
adhesions upon second look laparoscopy stresses the dual potential of 4DryField® PH. Considering the efficien-
cy in adhesion prevention 4DryField® PH could be helpful also for other abdominal or urological surgeries sur-
gery involving the peritoneum and bearing the risk of adhesion formation.
6. Conclusion
4DryField® PH with its twofold effect in hemostasis and adhesion prevention is a promising contribution to the
operative treatment of endometriosis, adhesions, and extensive uterus disease. The preliminary results in patients
with extensive pathologies support its use in operative gynecology, and furthermore, also for other surgeries
with peritoneal trauma. Prospective randomized studies are necessary to prove these promising results in larger
series.
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